Senior Associate, Clinical Operations

About the role

The Senior Associate, Clinical Operations is a key member of the Clinical Operations team, with responsibility for supporting the operational aspects of one or more clinical trials. The Senior Associate will support the Clinical Trial Manager, CRAs, and the investigational sites.

This position is highly visible in a small, growing organization which may provide for the opportunity for rapid advancement.

Responsibilities

• Assist clinical team during all phases of a clinical study (feasibility, start-up, maintenance, and close-out)
• Support field-based clinical research associates
• Participate in vendor and study team meetings, including drafting meeting minutes, as needed
• Collect and review essential regulatory documents
• Submission and tracking of documents to central IRB
• Distribute materials to study sites, as directed
• Create and maintain study trackers (e.g., contact lists, study status trackers, enrollment)
• Review and maintain documents in the Trial Master File (TMF)
• Support internal data review, as needed
• Participate in creation, review, and revision of clinical SOPs
• Aid in preparation and coordination of Investigator Meetings, as needed

Requirements

• At least 1 year of clinical research experience within a pharmaceutical company or CRO or at least 3 years of experience as a clinical research coordinator
• Experience in conducting studies in psychiatry-related indications is preferred
• Proficient knowledge of GCP/ICH, drug development process, clinical operations

Competencies

• Excellent verbal, written, communication and interpersonal skills
• Detail-oriented, with a desire to ‘get in the weeds’ and understand the nuances
• Flexible, able to pivot when needed in a fast-paced environment
• Able to effectively communicate and collaborate across functions and job levels
• Internally motivated, with a passion for mental health
• Routinely takes initiative