Clinical Trials Research

Helen Neku

Summary

Highly motivated and detail oriented CRA., with good knowledge of Phase I through phase IV clinical trials from startup to close-out, regulatory review, safety report reviews, and data collection during all four (4) types of monitoring visit, with adherence to ICH-GCP, ALCOA and FDA guidelines. Excellent interpersonal, written and verbal communication skills significantly impact on problem-solving, organizational and time management skills. Therapeutic Experience:

Respiratory/Device- Asthma (COPD)

CNS – Epilepsy, Migraine, Depression

Infectious Disease - HIV

Cardiovascular - Hypertension

Ophthalmology – Glaucoma, Graves

Metabolic - Type II Diabetes

Dermatology – Shingles, Atopic Dermatitis, psoriasis

Women’s Health – Menses Disorders

Oncology – Prostrate Cancer, Breast cancer (solid tumor)

Neurology– Acute Pain, Diabetic Peripheral Neuropathy

Genitourinary (Renal) – Nephrotic Syndromes (CKD)

Rare Disease – Focal Segmental Glomerulosclerosis (FSGS), Cystic Fibrosis (CF), NCKD Work Experience

Senior Clinical Research Associate, ICON, formerly PRA Health Science - (October 2021 – Current)

Assesses IP accountability, dispensation, and compliance at the investigative sites

Verifies Serious Adverse Event (SAE) reporting according to trial specification and ICH-GCP guidelines

Communicates with investigative site

Updates applicable tracking systems

Ensures all required training is completed and documented

Serves as observation visit leader

Facilitates audits and audit resolution

Mentors junior level CRAs and serves as a resource for new employees

If responsible for supervising other CRAs: Schedules and reviews trial task, provides leadership in the diversity of services to clients ensure that staff fulfill their responsibilities in accordance with PRA’s policies, procedures, and SOPs, and ensures HR processes are properly implemented

Serves as a preceptor for new CRAs participating in the CRA Bridge Program

Functions Independently with minimal oversight required

Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines

Assess the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs sites personnel on the proper conduct of clinical trial data collected, either onsite or remotely

Reviews and verifies accuracy of clinical trials data collected, either onsite or remotely

Provides regular sites status information to team members, trial management, and updates trial management tools

Completes monitoring activity documents as required by PRA SOPs or other contractual obligations

Works closely with other clinical team member to facilitate timely resolution of trial and /or clinical issues

Escalate site and trial-related issues per PRA SOPs, until identified issues are resolved or closed

Performs source document verification and query resolution

May serve as subject matter expert for CTM on monitoring related activities

May be assigned to complex studies and/or sites

Provides leadership skill to assigned projects and within the Clinical Operations departments Clinical Research Associate, CromSource - (October 2018 – October 2021)

Conduct pre-study, initiation, monitoring, and closeout visits for research sites and prepare required documentation. Houston, Texas.

Email: ***********@*****.***

Phone: 281-***-****

Management of daily operations of investigational site activities on assigned clinical trials, ensuring compliance with international guidelines, local regulations and corporate policies and procedures.

Conduct site initiation visits; train site personnel on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.

Conduct site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study

Partner with cross-functional team (e.g., clinical data management, medical teams) with query management, data reviews and resolution.

Assist with assessing current and new processes, identifying opportunities, and implementing solutions to improve efficiencies within and across related functional areas

Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, SOPs, and US regulations

Deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities

Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.

Perform adverse event (AE) and serious adverse event (SAE) reporting and follow-up.

Assess patient recruitment and retention Performed onsite Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities as assigned to ensure facilities are adequate, investigative site staff are adequately qualified and the site's activities are in compliance with the clinical trial Protocol and all applicable governmental and regulatory/ethics regulations.

Assure timely reporting of AEs/ SAEs and Protocol Violations

Maintain a working knowledge of GCP, Corporate global SOPs and applicable client SOPs.

Review study data, Case Report Forms (CRFs) or Electronic Data Capture (EDC), against site source documentation and discusses discrepancies with investigative site staff.

Communicate with assigned clinical research investigators and staff on a regular basis, documenting the correspondence per protocol and specific guidelines.

Review regulatory documentation/file at the site for completeness, collects updated forms as applicable.

Train investigative site staff as necessary.

Provide regular updates to Lead CRA regarding the status of assigned sites (i.e., screening, enrollment, etc.)

Notify project manager immediately of any suspected fraudulent and/or misconduct activities.

Attend team/sponsor teleconferences and/or training meetings as required.

Review protocol violations with investigators and implement corrective actions to ensure future compliance the protocol and applicable regulations (FDA/GCP/ICH/IRB).

Ensure that each investigator understands his/her obligations regarding signing the FDA 1572, ICH GCP, FDA regulations governing the use of investigational products, details of the protocol and the CRFs and overall objectives and expectations with respect to their participation in the clinical trial.

Control investigational product accountability through physical inventory and records review.

Control trial supplies ordering, dispatch, return and destruction, as applicable.

Ensure proper essential documents are in place prior to trial start-up and on an ongoing basis throughout the study as part of the continuous file audit review process.

Conduct and ensured proper trial closeout and retrieval of trial materials as per the Monitoring Plan.

Retrieve and archive relevant documents as per Sponsor and operating procedures.

Maintain frequent telephone contact and/or email contact with the study team and the investigative sites to ensure prompt resolution of any issues and to fulfill requirements of the contract. Clinical Trial Specialist, CromSource (June 2017- October 2018)

Communicated and supported field monitors, IRBs, and outside vendors as to study issues and updates

Ensure schedules follow-up, and completion of research protocols progress as planned.

Interacts and collaborates with sponsors, performance sites, local IRB, Office of Sponsored Research, or Clinical Trials Office to address operational/logistical issues as needed to assure successful conduct of clinical trials

Attends and assist in the preparation of DSMB and investigator meetings

Assists Principal Investigators with management of study activities, including assisting in the coordination of conference calls, preparation of a quarterly newsletter, and interface with data management team and performance sites

Ensures that schedules, follow-up, and completion of research protocols progresses as planned. Works with staff to resolve day-to-day problems.

Implements process of protocol for various clinical trials; coordinates sponsor conducted initiated visit(s); assists in the execution of new IRB applications and processes annual reviews for the IRB committee regarding consent.

Collaborates with PI and/or Research Nurse in submission of protocols, amendments, notices, suspensions, and terminations to the IRB for review and approval. Attends IRB meetings as required and addresses any IRB questions regarding the protocols or consent forms.

Assesses potential patients' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol. Checks all eligibility or ineligibility criteria with the patients' medical record. Verifies information with Research Nurse and/or PI. Enrolls patients onto clinical trials or oversees enrollment process

Interact with patients prior to entering the study and throughout the entire treatment. Monitors the occurrence of adverse events and reports them according to the guidelines of the FDA, sponsoring drug accompany (if applicable) and the IRB.

Supported and corresponded with investigative sites as necessary, including ordering study drug and other trial related supplies.

Assisted with the preparation of clinical team meeting agendas and minutes, and monthly site newsletters

Assure that all study personnel have met necessary CDA and training requirements in accordance with federal regulations. Track and facilitate appointments for subjects. Correction Officer, Tulsa County Sheriff office, Ok. (October. 2010 – May 2017)

(Laboratory Services)

Performs routine tests such as biological, chemical, histological, or hematological, using laboratory apparatus and testing equipment and following standardized procedures to provide data for use in research or scientific experiments.

Collects human specimens such as blood and tissue samples for use in tests and analyses.

Maintains the cleanliness and safety of laboratory according to established standards and procedures utilizing procedures such as disposing of contaminants, washing, and sterilizing glassware and inspecting temperature control equipment.

Gives instructions to individuals and groups concerning laboratory techniques and use of equipment and responds to inquiries from the public, other agencies, and private industries on such matters as laboratory test results, normal test ranges, appropriate tests, or collection of samples

Maintains records on such matters as tests performed, test results, methods, materials, and procedures used, and inventory records; Prepares reports concerning such matters and test results and quality control, in order to provide data for use in the diagnosis and treatment of disease or for research and scientific experiments; Performs related duties such as assigning numbers or codes to samples or specimens for identification purposes

Accession and maintaining submitted drugs and other evidence for disposition

Duties may include categorizing, filing, compiling and/or providing copies of records, journals, manuals, and reference books; and reading pertinent published materials to keep abreast of developments in the field. This person strives to create a positive work environment, effectively communicates with others, and conducts all activities in accordance with safety and security policies and procedures.

Coordinate and keeping track record of all incarcerated individual’s medication data base

Maintain accurate documentation on daily activities and incidents for record- keeping

Practice effective communication with staff to facilitate operations Computer Skills:

EDC (Inform and Rave),

Visit Report (CTMS- Impact)

Microsoft office suite (Excel, word, PowerPoint, etc.), Adobe, Outlook, Windows Explorer, Mac etc.

CTMS-Impact, Aris Global,

eTMF: Veeva Vault.

Professional Memberships/ Certification

.

Society of Clinical Research Associate (SOCRA) - Active Member

IATA Certified (ASCLS P.A.C.E.)

Certified Clinical Research Coordinator (CRC) - CRC Academy Education

MBA, Oklahoma Wesleyan University March 2019

Bachelor’s Degree in philosophy, University of Lagos December 2009

(Minor in Microbiology)

Contact this candidate