The Clinical Research Coordinator III works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for oversight of all studies with the group and the assignment of studies to clinical research personnel within the group, and supervision of research staff. Plans and coordinates strategies for increasing patient enrollment, improving efficiency, training of personnel, and identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Primary Duties and Responsibilities

• Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
• Scheduling of patients for research visits and procedures.
• In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
• Maintains accurate source documents related to all research procedures.
• Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
• Schedules and participates in monitoring and auditing activities.
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
• Notifies direct supervisor about concerns regarding data quality and study conduct.
• Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events,
• Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs.
• Works with Training and Education Coordinator to ensure all staff is properly trained and certified.
• Participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
• Plans and coordinates strategies for increasing patient enrollment, and/or improving clinical research efficiency.
• Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• Identifies new research opportunities and presents to investigators.
• Supervises other research staff.

Job Description Addendum

• Complete Site Feasibility Questionnaires and take on lead role in Pre-Study/Site Qualification Calls/Visits
• Demonstrate ability to train, guide and support study team staff as a subject matter expert, in study execution activities
• Develop or contribute to the development of tools, processes and training to enhance subject pre-screening and screening activities. May evaluate eligibility related job aids, worksheets and provide recommendations for improvements to enhance protocol compliance
• Evaluate study tools/plans and metrics to assess areas of non-compliance. Translate findings into the development of new tools, processes and training to enhance the quality of study conduct
• Create workflows and support study team members in developing workflows/processes across departments (outside the cancer center) for study logistics
  • Project management during study start up activities
  • Identify ancillary departments for inclusion in SIV
• Guide study team members in best practices for reporting of AE/SAEs and deviations in line with CSMC SOCCI CCTO reporting guidelines
• ACRP/SOCRA (or equivalent) certification required. Maintenance of certification (membership, dues, etc.) must remain current
• Train and mentor CRC Is and IIs. Demonstrate advanced skills and knowledge. Has the ability to teach, coach or supervise
• Review labor allocations to ensure appropriate effort tracking

Requirements:

• High School Diploma/GED
• 4 years Clinical research related experience
• 3 years involvement in coordination of clinical research trials

Preferred:

• Bachelor's Degree Science, Sociology or related degree
• Certification In Clinical Research SOCRA or ACRP certification

Physical Demands:

Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.

Working Title: Clinical Research Coordinator III (GI)
Department: SOCCI Clinical Research Office
Business Entity: Academic / Research
Job Category: Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$71,300.00 - $121,000.00