Clinical Research Scientist
The Clinical Research Scientist (CRS) will contribute to the design, data collection, data review and reporting of clinical studies. This position has a key role in support of clinical development.
The primary responsibilities for the CRS include:
• Contribute to authoring and design of study-related documents and deliverables, including but not limited to Clinical Protocols, Investigator Brochures, Study Manuals, Case Report Forms, Clinical Study Reports, Annual Reports, , regulatory submissions and abstracts.
• Review clinical data listings, patient profiles and summaries to ensure data collection proceeds in a manner consistent with the protocol and strategic objectives.
• Participate in review and management of safety reports and submissions
• Participate in clinical and safety database reconciliation
• Support project team with conduct of clinical studies, including review of informed consent forms, site contracts, data management deliverables, clinical monitoring activities, interim analyses planning and Data Safety Monitoring Board (DSMB) meetings.
• Assist the project team in the monitoring and analysis of emerging clinical data and safety data trends.
• Interact with internal and external stakeholders (Key Opinion Leaders, medical monitor, medical writers, vendors, committees) in support of clinical trial objectives and deliverables.
• Conduct literature reviews to support clinical development programs and regulatory submissions.
• Lead and manage investigator-initiated trials activities, including but not limited to leading committee reviews of research access proposals from investigators, executing site agreements, coordinating site training and managing necessary oversight
Education: A Masters degree, PharmD or PhD is required.
Experience: Candidates should have a minimum of 5 years experience in clinical research development.
• Medical writing and data management/analysis experience is a plus
• A minimum of 2 years oncology experience is required
• Must possess highly effective analytical, writing and communication skills
• The ideal candidate should also be well organized, detail oriented, and flexible
• Proficiency in MS Office Suite and have the ability to multi-task and work effectively in a team or independently on assigned tasks