Job Title: Clinical Trial Coordinator Position Description
Provide support to the clinical operations team to assist with the execution and maintenance of clinical studies and perform relevant tasks as related to trial execution as directed by study team which may include the following and not limited to:
- Assist with tracking study progress and maintaining study status updates (e.g., IRB approvals, regulatory document collection, patient enrollment, SDV status, etc.)
- Coordinate preparation, collection, review and tracking of key clinical study documents (e.g. CDAs, Financial Disclosures, Insurance certificates)
- Coordinate central IRB submissions
- Coordinate Clinical Study meetings (e.g. Investigators' Meetings, Advisory Board Meetings, etc.)
- Develop agenda and minutes for meetings
- Track and maintain CT.gov registry or applicable registries
- Track and prepare investigator and vendor budget payments and
- Assist with the maintenance and QC of the Trial Master File
- Perform in-depth clinical review of study data, as necessary
- Data entry of contracts, amendments, WO, MSA, etc, detail in QuickBase/GrantPlan; update investigator site details in CTMS or other system for studies updates;
- Attend T-cons as necessary;
- Occasional travel may be required (possible 15 to 25% per year);
- Ad hoc activities, as directed
- Must have a minimum of a 2-4 year college degree and/or clinical trial experience in the pharmaceutical or biotechnology industry.
- Must possess a strong desire to learn and develop in the clinical trial arena.
- Proficient in Microsoft Office (e.g., Word, Excel, Power Point, and Outlook)
- Must possess strong organizational, communication and interpersonal skills.
- Ability to multi-task is essential with a strong work ethic
- Experience working in a team across multiple functional areas and ability to work independently
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.