Clinical Research Study Manager

Ideal candidate will have experience in the form of having worked as as CRA and have been in clinical research for at least 10 years. Salary based on experience.

Responsibilities

· With support from operational leadership, assesses team performance, manages distribution of staff workload, and ensures compliance amongst staff

· Supervises staff to include performance management and development, training, on-boarding

· May serve as a back-up and fill temporary portfolio management needs

· Works with clinical research leadership to ensure alignment between team needs and department infrastructure to facilitate strategic planning

· Provides oversight of the clinical research portfolio, including reviewing potential research opportunities with the Medical Director and Principal Investigators (PI) where needed to evaluate alignment with portfolio development goals, assists in the selection process, and opening of appropriate studies

· Supports the protocol feasibility review process

· Tracks team metrics where requested, and reports metrics to operational leaders on a regular basis

· Supports PIs and staff to ensure GCP and institutional compliance for all study protocols

· Ensures coordinators are adhering to GCP including confirmation of subject eligibility, proper informed consent process & documentation, and protocol adherence

· Performs quality oversight to include monitoring progress of screening, enrollment, and data submission

· Ensures compliance with department policies and procedures

· Identifies barriers to timely study activation, efficient coordination, and along with operational leadership identifies/implements potential solutions

· Ensures timeliness and accuracy of clinical research information and data in all databases and tracking systems

· Provides support in engaging relevant providers (physicians, advance practice providers, clinic nurses, staff) to ensure that clinical issues at all points of contact, are addressed in a timely and compliant fashion

· Assists with the development and implementation of departmental specific role-based curriculum for new employees

· Contributes to the development and refinement of standard operating procedures (SOPs) and assists with SOP training where requested

· Contributes to the development and execution of educational in-services pertinent to the performance of high-quality clinical research

· Contributes with operational leadership to the development of study-level corrective action plans, subsequent implementation, and documentation of progress of plans

· Actively participates in meetings, task forces and committees as assigned

· Promotes and advances the clinical research activities in a safe, compliant, effective, efficient, and collegial manner

· Other duties as assigned

· Building a culture of care, engagement, and recognition with clear outcomes

Summary

As a Clinical Research Study Manager, you will lead and oversee clinical trials, ensuring adherence to Good Clinical Practice and FDA regulations. Your core expertise in clinical research and data collection will be essential in managing study protocols and documentation review. With premium skills in supervising teams and patient monitoring, you will drive project success while maintaining compliance with industry standards. Your relevant experience in data management and EMR systems will further enhance the efficiency of research operations, making you a vital asset in advancing clinical development initiatives within our organization.

Job Type: Full-time

Pay: From $65,000.00 per year

Benefits:

• Health insurance
• Paid time off

Schedule:

• Monday to Friday

Work Location: In person

Salary : $65,000