Clinical Research Associate (CRA)

Oyster Point Pharma, Inc. - Princeton, NJ

Full-time

The CRA will be responsible for site management and reporting of trials in accordance with company plans/objectives, ICH/GCP, local requirements and company standard operating procedures. Additional responsibilities will include in-house data review and occasionally leading the planning and development of study set-up.

· Acts as primary point of contact for investigative sites and cross functional teams and escalates to the study lead as necessary.

· Assists in the development of study-related documents such as study manuals, monitoring plans, informed consents, recruitment materials and other study related tools.

· Supports in the development and design of CRFs, including participating in the EDC and IWRS specification process and User Acceptance Testing (UAT).

· Performs in-house review of clinical data listings for completeness and accuracy and escalate issues as needed.

· Responsible for the development and distribution of study newsletters and tracking/reporting of recruitment updates.

· May participate in co-monitoring and/or training visits, TMF and on-site audits as requested.

· Participates in the training of investigative sites and third-party vendors.

· Assists with providing oversight of CROs and vendors, including managing cross-functional teams.

· Works to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and local government regulations.

· Assists with the organization and management of internal meetings, investigator

meetings and other trial specific meetings as required.

·Performs other work-related duties as assigned.

BA/BS or higher in a scientific field. Minimum of 2 years of clinical trial experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting.

Job Type: Full-time

Experience:

  • clinical trial: 2 years (Required)

Education:

  • Bachelor's (Required)