Breana Watkins

• Track enrollment metrics and develop strategies to improve recruitment and retention
• Oversee daily clinical trial operations, ensuring compliance with protocols, GCP, and regulatory requirements
• Manage and mentor clinical research staff, including coordinators and research assistants
• Coordinate with sponsors, CROs, and investigators to ensure timely study start-up, enrollment, and closeout
• Review and approve source documentation, eCRFs, and regulatory binders for accuracy and completeness
• Lead site audits and monitoring visits, addressing findings and implementing corrective actions

• Coordinated clinical trial activities and ensured compliance with regulatory requirements.
• Managed participant enrollment and maintained accurate study documentation.
• Collaborated with investigators to develop and implement study protocols.
• Scheduled and organized monitoring visits for sponsors and regulatory bodies.
• Trained and supervised junior research staff in study procedures.
• Facilitated communication between study teams and external stakeholders.
• Monitored data collection processes to ensure quality and consistency.
• Assisted in the preparation of reports for institutional review boards.
• Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
• Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
• Monitored patient safety during clinical trials according to established guidelines.
• Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
• Reviewed CRFs for completeness and accuracy before database entry.
• Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
• Assisted in the preparation of Institutional Review Board submissions for clinical trials.
• Kept patient care protocols and clinical trial operations in compliance.
• Conducted routine visits to research sites to ensure compliance with protocol requirements.

• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Directed daily data entry and query resolution of multiple studies for the clinical trials department.
• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Educated patients regarding all facets of clinical study participation.
• Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
• Coordinated clinical trials focused on disorders such as Endometriosis, Atopic Dermatitis, Sickle Cell Disease, Type II Diabetes, and Hot Flashes.
• Created source documents, maintained reports, and met with monitors on routine site visits.

Handled study start-up

• Maintained Regulatory Documents
• Ensured compliance with company procedures, SOPs, and ICH guidelines.
• Attended sponsor investigator meetings and site monitoring visits when applicable.
• Interact and correspond with cooperative groups, Institutional Review Board, and regulatory agencies. Assisted the Study Coordinator with subject visits and scheduling.
• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• · Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.