CAREERS

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.).

 

Accomplishments:

 

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

​