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Clin RSCH Supv 1

Company: University of California
Location: Oakland
Posted on: June 10, 2021

Job Description:

Job Summary

The Department of Pediatrics is seeking a Clinical Research Supervisor/Protocol Project Manager for the Pediatric Hematology Program. Under the supervision of the Clinical Research Manager, the Clinical Research Supervisor/Protocol Project Manager is tasked with managing and facilitating the Pediatric Hematology program day-to-day operations of their direct reports including training and supervising a team of 2-4 clinical research coordinators (CRC). The Clinical Research Supervisor/Protocol Project Manager is responsible for training and evaluating CRC performance in executing studies, direct oversight of data collection and reporting, and implementation of protocols within the program that meet federal, state and institutional policies and guidelines. The Clinical Research Supervisor/Protocol Project Manager assists the Clinical Research Manager in resolving operational, workload, protocol implementation, and data collection issues. The candidate will be a proven team-player with project management skills and mindset and have the ability to consistently deliver results on a tight timeline.

The Clinical Research Supervisor/Protocol Project Manager will work with the Clinical Research Manager to develop standard operating procedures, and is responsible for training and mentoring CRCs to coordinate studies per Good Clinical Practice (GCP), with the goal to achieve optimal efficiency and productivity without jeopardizing patient care and data integrity. The individual will be a team player and assist with projects, patient coverage, and other CRC duties whenever necessary.

In addition to supervising clinical research coordinators, along with the Principal Investigator and Sponsor, the Clinical Research Supervisor/Protocol Project Manager will serve as the main point of contact between Principal Investigators (PIs) and Sponsors during study activation and maintenance. Specific duties related to study activation may include: completing pre-activation tasks such as feasibility surveys and assessment with study team; coordinating protocol reviews and submissions to Disease Site Committee and Protocol Review Committee; identifying ancillary committee approval with study team required by a protocol and initiate the process for review; and timely processing of new protocols through the activation pipeline including Medicare coverage analysis and budget sign off, informed consent approval and Institutional Review Board (IRB) submission, contract execution, and billing set up. Other duties may include, but will not be limited to: facilitate start-up and study coordination at external sites for multi-site investigator initiated studies; supporting the management and coordinating the tasks of single or multiple clinical research studies; coordinating study start-up; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; train CRCs, oversee study data integrity.

Required Qualifications

  • Bachelor's degree in related area and three or more years of experience including lead or supervisory experience, and/or equivalent experience/training
  • Clinical Trial Professional certification from a professional society within one year in position
  • Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting
  • Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research
  • Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities
  • Critical thinking skills to evaluate issues and identify a potential solution
  • Clear and concise communicator; good verbal and written communication skills; both
  • Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration
  • Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems

Note: Physical/health screening required.

Preferred Qualifications

n/a

Keywords: University of California, Oakland , Clin RSCH Supv 1, Other , Oakland, California

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