Senior Associate, Clinical Operations

Transcend Therapeutics•New York, NY

4d•$70,000 - $100,000

About The Position

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.

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
Proficient knowledge of GCP/ICH, drug development process, clinical operations
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

Nice To Haves

Experience in conducting studies in psychiatry-related indications is preferred

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
Assist in preparation and coordination of Investigator Meetings, as needed
Additional responsibilities as required