Clinical Research Coordinator FT Days - Shared Service Center at Forbes

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Clinical Research Coordinator Regulatory Medical Staff Full Time Days Position Summary

The primary responsibility of the Research Clinical/Regulatory Coordinator is to ensure the accurate progress of clinical trials from study initiation through study termination by serving as the primary liaison to the Physician Investigator, the patient, the hospital and the company or government sponsor. The Research Clinical/Regulatory Coordinator ensures that all study activity is in accordance with standard operating procedures, good clinical practice and instructions/specifications outlined in the research protocol. In addition, the Research Clinical/Regulatory Coordinator, in conjunction with Physician Investigators and colleagues, must develop and execute recruitment plans to meet patient accrual targets for each clinical trial. Lastly, the Research Clinical/Regulatory Coordinator must initiate and maintain excellent working relationships with internal and external customers (e.g., patients, study sponsors, Physician Investigators, hospital/office personnel) and ensure that the requirements of the company or government sponsor are met and maintained.

Responsibilities

• Identify, screen, randomized and enroll patients in IRB approved clinical trial protocols. Employee will spend the majority of his/her time in office setting, clinic and hospital patient care areas.
• Complete all study related procedures, clinic visits, etc. according to IRB approved protocol, Carondelet Standard Operating Procedures, Sponsor specifications and Good Clinical Practice. This includes direct patient care activities, such as informed consent, physical assessments, blood draws, medication administration, etc.
• Complete source documentation and case report forms according to IRB approved protocol, Carondelet Standard Operating Procedures, Sponsor specifications and Good Clinical Practice. Maintain regulatory documents and IRB correspondence according to Carondelet Standard Operating Procedures, Sponsor specifications and Good Clinical Practice.
• Complete and execute study logistics and feasibility plan for clinical trials as assigned. This includes in-servicing and/or educating hospital, office and ancillary service personnel with regards to clinical protocol. In addition, building and maintaining excellent communication with physician Investigators and others needed to conduct quality research and foster an excellent reputation of the Medical Staff Department is an essential component of the position.
• Maintain internal databases for clinical research according to Carondelet Standard Operating Procedures
• Participate in strategic planning and clinical operations meetings as needed. Deliverables will include: (1) working with other team members to develop a plan to ensure all study related procedures are completed, (2) develop a mechanism to provide after-hours coverage for research patients, (3) offer solutions for challenges identified, and, (4) provide recommendations for growth and development of the Medical Staff Department.
• Assist clinical research operations support team (finance, regulatory, quality, business development) in fostering the growth and development of the research division.
• Attend Investigator meetings and training sessions as needed. This may require out of town travel up to 6 times per year.
• Other related job tasks or responsibilities as assigned.

THE CLINICAL RESEARCH COORDINATOR REGULATORY MEDICAL STAFF FULL TIME DAYS CANDIDATE WILL POSSESS THE FOLLOWING EDUCATION, LICENSE/CERTIFICATIONS, AND EXPERIENCE

Education
Required: Bachelor’s Degree, or equivalent experience
Preferred: B.S.

Certificates
Required: Clinical Research Certification. Candidate must be willing to seek Certified Clinical Research Coordinator (CCRC) certification (requires 2 years full-time experience and successful completion of certification exam).
Preferred: Certification from The Association of Clinical Research Professionals (ACRP) and/or Society of Clinical Research Associates (SOCRA).

Experience
Required: Minimum of three (3) years in clinical research as a Research Coordinator.
Preferred: 3 years externally funded clinical research experience.

Skills
Required: Excellent communication skills, Entrepreneurial spirit. Solutions oriented and able to multi-task.

Technology
Required: Advanced computer skills

Supervisory
Required: Oversee Research Assistants

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Employment practices will not be influenced or affected by an applicant’s or employee’s race, color, religion, sex (including pregnancy), national origin, age, disability, genetic information, sexual orientation, gender identity or expression, veteran status or any other legally protected status. Tenet will make reasonable accommodations for qualified individuals with disabilities unless doing so would result in an undue hardship.