Sponsor Clinical Research

ADEDEJI ADEWUNMI, BSc, MSc, MBA

336-***-**** ******************@*****.*** Baltimore, MD

OBJECTIVE

A position in Clinical Research, where my clinical experience as a Clinical Research Associate and a Project Specialist, clinical trials expertise, strong work ethics and leadership skills will be best utilized to meet scientific research goals. Seeking a position in clinical research that protects the rights, safety, and wellbeing of human subjects in clinical trials, ensure trial data are accurate, complete, and verifiable using the ALCOA principles and to ensure trials are conducted according to ICH-GCP guidelines and regulatory authority requirements. Summary of Qualifications:

● Extensive knowledge of monitoring procedures.

● Extensive knowledge of the clinical trial process.

● Detailed knowledge of GCP and ICH guidelines

● Sound understanding of state and federal regulatory requirements.

● Comprehensive knowledge of applicable sponsor SOPs for site monitoring. THERAPEUTIC EXPERIENCE:

● Ophthalmology - Glaucoma

● Endocrinology - Diabetes Type II

● Vaccine – COVID-19

● Infectious Disease - HIV

● Psychiatry- Major Depressive Disorder, Eating Disorder WORK EXPERIENCE

Clinical Research Associate II

Navitas, Rockville, MD Oct 2019 – Present

● Ensure procedures are in place for appropriate optimization of patients into the clinical trial.

● Monitor the assigned clinical trial following company SOPs and in accordance with GCP.

● Plan the requirements for clinical trial material, ordering clinical trial material (head office or local comparators), set up and monitor the systems whereby the Clinical Research Assistant will ship CT material to the investigator, maintain procedures to account for the CT material, check the expiration of CT material and request extensions if necessary.

● Is the point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials.

● Participate in global conference calls and meetings to review progress of ongoing clinical trials.

● Track completed CRFs and set up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion.

● Review all SAEs, ensure Medical Director sign-off, that sites are notified and that all company procedures are complied with.

● Maintain project files including ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigator's brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.

● Manage the Contract Research Organizations – initial identification of a suitable partner, definition of CRO responsibilities, communication plan, divisions of responsibility, milestones, contract with CRO, review monthly status reports, and the interactive management of CRO to ensure project success.

● Participate in departmental planning sessions and SOP development.

● Manage assigned investigational sites to assure adherence to protocol, FDA regulations, and ICH GCP guidelines.

● Perform pre-study visits to help identify adequate study sites that have the resources and facilities to conduct the clinical study.

● Assist in the preparation of study start-up documents including 1572s, CVs, Clinical Study Agreement (CSA) and amendments, investigator study files, enrollment logs, etc.

● Conduct protocol training to staff at investigator site during site initiation visit to ensure that site is equipped to conduct the clinical study.

● Monitor the conduct of the study at assigned clinical study sites and review source documents, CRFs, regulatory documents, informed consents, investigational product, clinical supply accountability and AE/SAE reporting.

● Ensure that all CRF data are of high quality and sent in-house well within project deadlines.

● Perform drug accountability and review drug accountability records to ensure consistency with the physical inventory of the study medication.

● Ensure that serious adverse events (SAEs) are reported to the sponsor and IRB in a timely fashion and appropriately documented in the patient’s source documents and CRFs.

● Assist in the development of checklists for pre-site visits, site initiation, monitoring visit and closeout visit.

● Provide instructions to the investigational site staff on their roles and responsibilities in conducting clinical studies, evaluate site performance, and provide re-training as necessary.

● Collect and review regulatory documents.

● Assist in ensuring that all site data queries are addressed in a timely fashion.

● Close the investigational site at the end of the study ensuring that all study supplies are returned to the sponsor as required or destroyed by the site. Clinical Research Associate I

Navitas, Rockville, MD Feb 2017 – Oct 2019

● Ensured all enrolled subjects meet protocol eligibility which includes all inclusion and exclusion criteria, pre-screening and screening procedures and are properly consented per the protocol and GCP guidelines.

● Prepared and presented project progress reports to keep management and team informed on an ongoing basis.

● Reviewed protocol violations with investigators and site staff, by implementing corrective actions to ensure future compliance of the protocol and all applicable regulations.

● Functioned as the first line of contact between my assigned sites and sponsor(s).

● Documented site and sponsor contact and study interactions in a timely and professional manner.

● Assisted with resolution of investigational site/data queries according to study specific timelines.

● Liaised with project team members regarding study site issues.

● Provided quality review of the informed consent template.

● Provided study-specific direction, training and mentoring to other CRAs, and support staff as appropriate, and provided guidance to other team members.

● Tracking of regulatory documents by keeping and maintaining a regulatory tracker.

● Tracking of site staff training by keeping and maintaining training tracker.

● Maintained timely and effective communication among team members and site staff. Routinely anticipated and identified potential issues and implemented corrective actions independently.

● Keep project leadership apprised of team issues, seeking guidance as needed.

● Demonstrated effective conflict resolution. Assured compliance with local regulations, Code of Federal Regulations (CFR)/ International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs. Maintained current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan.

● Participated in TMF and on-site audits as requested. Respond to less complex findings without oversight and may require guidance to respond to more complex/serious findings. May be responsible for submission of regulatory packages to ethics committees and/or competent authorities.

● 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 activities are in compliance with the clinical trial Protocol and all applicable governmental and regulatory/ethics regulations.

● Ensured timely reporting of AEs/ SAEs and Protocol Violations.

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

● Communicated with assigned clinical research investigators and staff on a regular basis, documenting the correspondence as per the study specific guidelines.

● Reviewed regulatory documentation/file at the site for completeness, collected updated forms as applicable.

● Ensured site compliance to the protocol and applicable regulations (FDA/GCP/ICH/IRB).

● Responsible for collection and verification of essential regulatory documents. Project Specialist

Navitas, Rockville, MD Jan 2014 – Feb 2017

● Initiated and conducted protocol review, evaluation, study design, and risk assessments of clinical research studies. Communicated with assigned clinical research investigators and staff on a regular basis, documenting the correspondence as per the study specific guidelines.

● Participated in study budget negotiations and reconciled study budget accounts. Communicated with assigned clinical research investigators and staff on a regular basis, documenting the correspondence as per the study specific guidelines.

● Developed informational materials for recruitment of subjects; monitors enrollment goals and modified recruitment strategy as needed. Communicated with assigned clinical research investigators and staff on a regular basis, documenting the correspondence as per the study specific guidelines.

● Oversaw and ensure compliance with regulations, including organizing electronic files and/or filling regulatory documents appropriately; prepared and submitted Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary); prepared regulatory documents for sponsor. Communicated with assigned clinical research investigators and staff on a regular basis, documenting the correspondence as per the study specific guidelines.

● Identified and selected potential subjects by reviewing existing protected health information, screening subjects, and conducted interviews; performed subject interviews and assessment for data required by protocol(s). Communicated with assigned clinical research investigators and staff on a regular basis, documenting the correspondence as per the study specific guidelines.

● Followed up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.) Communicated with assigned clinical research investigators and staff on a regular basis, documenting the correspondence as per the study specific guidelines.

● Reviewed incoming subject adverse event (SAE) information, assisted PI in making submission determination of SAEs, and followed up to determine resolution of adverse events.

EDUCATION

Ogun State University BSc, Political Science

Ogun State University MBA, Human Resources

University of Lagos MSc, Political Science

Lagos State University MSc, International Relations and Strategic Studies COMPUTER & SOFTWARE APPLICATIONS

EDC: Medidata RAVE, InForm

CTMS: Rave CTMS, IMPACT

IVRS: IMPALA, SUVODA

EMR: Cerner, EPIC

eTMF: Veeva Vault, Wingspan

RELEVANT PROFESSIONAL TRAINING/CERTIFICATIONS

The National Institute on Drug Abuse (NIDA) GCP: Good Clinical Practice (ICH-GCP) CITI Program Human Subject Protection (HSP)

CPR and AED certification

Contact this candidate