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Clinical Research Scientist (Associate Director/Director)

Clinical Research Scientist (Associate Director/Director)

Reports To: Clinical Research Physician

Location: Malvern, PA/ San Diego, CA/ Remote

Job Purpose:

The Clinical Research Scientist will be responsible for the execution and reporting of all clinical trial activities, ensuring adherence to study timelines, budgets, Quality Plans, and applicable FDA/ICH/NIH guidelines.  The individual in this position will also be responsible for effective management of Clinical Contract Research Organization activities.

Key Responsibilities:

  • Writes and/or reviews protocols, protocol amendments, informed consent forms, annual reports, and regulatory submission documents.

  • Participates in interim reporting requirements to DSMBs.

  • Participates in the development of outsourcing strategies, including the selection of CRO’s and other external vendors, and the development of clinical trial budgets.

  • Manages clinical study activities at CROs.

  • Accountable for ensuring that all studies are carried out according to the study protocol, SOPs, applicable GCP/ICH guidelines.

  • Identifies and resolves problems, conflicts, and obstacles to the success of projects.

  • Participates in clinical operations process improvement initiatives to address clinical needs (e.g., development of investigator database, standardized CRF modules, etc.).




Success in this role will provide Uniquity with on time completion of all clinical studies while staying within budgetary guidelines.

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