RESUME

Dickson Ndu

*** ***** ******* **. aduqsv@r.postjobfree.com,

346-***-****

QUALIFICATION SUMMARY

Experienced Clinical Research Coordinator with years of experience in the Pharmaceutical, Clinical Research and Food industries. Proven record of successful execution of projects in the most challenging environments. Very good work ethics, good oral and written communication skills, with a history of exceeding set goals and adapting to changing business needs. Team player with unequalled leadership quality and experience. Willingness to learn and grow, target driven and self-motivated.

-Knowledge and practice of protecting human subjects of Clinical research.

-Experienced in developing and adhering to standard operating procedures (S.O.P)

-Superior knowledge of Hazard Analysis and Critical Control Point (HACCP)

-Tract record of implementation of Good Laboratory Practice and Good Clinical Practice (GLP, GCP)

-Patients Care

-Patients safety Coordinator and Data collection, entry and management

-Excellent in patient recruitment, screening and Enrollment

-Excellent knowledge of Good Manufacturing Practice (GMP)

-Performing job functions that adhere to service principles with customer service innovations, service excellence and team work to provide the highest quality care and service to Human subject participants, families, co-workers and others

-Expert in building and sustaining relationships with clinical trial participants during the course of clinical research

-Strong working knowledge of MS Office ( Excel, Word, Power Point)

-Ability to build quick rapport with Patients, families and obtain Informed Consent and their cooperation with understanding of Biomedical Research Ethics.

-Excellent understanding of working with all research stakeholders and regulatory Authorities ( within/ without)

-Multiple tasking skills, coordinating the activities of PIs, Physicians, Psychologists and other Social service workers, after care service provision.

-Excellent and timely data collection and management.

-Maintenance of regulatory binders, active involvement in monitoring visits and site audits, QC/QA activities in accordance with FDA regulations and GCP/ICH guidelines.

-Excellent working relationship with sponsors/CROs.

- Excellent knowledge of the EDC system and procedures

- Two years remote monitoring/ support experience

INTEREST/GOAL

To work in a fast paced and most challenging technology driven

environment for improve organizational service delivery.

Be indispensible in area of operation.

duties, bringing my experience to bear and ultimately add the needed

values that would bring about prompt service delivery.

PROFESSIONAL EXPERIENCE

Diabetic and Thyroid Center, Fort Worth ( 8 March, 2022 till date)

Functional Accountabilities

Responsible Conduct of Research

Consistently demonstrates adherence to the standards for the responsible conduct of research.

Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.

Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information.

Uses research funds and resources appropriately.

Maintains confidentiality of data as required.

Meets all annual job-related training and compliance requirements.

Research Administration

Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.

Accurately creates, completes, maintains and organizes study documents.

Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.

Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.

Reviews current literature to obtain information relevant to clinical research program, as directed.

Attends study meetings, which could include overnight travel, as requested by principal investigator.

Works well with other members of the research team and seeks and provides input when appropriate.

Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center.

Participant Enrollment

Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan.

Screens subjects for eligibility per the protocol and institutional policies.

Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.

Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction.

Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.

Engages participants/LARs in the informed consent process according to institutional policies.

Follows procedures for documentation of study payments and participation incentives.

Study Management

Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member.

Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies.

Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks.

Suggests improvements to specimen handling processes, when needed.

Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses.

Registers and records participant visits in the appropriate tracking system.

Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.

Coordinates, prepares for and responds to routine oversight body visits and audits.

Performs query resolution and assists with addressing and correcting audit findings.

Data Collection

Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources.

Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).

Ensures that queries are resolved within sponsor and institutional timelines.

Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation.

Ensures secure storage of study documents.

Pierge Healthcare Services, Houston, TX 2013-2015

Patient Care Specialist.( Part-Time, evening)

Diagnostic Clinic of Houston, Jan 8,2011—March 31st,2013

Clinical Research Coordinator

Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates, and practices.

Prepare and submit for review accurate source documents related to all research procedures.

Prepare and submit Case Report Forms (CRFs) and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other required fields.

Enter data into research databases, systems, and applications for ongoing studies.

Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard Operating Procedures and regulatory processes and considerations.

Maintain all professional licenses and certifications, if applicable.

Maintain a current clinical trial and clinical research study Good Clinical Practice (GCP) knowledge base, serve as an expert resource to the client in a regularly changing field, and address identified knowledge and skill gaps related to role.

Assist preparing and submitting for review accurate source documents related to all research procedures.

Assist clinical and research staff by ensuring that Case Report Forms (CRFs) are completed.

Document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other required fields.

Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB).

Participate in developing and maintaining research protocol documentation and operations.

Assist researchers with study testing, observating data entry and other duties associated with study sessions.

Verify study participant information, collect data, and test results.

Assist staff develop, assemble related documentation, and maintain regulatory binders for all protocols.

Perform accurate and timely data analysis, report results and findings and respond to sponsor queries.

Set up, format, and enter data into spreadsheets to analyze information and create reports.

Assist researchers develop, maintain and complete study data collection forms and source documents.

Assist staff writing and editing clinical research protocols and informed consent forms (ICFs) based upon templates.

Review draft protocols, case report forms, and manuals of operations for clarity and completeness.

Work with staff on the design, development, and preparation of documents such as spreadsheets, letters, rosters, agendas, presentations, and meeting minutes/summaries.

Assist researchers design patient Case Report Forms (CRFs).

Assist researchers with the collection and analysis of research data and samples.

Adhere to applicable Federal, State, and NINDS regulations, policies, and procedures related to clinical research including biospecimen handling shipment.

Comply with processes and procedures required by different types of sponsors and contractual partners e.g., private industry, federal agency, investigator.

Retrieve research related information from medical records, hospital information system and laboratory information system and create spreadsheets and other reports for use in study analysis.

Prepare patient charts for clinic days; provide initial or follow-up assessment forms, patient labels, most recent medication lists and lab and procedure printouts.

Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures.

Schedule and coordinate outpatient and inpatient visits, diagnostic studies, and medical tests.

Liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals, etc.

Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events.

Update and maintain logs and records of patient and family contacts.

Provide continuity of care to patients enrolled on assigned protocols.

Assess participants’ understanding of the information provided during the informed consent process.

Assess ongoing consent through discussions with participants and reinforcement of education.

Identify and intervene to address facilitators and barriers to effective informed consent discussions and decision making e.g., literacy, capacity, language, distress, lack of time, therapeutic misconception.

Obtain or confirm informed consent assent completion prior to the beginning of any studies or therapies.

Assist protocol staff submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.

Assist key research personnel ensure that clinical research activities are performed in accordance with federal, state, and institutional regulations, policies, and procedures.

Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures.

Contribute to discussions regarding feasibility of protocol implementation and execution with a specific focus on clinical issues, available resources, study coordination, participant safety, and data quality.

Provide a redacted copy of the informed consent form for regulatory submission at time of continuing review.

Work with investigators to assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system.

Monitor electronic medical record system to ensure necessary components are present and complete such as data collection forms, progress notes, participant information forms and diagnostic test completion forms.

Coordinate with relevant parties regarding data sharing plan review and tracking of data submission per approved plans.

Schedule and participate in monitoring and auditing activities and coordinate responses to audits.

Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry.

Assess protocols and studies for regulatory compliance, adherence to IRB approvals and Federal standards, such as HIPAA, human subject ethics, privacy, etc. and generate quality assurance reports.

Assist researchers coordinate, facilitate, and prepare site for monitoring visits and FDA audits.

Create and update protocol operating policies and procedures e.g., MOPs as needed.

Identify and develop relationships with institutional or community-based resources or groups that can assist in achieving recruitment goals.

Participate in developing recruitment materials with input of PIs and IRB approval for referral sources outlining eligibility information.

Perform and/ or coordinate outreach activities, as appropriate to meet research recruitment and enrollment goals.

Serve as a communication liaison between interdisciplinary team and the research participant.

Document, collect, record, and retain all research related participant encounters including in person, phone, or electronic in the research record e.g., source documents, case report forms according to regulations, guidelines, and institutional specific policies, including ensuring good documentation practices for all documents.

Maintain the privacy and confidentiality of participant and research data; protect participant, protocol, and scientific confidentiality by ensuring security of research data and personal health information.

Anticipate and consistently meets reporting deadlines, collaborating with PIs and teams to note data trends and identify problems Notes trends in toxicities, participant information, and data collection points.

Collaborate with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs, biologics, and devices.

Organize, prepare, and distribute informational materials and provide support to the educational mission of the study.

Research changes and updates to Good Clinical Practices (GCP) and prepare summaries, job aids and training materials for research staff and new clinical research coordinators.

Prepare materials, coordinate scheduling, track attendance and report results of workshops related research best practices, emerging trends in clinical studies, new literature and findings and regulatory considerations.

Performs problems-solving and of improves processes as needed to resolve complex and or unpredictable situations.

Manage conflicts and issues that arise in clinical research setting, by utilizing strong communication and collaboration skills

Research Coordinator.

The effect of Tirzepatide vs Dulaglutide on major Adverse Cardiovascular

Events in Patients with Type 2 Diabetes ( SURPASS-CVOT). A phase 3, event driven, multicenter, international, randomized, double blind, active comparator, parallel- group study. This study assesses the effect of QW Tirzepatide up to 15mg vs dulaglutide 1.5 mg on CV outcomes when added to the standard of care in Patients with T2DM with established CVD and elevated risk for MACE.

J2A-MC-GZGI: A phase 2 Sttudy of LY3502970 compared with Placebo in Patients who are OBD or over weight with related Commodities for study site 62473

I8F-MC-GPHD

I8F-MC-GPHL

J1I-MC-GZBD

I8F-MC-GPGN

J2A-MC-GZGE

J2A-MC-GZGI

NN1535—4592- COMBINE 2

EX6018-4758

EX9924-4473

CORT 125134-456

PARADIGM

NN99535—4801/SUSTAIN OPTIMIZE

LPS17007

REDIFINE 3

CYPRESS (901-C-2102

PROMINENT

CORT 125134-452

ST-1891-201

Trained and Certified in the

the following Platforms

1.Medrio

2.Suvoda

3.Veeva Vault

4.Fire crest

5.SIP—Shared Investigators platform

6.Medidata Rave EDC for CRC Course

7.GEAR

8.RTSM

9.Connect

10.Various IWRS Systems

11. Various EDC Systems

12.Calyx

13.Oracle System for Investigators

14. IP accountability

15.Subject Retention( the effect of retention on outcome)Trust, Continuity and Communication

16.EMR – Electronic Medical Record( Nextgen, Care Cloud, Advanced MD, Athenahealth)

Work experience at DTC

. Subject enrollment, Informed Consent administration, randomization.

. Vital signs assessment, sample processing and shipping

. Clinical Trial Material Management, Logistics and Ordering, Inventory.

. Managing study documentation, superior data entry,

. Superior query resolving capability, Patient eccentricity

. Site quality and regulatory management and compliance

. Protocol analysis to implement key points in delivering efficient studies.

. Conduct of Subject visits, prompt data entry into EDC

. IP-Subject administration, teaching diary maintenance, visit scheduling.

. Remote monitoring/ support processes

. IP accountability and reconciliation, Master Trial File maintenance.

. Prompt reporting of AEs, SAEs and GEAR.

. Prompt payments to Subjects, re supplies of trial materials to Subjects

. Training of new Coordinators and study Staff on visit conducts, technology innovations that would impact on service delivery, process streamline and improvement.

. Creation of team and enabling environment

for professionalism and ethical conduct of clinical trial,

. Site preparations for: Site selection, Sit initiation, monitoring and close out visits

Double-blind, randomized,placebo controlled, dose-ranging study to evaluate efficacy & safety of PF-04236921 in Subjects with Crohn’s disease who are ANTI-TNF inadequate responders(ANDANTE)

A randomized, double –blind, placebo controlled group, multinational trial, to assess the prevention of Thrombotic events with Ticagrelor compared to placebo on a background of Acetyl Salicylic Acid (ASA) Therapy in Patients with history of Mycardial Infarction.

A multi-center longitudinal, observational study of Patients with Autosomal dominant polycystic Kidney Disease (ADPKD) to establish the rate, characteristics, and determinants of disease progression.

A randomized multicenter study comparing Pixantrone + Rituximab with Gemcitabine + Rituximab in Patients with aggressive B-cell Non- Hodgkin lymphoma who have relapsed after therapy with Chop-R or an equivalent regimen and are ineligible for stem cell transplant.

A phase 1B/2 open label, randomized study of Medi-573 in combination with Sorafenib versus Sorafenib alone in adult subjects with resectable or metastatic hepato cellular carcinoma.

A phase 1B/2 randomized study of Medi-575 in combination with carboplatin plus pacclitaxel versus carboplatin plus paclitaxel alone in adult Subjects with previously untreated, advanced Non-Small Cell Lung Cancer.

A phase 2A, multi-center randomized, single-dose, double-blind, placebo controlled, followed by a multiple-dose, single-blind, double-dummy, active controlled, iterative dose study to evaluate the PKs, safety, efficacy, tolerability and PDs of Sotatercept (ACE-011) for the correction of Anemia in Subjects with End Stage Renal Disease (ESRD) on Hemodialysis.

Bearss Medical -Clinical Research, Tampa, FL Jan 20th 2008—Aug 31st,2010

Senior Study Coordinator/Assistant Clinical Research Manager.

Collects and manages Patients and Laboratory data for clinical Research Projects.

Schedule Study visits and provide necessary instructions.

Assist in creating and updating case report forms or source documents.

Extract data from the medical records and enter medical information/data onto Protocol specific case report forms, study flow sheets and other required study forms.

Assist in identifying eligible subjects.

Create and perform QA/QC procedures, order supplies for data collection. Develop worksheet/ tools for collecting Patient data.

Assist with preparation of protocols, informed consents, amendments and other necessary documents for review by the IRB and Sponsors.

Maintains investigator/ Sponsor files in accordance with FDA and GCP guidelines.

Assist in assessing vital signs and perform other job functions adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service to patient and families.

Study medications accountability

Study Subject Checks Procedures

Study Supplies accountability

Therapeutic Experience

Infectious Disease

An observational prospective Registry of the Efficiency, Safety and adherence to Therapy of xxx in Patients chronically infected with Hepatitis C virus .

A multi center, investigator- blinded, randomized comparative study to evaluate the efficacy and safety of oral xxx in the treatment complicated skin structure and skin infections.

A 26-week randomized, confirmatory, controlled, open label, multicentre multinational treat-to-target trial comparing the efficacy and safety of SIBA 200 U/ml three times weekly injected in the evening and insulin glargine once daily in a population of insulin naïve Subjects with type 2 diabetes mellitus currently treated with OADs qualifying for intensified treatment.

A phase 11, four-week, multi-center, double-blind, placebo-controlled parallel group study to evaluate the safety and efficacy of EGT0001442 in Subjects with type 2 Diabetes Mellitus with an ascending dose safety and pharmacokinetic evaluation period.-

The Effect of LY2189265 on Blood Pressure and Heart Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Patients with Type 2 Diabetes Mellitus.

A Randomized, placebo-controlled, Double-Blind, Fixed-Dose Study of the Efficacy and Safety of Eszopiclone in Children (6 to 11 years) and Adolescents (12 to 17 years) with attention-deficit/Hyperactivity Disorder-Associated Insomnia.

Clinical Research Associate (CRA) – Monitoring Experience (In – House) Bearss Medical

Directly interacts with clinical research participants, as required, for the research study (non-clinical and clinical procedures). Interacts via telephone, telehealth or in-person.

Coordinates regulatory documentation for research studies that includes maintaining information to comply with industry standards,, FDA requirements or other hospital policies.

Coordinates and schedules procedures as per research study.

Screens, recruits, enrolls and follows subjects according to research protocol guidelines (non-clinical and clinical procedures).

May also assist with the consent processes.

Maintains and coordinates data collection information required for each study that may also include developing CRF's (case report form) or data collection tools.

Assists in developing and implementing research studies, may include writing clinical research protocols.

Conducts research procedures according to the protocol with proper training and check offs to maintain scope of service.

. Monitors patient safety by reviewing records and ensuring appropriate reporting .

.Coordinates data management and collection for national (larger/more complex) research studies or multiple research studies at a given time.

. Serves as primary liaison/lead in preparing annual reports for federal, state, and or/or local agencies on assigned studies.

Submit amendments and continuing review documents.

. Provides in-service training to all study team members and communicates to involved groups.

. Reviews research study protocols to ensure feasibility requirements of the study.

Assists in developing website or other social media for marketing/recruiting based on assigned clinical research study.

.Enters data or assists in assembling data to enter in the assigned clinical trial management system, electronic medical record and/or other required data entry systems

-Investigative Site Monitoring

-Data Integrity

-Site Coordinators Role Review/ Protocol Training

-Subject Safety

-Regulatory documentation and Submissions

-Quality Assurance

-GLP/GCP/CFR/SOPs Compliance

-Investigative Products (IP) storage Compliance

-Protocol Review

-Relationship management between sites and Sponsors

-Appropriate/ prompt reporting of AEs/SAEs and unanticipated problems

-Site Subject Recruitment Training/process Reviews

STUDY COORDINATOR—Clinical Research Jan 4th 2003-Oct 1st,2007

-Recruitment of Study Subjects

-Administering questionnaires

-Gathering lab results

-Abstracting Patient records

-Filling up concomitant medication/illness

-Shipping samples to central lab.

- Managing CRFs and Regulatory binders

-Data collection and Management

-Query resolution

-Study medication and accountability

-Study supplies management

-Working with P.I.(s) and Monitors to execute Studies

-Support project manager in day-to-day activities in trial execution

EMZOR PHARMACEUTICAL LTD Jan 8th, 1998-Dec 31st, 2000.

Quality Assurance Associate.

Emzor pharmaceutical is a house-hold name in the manufacturing of Ethical and OTC drugs.

-Expert in Raw material, intermediate and finished products analysis

-Managed the activities of the In-process control

-Coordinated the factory-wide fumigation processes

-Good in the preparation of Reagents, Media, Saline water and buffer

-Acted as compliance officer- Raw material( Hold and Release )

-Expert in Trend carding and documentation

-HACCP, GLP supervisor

-Excellent knowledge of GMP and ISO 9000,1400 series etc

-Good in the evaluation and sorting of packaging materials

-Managed the chemical and Microbiology laboratory inventories

-Good knowledge of non-technical maintenance of the laboratory equipments including routine clean-ups

-Expert in the processes of identification and isolation of contaminants

-Good knowledge of trend carding and documentation

EQUIPMENTS USED

HPLC, Dissolution,Friability machines, Autoclave, Multitherm shaker, homogeniser, centrifuge etc

CENTRAL DIAGNOSTIC LABORATORIES 1996-1998

Microbiology Laboratory Assistant

CDL provides full Laboratory Services (chempathology, microbiology and other diagnostic services) to members of the public .

-Expert in Media preparation

-Good in sample collection

-Good knowledge of isolation and identification of causative organisms using the SOP

-Excellent in running sensitivity tests and urinalysis

-Good knowledge of differentiation techniques

-Expert in result interpretation and documentation

EDUCATION/ CERTIFICATION

-B.Sc Degree with Honors- Microbiology (University of Nigeria, Nsukka)

- Drug Development/ Clinical Trial Design(RAQA)- ongoing (School of Pharmacy, Temple University- Philadelphia ) Pre- MS

-Dangerous Goods Training – MAYO Clinic,

-Protecting Human Research Participants- National Institute of Health,

- CITI (member ID:1662277)

- CPR / BLS

- Good Clinical Practice (GCP)

- Advanced Ethics of Biomedical Research

- Certified Clinical Research Associate ( CCRA)

- Good Laboratory Practice (GLP)

- Better Process Control

Working knowledge of multimedia, Microsoft Access, office and Excel, Power point.

Contact this candidate