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Transcend Therapeutics · 3 weeks ago

Senior Associate, Clinical Operations

New York, NY

Full-time

Onsite

Entry, Mid Level

$70K/yr - $100K/yr

1+ years exp

Transcend Therapeutics is a late-clinical-stage neuroscience company developing rapid-acting treatments for neuropsychiatric diseases. The Senior Associate, Clinical Operations will support the operational aspects of clinical trials and assist the Clinical Trial Manager and CRAs in various responsibilities throughout the study phases.

BiotechnologyHealth CarePharmaceutical

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

Qualification

Clinical research experienceGCP/ICH knowledgeDrug development processPsychiatry-related studiesFlexibleTakes initiativeCommunication skillsDetail-orientedInternally motivated

Required

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