Site Management Clinical

ELIZABETH OLAFEMI

Morris Plains, New Jersey. ****0 *********@*****.*** 973-***-****

https://www.linkedin.com/in/elizabeth-olafemi

PROFESSIONAL SUMMARY

Dedicated and experienced Clinical Research Associate with a proven track record of effectively managing and monitoring multiple site locations, clinical site evaluation, initiation, maintenance and close- out visit in accordance with the company SOP’s and GCP guidelines, while ensuring compliance with protocols, regulations, and quality standards.

Seeking to contribute my expertise in data collection, site management, and regulatory compliance to a dynamic clinical research team.

SKILLS

Clinical trial monitoring and management

Regulatory compliance and documentation

Monitoring Pre-study Visit, Site initiation Visit, Interim monitoring Visit, and Close-out Visits

Oncology Clinical Trials

Investigational New Drug (IND), New Drug Application (NDA)

Patient recruitment and retention strategies

Electronic data capture (EDC) systems

Strong knowledge of ICH-GCP guidelines

Excellent communication and interpersonal skills

Problem-solving and critical thinking

Reporting and Documenting

THERAPEUTIC EXPERIENCE:

Oncology;

Breast Cancer (Ph II) (Ph III),

Prostate Cancer (Ph II)

WORK EXPERIENCE

Clinical Research Associate I April 2021 – Present

Clinproxy Research Services Henderson, NV

Manages and monitors multiple phases II, III and IV of clinical trials in Oncology ensuring adherence to protocols, GCP guidelines, and regulatory requirements.

Conducts site initiation, routine monitoring, and close-out visits to ensure data accuracy and patient safety.

Collaborates with investigational sites to provide training on protocol implementation, source document verification, and regulatory documentation.

Oversees site recruitment, enrollment, and retention strategies.

Assists in the planning, implementation, and coordination of Breast Cancer clinical trials, maintaining strict adherence to study protocols and regulatory guidelines.

Acts as a liaison between investigational sites and sponsors, facilitating clear communication and efficient problem resolution.

Manages site communication and ensures timely submission of regulatory documents, IRB submissions, and safety reports.

Collects, documents, and maintains accurate clinical trial data in electronic data capture systems (EDC) and trial master files (TMF).

Study Coordinator September 2019- March 2021

Universal Institute Livingston,NJ

• Overseeing the trouble-free running of clinical trials

• Collected data obtained from research, coding and analyzing it

• Managed budgets set aside for research

• Communicated with participants regarding study objectives

• Administered questionnaires and monitoring participants to ensure they adhere to the study’s rules

• Liaising with laboratories regarding research findings

• Monitored the study to ensure that it complies with protocols, is ethically-conducted and follows regulatory standards

• Maintained research records of study activity, including case report forms, drug dispensation records or other regulatory forms as per FDA guidelines

• Directed the collection, labeling, storage and transport of all specimens

• Made sure that all equipment and supplies needed for the study are in-stock and in good working order

EDUCATION/CERTIFICATION

Master of Science – Information Technology Management/ Malaysia.

Bachelor of Science - Sociology/Nigeria.

Google Technical Assistant/USA

ICH/GCP Certified /USA

SOFTWARE PROFICIENCY

Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)

Electronic Data Capture (EDC) Systems (Suvoda and Medi Data Rave)

Clinical Trial Management Systems (CTMS)

Interactive Voice Response System (IVRS)

Electronic Trial Master File ( Oracle E-TMF )

Veeva vault

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