Clinical Research Project Manager

Uzo Okwandu 832-***-****

Katy, Texas, ***** **********@*****.***

SUMMARY

Results-oriented and highly motivated clinical research professional with over 4 years of outstanding accomplishments and experience in all areas of clinical research and site management including but not limited to site evaluation, site initiation, interim monitoring visits, site closeout, IND safety reporting, knowledge of ICH/GCPs, budgeting, IRB protocol submissions, on-going regulatory document review. SKILLS

Significant expertise with IMPACT, INFORM, Microsoft Office, Medidata Rave and SMART.

Collective experience in clinical trial designs from Phases I to Phase IV.

Great attention to detail while collecting, authenticating and managing clinical trial data at multiple clinical sites across the country.

Strong commercial awareness and ability to motivate others while building effective relationships with trial center staff and colleagues

Excellent numerical, written and verbal communication skills.

Highly proficient with EDC, CTMS and eTMF.

Sound judgement necessary to ensure all protocols/processes are followed at a site level and all challenges are effectively reported.

TRAINING/CERTIFICATION

Root Cause Analysis

GCP and Human Subjects Protection Training

Metabolic Disease Case Studies and Findings.

Adverse Event Reporting Certification

THERAPEUTIC EXPERTISE

Pulmonary/Respiratory

Asthma

Bronchitis

Allergy

Acute Respiratory Distress Syndrome (ARDS)

Rheumatology

Arthritis

Rheumatoid Arthritis

Osteoarthritis

Cardiology/Vascular Diseases

Heart Failure

High Blood Pressure (Hypertension)

Stroke

Urology

Urinary Tract Infection (UTI)

Prostate Disorders

Erectile Dysfunction

EDUCATION

Bachelor of Technology, Chemical Petro-Chemical Engineering University of Science and Technology, Port Harcourt, Rivers State. GPA – 3.54

MBA in Business Administration (Completion in 2017) University of Oklahoma, Norman, Oklahoma, USA.

GPA – 3.75

PROFESSIONAL AFFILIATIONS

Member, Project Management Institute (P.M.I)

PROFESSIONAL EXPERIENCE

NCGS Inc, Charleston, SC, USA 2014 – Present

Chiltern International Inc, Wilmington, NC, USA 2013 – 2014 Clinical Research Associate (Contract Positions via Agency) Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB, the company's standards, guidelines and policies, and writing of monitoring visit reports

Maintain a professional, timely and effective communication among team members and site staff.

Proactively participate in Business Development client presentations and bid defenses.

Ensure compliance with CRF, State regulations, ICH and GCP guidelines and INC Research and sponsor SOPs.

Maintain current regulatory documentation according to Essential Regulatory Document Guidelines (ERDG) and Trial Master File (TMF) Plan.

Monitor all types of clinical trials, participates in all types of site visits and ensure Principal Investigator (PI) integrity.

Ensure compliance with all protocol requirements and ensure timely reporting of AEs/ SAEs and Protocol Violations.

Provide regularly reviews the status of contents of the site Regulatory Binder and perform source document verification (SDV) according to contractual requirements.

Facilitate timely completion and submission of CRFs according to Clinical Monitoring Plan

(CMP) and / or Data Management Plan (DMP) as well as Data Clarification Forms (DCFs).

Effectively complete and submit visit reports according to SOP/WI or sponsor requirements and requiring minimal revisions.

Track Investigator payments/ milestones as needed.

Prepare for and attends investigator’s meetings as requested and provide training as needed.

Assist with the preparation of study start up materials and tools, as requested and attend clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project Communication, Monitoring and/or Training Plans.

Mentor CRAs and provide training as required.

Assessed IP accountability, dispensation, and compliance at the investigative sites.

Work closely with the Institutional Review Board (IRB) to ensure the protection and over-all well-being of research subjects.

Research Pharmaceutical Services, Fort Washington, USA 2012 - 2013 Clinical Trial Assistant (Fulltime)

Provided general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Clinical Research Assistant(s).

Administered, maintain, and coordinate the logistical aspects of clinical trials according to GCP and SOPs.

Set up, organized, and maintained, clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.

Coordinated the ordering/dispatching and tracking of trial materials (e.g. CRFs, diary, cards, lab supplies, drug supplies) as appropriate.

Communicated with clinical sites for specific requests (e.g. enrollment updates, missing documentation, meeting arrangements, etc.).

Provided daily access to systems such as EDC and CTMS systems.

Processed investigator payments on a quarterly basis.

Ran Protocol Deviation reports each quarter, review for any errors, and forward to the Medical Monitor for approval

Ordered investigational product (IP) for each site as instructed by the CPM

Initiated and managed monthly meeting minutes for internal project team calls

Reviewed Informed Consent Forms (ICFs) for accuracy and errors as needed

Responsible for reviewing and approving timesheets and expenses for 20+ contract CRAs.

Worked with the Clinical Project Manager (CPMs) on issues with the CRAs and budget to several projects.

Contact this candidate