Jennifer Mema

• Conduct site initiation, routine monitoring, and close-out visits for multiple clinical trials to ensure protocol compliance, patient safety, and data accuracy.
• Review and verify clinical trial data, source documents, and case report forms (CRFs) to ensure accuracy and completeness.
• Complete visit reports and send out follow up letters to sites within stipulated timeline.
• Collaborate with site staff, investigators, and study coordinators to provide guidance, support, and training on protocol adherence and regulatory requirements.
• Prepare and submit regulatory documents and maintain study files to ensure compliance with FDA and other regulatory agencies.
• Identify and resolve protocol deviations, discrepancies, and issues that may impact quality and integrity of clinical trial data.
• Act as primary point of contact between sponsor and clinical trial sites, facilitating effective communication and issue resolution.
• Maintain comprehensive and organized documentation of all activities, including site visit reports, correspondence, and action items.
• Participate in internal and external audits, assisting in resolution of audit findings and implementing corrective actions.
• Participate in site selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
• Review participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
• Organize and maintain research study regulatory documents in site binder to maintain accuracy and integrity.
• Coordinate and schedule protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
• Mentor team members by sharing suggestions and encouraging ideas to deliver successful studies.

• Conducted site initiation, monitoring, and termination close-out visits to ensure studies are carried out according to SOPs, ICH-GCP, and FDA regulations.
• Completed visit reports and sent out follow up letters to sites within stipulated timeline.
• Ensured sites adhered to FDA, ICH-GCP and HIPPA regulations and that new study updates and guidelines were implemented as required.
• Ensured adherence to local regulations and company SOPs.
• Evaluated and reported site performance and protocol compliance.
• Performed data verification of source documents and ensured CRFs were consistent with source and accurately completed.
• Verified that written informed consent was obtained before each subject’s participation in the trial.
• Performed investigational product accountability and tracked IP supply to ensure sites had adequate drugs for study.
• Completed visit reports and sent both pre-visit and post-visit communication to site in a timely manner.
• Completed administrative tasks such as calendar updates, expense reports, and timesheets in a timely manner.

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• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
• Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
• Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
• Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.

• Collected, evaluated, and modeled collected data.
• Coordinated protocol development, equipment preparation and materials purchasing for planned studies.
• Followed informed consent processes and maintained records.
• Prepared documents, reports and presentations detailing results and conclusions.
• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Coordinated day to day activities of research protocols which include screening, enrollment, and monitoring of research participants.
• Explained process and procedures to educate participant regarding research study.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Responsible for screening, recruiting, and consenting research participants.
• Processed, documented and entered information into database.
• Collected patient information