Sr. Clinical Trial Specialist - Tandym Group

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