Position Summary:

Rutgers, the State University of New Jersey is seeking a motivated Clinical Research Coordinator Supervisor for the Department of Medicine within the New Jersey Medical School.

The Clinical Research Coordinator (CRC) is a senior research professional working with and under the direction of the clinical Principal Investigators (PIs) within the Division of Gastroenterology and Hepatology. The CRC supports, facilitates and coordinates the daily clinical trial program activities, supervises clinical research staff, and plays a critical role in the conduct of the studies within the Division. By performing these duties, the CRC works with the Division Director, PI's, Division research staff, Department, Sponsor, and University to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies under the Division's clinical trial program.

Among the key duties of this position are the following:

• Coordinates with Principal Investigator and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with federal regulations and University and sponsoring agency policies and procedures.
• Supervises and manages the Division of Gastroenterology and Hepatology Clinical Research Program and clinical research staff, including research coordinators, data entry clerk, patient navigator and other clinical research staff.
• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
• Assists Principal Investigator to ensure that all key personnel or persons 'engaged' in the research projects have met training requirements in accordance with federal regulations and University and sponsoring agency policies and procedures.
• Cooperates with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors.
• Collaborates with PI and institution to respond to any audit findings and implement approved recommendations.
• Cooperates with University and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.
• Collaborates with the PI and department to prepare a categorized budget and justification. Confirms accuracy and completeness of budgeted costs.
  Collaborates with the PI to prepare IRB and any other regulatory submission documents as required by the protocol.
• Prepares study materials, as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Reviews and develops a familiarity with the contract or award terms and conditions. Works with the PI to ensure that the study is in compliance with all terms and conditions, including but not limited to education, IRB approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions.
• Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.

Minimum Education and Experience:

• Bachelor's degree required in healthcare, healthcare administration or other related field.
• Minimum of 5 years clinical research coordinator experience.
• At least 2 years of clinical research staff supervisory experience.

Required Knowledge, Skills, and Abilities:

• Working knowledge of regulatory requirements and Good Clinical Practices (GCP) experience.
• The ideal candidate will possess excellent interpersonal, oral and written communication skills, strong organizational and administrative skills and be detail oriented. Solid computer skills (Microsoft Word and Excel) is essential.
• Able to function independently and work flexible hours as needed to accomplish patient needs.

Preferred Qualifications:

• MPH or related master's degree.
• Either RN or LPN.
• Academic medical clinical research experience.
• Association of Clinical Research Professional (ACRP) certification as a Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) or Society of Clinical Research Associates (SoCRA) certification as a Clinical Research Professional (CCRP).

Physical Demands and Work Environment:

• Must be able to lift or exert force up to ten (10) pounds.

Salary: $75,875.00 Annually

Posting Number: 20ST1666

Location: Newark (RBHS)