Work Location
Orange, California

Work Shift
Day - 08hrs (United States of America)

Job Summary
The Clinical Research Coordinator Supervisor (CRC-Su) functions independently and is responsible for the complete coordination of multiple assigned human subjects' (clinical) research projects and is expected to perform all core Clinical Research Coordinator (CRC) responsibilities. The Supervisor serves as a mentor, an educator, and a leader with first-line supervisory oversight (e.g., involved with hiring, reviewing, and terminating other associates). Study management includes but is not limited to assessing feasibility of clinical research protocols, preparing materials needed for regulatory review and submission to the Institutional Review Board (IRB), identifying potential study participants, coordinating and collecting research data/specimens, completing study records in an accurate and timely manner, participating in quality assurance audits, managing study materials and supplies, communicating across multiple teams, and archiving records in accordance with appropriate policies and procedures. The Supervisor will be responsible for financial components of clinical research projects, documentation of investigator product (drug or device), development of source documents and/or case report forms and running research/project team meetings. In this role, the Supervisor may support investigator-initiated Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications, monitor or audit studies in the Research Institute, educate and mentor clinical staff, research team members, and other coordinators, and may be requested to coordinate multi-center studies. The Supervisor is responsible for evaluating CRC performance and assists the Site Manager in resolving operations workload, protocol implementation, and data collection issues. The Supervisor may also participate in one or more workgroups or committees within the Research Institute with a focus on CRC operations. The Supervisor is the most senior position in the Clinical Research Coordinator series.

Pay Range
Minimum $90,563 Midpoint $120,016 Maximum $149,427

Rate of pay is determined by various factors, including but not limited to knowledge, skills, competencies, experience, education, as well as position requirements.

Experience

Required: Minimum six (6) years of clinical research coordination experience.

Preferred: Clinical research experience in a hospital setting and/or pediatric clinical research experience and demonstrated leadership experience.

Education

Required: Bachelor's degree or equivalent additional experience can be accepted in lieu of education.

Preferred: Master's degree in a relevant field.

Specialized Skills

Required: Working knowledge of key Microsoft Office programs (Word, Excel, PowerPoint). Demonstrate strong interpersonal skills. Able to communicate effectively both orally and in writing. Be detail oriented. Able to work under pressure in a fast-paced environment while managing multiple competing priorities. Working knowledge of human subjects' regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for Good Clinical Practice (ICH-GCP). Ability to conduct informed consent. Strong knowledge of research sample identification, processing, and storage. Ability to manage conflict and to create a culture of accountability within their assigned team. Demonstrate good time and priority management and is capable of problem-solving.

Preferred: Working knowledge of Cerner or equivalent electronic medical record system.

Licensure

Required: Basic Life Support (BLS) - American Heart Association. If incumbent does not have certification at time of hire or promotion, certification is expected to be obtained within 6 months of assuming position. With management approval, the time in which to obtain certification may be extended past 6 months due to extenuating circumstances. Association of Clinical Research Professionals Certified Professional (ACRP-CP), Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) - If incumbent does not have certification at time of hire or promotion, certification is expected to be obtained within 12 months of assuming position. With management approval, the time in which to obtain certification may be extended past 12 months due to extenuating circumstances.

Preferred: Phlebotomy certification.

Work Environments - Functional Demand:
Light - Moderate energy level Lift and carry 25-35 lbs. Push/pull 50-100 lbs. (ie. empty bed, stretcher).

Physical Activity Requirements:
Bending, Carry Objects, Climbing, Keyboard use/repetitive motion, Pinching/fine motor activities, Push/Pull, Reaching forward, Reaching overhead, Sitting, Squat/kneel/crawl (Squad & Knee), Standing, Talk or hear, Taste or smell, Twisting, Walking, Wrist position deviation

Physical Activity Lifting
Lifting (Floor to waist level) - Constant 67 or more%, Lifting (Floor to waist level) - Frequent 36-66%, Lifting (Floor to waist level) - Occasional 0-35%, Lifting (Waist level and above) - Constant 67 or more%, Lifting (Waist level and above) - Frequent 36-66%, Lifting (Waist level and above) - Occasional 0-35%

Sensory Requirements:
Color Discrimination, Depth Perception, Far Vision, Hearing, Near Vision

Environment Requirements:
Airborn Communicable Disease, Bloodborne Pathogens, Chemical, Dust Particular Matter, Extreme Noise Levels, Extreme Temperatures, Radiation, Uneven Surfaces or Elevations