Sr. Clinical Trial Specialist - Tandym
Woburn, MA
About the Job
We are hiring a contract position for a Senior Clinical Trial Specialist. This is a remote role. This position will work closely with cross‐functional teams to ensure site start‐up through close‐out activities are conducted in accordance with Standard Operating Procedures (SOPs) and applicable regulations governing the conduct of clinical trials.
Responsibilities:
- Actively involved in the performance of study feasibility assessments
- Develop and review study documents (e.g., site instructions, diaries, lab manual, Pharmacy Binder, Study Management Plan, etc.) and clinical site documents (e.g., site specific informed consent forms)
- Manage the collection, review and approval of regulatory documents from clinical sites
- Coordinate investigational product release activities across clinical sites
- Initiate, maintain and reconcile the Trial Master File
- Assists in the preparation of Investigator and Study Coordinator Meetings
- Set‐up and maintain tracking systems (e.g., CTMS), tools and report study metrics to support the clinical trial programs
- Manages and tracks study specific payments
- Coordinate communication of tracking information within the study team and to the clinical sites
- Mentor Clinical Trial Associates and peer CTSs, including the onboarding of new hires
- May be responsible for the following activities:
- Manage ancillary vendors, such as a specialty lab or central lab o Assist with training the Clinical Research Associates
- Perform site initiation, routine monitoring and close‐out visits at a limited number of clinical sites, as well as co‐monitoring with Clinical Research Associates
- Review site visit reports, under the direction of the Associate Director or designee
REQUIREMENTS / QUALIFICATIONS:
- Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)
- Fully proficient in clinical trial coordination
- Working knowledge of ICH Good Clinical Practice guidelines
- Must be self‐motivating and able to work on complex issues where analysis of situations or data requires an in‐depth evaluation of variable factors, including inter‐organizational impact
- Must have the ability to build and maintain positive relationships with management and peers
- 10‐30% travel may be required
Source : Tandym
