Senior Clinical Research Associate (CRA)
San Diego, CA or Remote
- Samumed is currently looking for a talented and experienced Senior CRA to join its team.
- The Senior CRA participates in the planning, coordination, and monitoring activities of clinical trials in the Clinical Development Department.
- The Senior CRA will provide project support in the initiation, execution and close out of assigned clinical studies.
- The Senior CRA co-monitors and mentors CRA I and IIs, and may have Clinical Project Manager tasks delegated to them.
- Remote work openings are available for this position.
- Managing designated clinical trials, including investigator selection, analysis of potential patient recruitment, and preparation of trial related documentation (administrative and regulatory documents, consent documents, study manuals, study tools)
- Organizing Ethics Committee submissions with follow through to ensure successful outcome
- Participating in /presenting at Investigator Meetings
- Organizing study Site Initiation Visits (SIVs) and develop SIV slides
- Ensuring procedures are in place for appropriate optimization of patients into the clinical trial
- Preparing for monitoring visits and monitoring the assigned clinical trial sites (6-8 sites) following company Standard Operating Procedures (SOPs) and in accordance with Good Clinical Practice (GCP). Monitoring includes the ability to perform all visit types, pre-study, site initiation, interim and close-out visits
- Planning the requirements for clinical trial material (Investigational Product (IP) and non-IP)
- Serving as first point of contact for investigators/site personnel inquiring about patient inclusion/exclusion criteria for ongoing trials
- Maintaining project files including the Trial Master File (TMF), and the following: Ethics Committee approvals; curricula vitae of investigators and study personnel; clinical investigators 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
- Completing word processing, spreadsheet and database assignments, including, but not limited to, correspondence, records, reports, scanning, emailing, copying, filing and other tasks
- Creating and managing Investigator Site File and ensuring that all documents within the file are complete
- Creating and maintaining contact lists and supportive documents for the Clinical Development Department and vendors
- Tracking completed Case Report Forms (CRFs), and setting up systems whereby completed CRFs are rapidly entered into the database. Ensuring that queries generated during cleaning are responded to in a timely fashion
- Managing patient recruitment strategies to increase patient randomization into the trial (e.g., investigator and research nurse meetings, update newsletters, advertising, and letters to GPs)
- Reviewing all SAEs, ensuring medical director sign-off, that sites are notified, and that all company procedures are complied with
- Participating in departmental planning sessions and SOP development
- Complying with institutional and departmental policies and procedures
- Co-monitoring/mentoring CRAs and CTAs
- Assisting with vendor management and review of specifications
- 4 year life sciences or health care related degree
- Minimum 3 years of experience independent monitoring
- Proficient in MS Office software
- Excellent verbal and written communication skills
Please submit your resume or additional inquiries to email@example.com