Study Start up Specialist

We are looking to add a Study Start up Manger to our growing team. The ideal candidate will be open to moving into a Project Manager role and be interested in people management as there is a lot of room for growth with this position. This is a hybrid role, WFH 2 days a week.

This role requires strong organizational skills, a deep understanding of clinical trial processes, and the ability to collaborate with cross-functional teams to ensure smooth and successful study initiation.

Responsibilities:

Lead and coordinate all activities related to the start-up phase of clinical trials, including but not limited to: feasibility, site selection, regulatory submissions, committee approvals, and site training.

Ensure that all documentation is accurate, complete, and compliant with regulatory requirements, including but not limited to: IRB submissions, informed consent forms, and investigational product documentation.

Oversee and participates in the preparation and submission of regulatory documents, including but not limited to: approvals, applications, investigator brochures, and other essential regulatory submissions to the necessary authorities and committees.

Collaborate with internal and external stakeholders (e.g., sponsors, CROs, PIs, IRBs, approval committees) to ensure all approvals are obtained in a timely manner.

Work closely with site personnel to ensure the timely initiation of clinical study sites, including contracting, budget negotiation, and site feasibility assessments.

Designs or assists in design of electronic capture databases, if appropriate, and manages all the data collected.

Experience:

Bachelor’s degree and 5 years of clinical research experience

Master’s degree and 3 years clinical research experience