Jen Douglas

• Work with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Screen patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Collect data and followed research protocols, operations manuals, and case report form requirements.
• Follow informed consent processes and maintain records.
• Participate in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
• Maintain compliance with protocols covering patient care and clinical trial operations.
• Monitor unit budget to meet financial objectives for spend rate and funding.
• Work independently and collaboratively in team environment.
• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Manage time efficiently in order to complete all tasks within deadlines.
• Excellent communication skills, both verbal and written.
• Collaborate with applicable team members and clients for feasibility assessment.
• Assist in identifying suitable, qualified trial sites within a specified geographical area.
• Clinical monitoring report review.
• Day to day operational management of CRAs and CTAs (in-house and remote) to ensure delivery against contracted scope of work.
• Assign appropriate project specific training for CTAs and CRAs.
• Provide direction and leadership to multiple clinical operations project teams.
• Coordinate & manage clinical deliverables from site start up activities to database lock.
• Provide day to day Ensures implementation of Adagene SOPs and study specific processes.
• Assist in identifying training and development needs and opportunities CRAs and CTAs.
• Support and interface with external vendors and clinical site personnel, as needed.
• Co-monitors study sites with assigned CRAs for assessment purposes. Provide input in development of clinical trial related documents including but not limited to: protocols, case report forms, informed consents, conventions/timelines, monitoring plans, site reference manuals, pharmacy manuals, laboratory manuals, training materials, and site initiation visit slide presentation.
• Initiate contact conducted evaluation visited and subsequently established relationships with selected trial sites to ensure study targets for recruitment, quality and costs are met.
• Assist in supporting regulatory submissions.
• Supervise shipment of study drugs and materials to site as required.
• Assist in ensuring audit readiness, by ensuring eTMF/TMF is always up to date.

• Maintained CTMS accuracy, ensured on-time data collection, coordinated study sample flows, and participated in TMF quality checks.

• Conducted co-monitoring of clinical studies, ensuring effective communication, data reviews, and timely issue resolution.

• Prepared for audits/inspections and efficiently handled post-audit resolutions, while representing Epizyme with pride at various sites.

• Spearheaded efficient study start-up by coordinating with departments like DM, Reg, and CMC, overseeing Clinical CRO teams for feasibility reports, and ensuring timely document collection.

• Facilitated training sessions for CRAs, contributed to the establishment of clinical milestones, and validated final study documentation.

• Reviewed site visit reports, providing quick resolutions and follow-ups, while fostering robust relationships with CROs.

• Performed a pivotal role in the RFP process and BID defense meetings, and synergized with MSL at LMA for enhanced Clinical Operations.

• Contributed actively to SOP updates, training material reviews, and played a significant role in transversal projects within Epizyme, promoting continuous improvements.

• Performed investigative site file reconciliation; requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements.
• Performed source document verification, retrieved Case Report Forms (CRFs) and performed query resolution in a timely manner and oversees drug accountability and safety at investigative sites.
• Ensured Serious Adverse Event (SAE) reporting according to project specifications. Responded to requests from investigative sites in timely fashion.
• Worked closely with Project Directors on assigned projects.
• Communicated common site trends to Lead CRA, Project Manager or other project team Members.
• Implemented and monitored clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and GCP guidelines.
• Conducted site-monitoring visits to assess qualification of potential investigative sites, initiated studies, and instructed site personnel on proper conduct of studies.
• Provided regular clinical status information to team members and project management.
• Performed billable work in accordance with company policies, procedures, and Standard Operating Procedures.
• Worked closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff.

• Provided study information and obtains relevant information as required by protocol, from patients who are participating in, or interested in clinical studies.
• Assisted in recruitment and screening of volunteers, schedules patient visits in EMR, information to potential subjects and those participating in clinical trials and obtains relevant medical history by telephone and in person. Collects relevant medical records when needed.
• Responsible for meeting recruitment goals for each study through advertising when funds are available, referrals and attending health fairs and community outreach.
• Reviewed and administered informed consent form to subjects; allowing them time to read and ask questions. Provided progress notes in EMR and source documents to describe procedures at each visit.
• Planned, prepared and performed tasks required by protocol, which may include, but not limited to obtaining patient medical history and medication lists, phlebotomy and basic laboratory tests. Trained patients on study drug administration.
• Triaged adverse events and communicated with research physician regarding occurrence of adverse and serious adverse events. Followed-up with the subject and collateral informants as needed.
• Provided educational information to subjects. Served as a resource and support person for subjects and families by being POC( point of contact) within the clinical research program.
• Ensured uniform implementation of protocols by completing required documentation in consistent, accurate and timely manner. Assists in preparing appropriate Institutional Review Board (IRB) forms, informed consents, correspondence with sponsor, etc., in accurately and timely manner. May participate in annual IRB approval and update process.
• Collected and recorded clinical research data, assists in patient assessments, scheduling, maintained study files, study supplies and study medication accountability.