Clinical Research Coordinator

The Minneapolis Clinic of Neurology is seeking a Clinical Research Coordinator for a part-time, on-call research position for 5-10 hours per month. This position will work directly with patients under the direction of the Principal Investigator who is primarily responsible for the overall design and management of the trial.

This position requires the individual to be onsite at the office in Golden Valley, Minnesota periodically as dictated by the study.

Key Responsibilities:

Perform pre-study duties necessary to start a clinical trial.

• Understand the purpose, safety, confidentiality, benefits, and risks of clinical research trials.
• Assess protocol for site operational feasibility and advise on site budgetary requirements.
• Prepare for and conduct pre-study (site selection) and initiation visits.
• Coordinate investigational staff and other disciplines (MRI, EKG, Lab, etc.) involved in studies.
• Complete and submit the required regulatory documents to the IRB.
• Maintain verbal and written communication with Institutional Review Boards.
• Communicate study protocols to relevant hospital staff.
• Develop and complete documentation in compliance with research protocol.
• Screen and recruit patients for clinical research trials.

Manage multiple ongoing clinical trials.

• Assure adherence to study-specific requirements.
• Organize receipt, storage and return of study supplies, including study drug, and maintain accurate accountability logs as appropriate.
• Schedule and conduct patient appointments as required by research protocol.
• Obtain medical status, including histories, from potential and current study patients as appropriate.
• Abstract relevant study information from patients' medical records.
• Obtain and document patients' blood pressure, weight and height.
• Perform clinical laboratory services as required by the research protocol.
• Report abnormal laboratory results to the Principal Investigator.
• Develop, complete, and collect documentation in compliance with research protocol.
• Coordinate investigational staff and other disciplines (e.g. MRI, EKG, Lab) involved in studies.
• Provide education to patients under physicians' direction and assure his/her understanding.
• Complete and submit the required regulatory documents and emergent serious medical events to the IRB under direction of Principal Investigator.
• Meet with study monitors and assure query resolution as necessary or requested.
• Assure financial reconciliation against contract, including timely and accurate payment to staff and/or study subjects.
• Monitor study information and documentation for accuracy and perform the necessary corrections.
• Prepare study site for audits and inspections from the sponsor and/or FDA and respond to any findings.
• Clean and maintain exam and laboratory rooms used for patient visits.
• Monitor temperatures and equipment calibration for quality control purposes.

Close out clinical trials.

• Assure query resolution as necessary on requested.
• Prepare for and conduct study closeout visits.
• Prepare study site for audits and inspections from the sponsor and/or FDA and respond to any findings.

Assist physician and/or Clinic Manager with administrative support or clinical duties, as requested.

• Room patients for appointments, as needed.
• Assist physician with phone calls to patients, as requested.
• Participate in practice improvements by implementing changes to procedures/workflows, identifying opportunities for improvement, and assisting with the delivery of compassionate and personalized patient care.

Education and Experience:

• Bachelor's degree in biology, chemistry, psychology or other health-related field, or equivalent education and experience
• Minimum of two years of direct clinical research coordinator experience in a clinical setting, experience working in pharmaceutical clinical trials
• Current CCRC certification (SoCRA or ACRP), Medidata
• Current certification in Good Clinical Practices (GCP)
• Phlebotomy experience with processing of lab samples desired

Knowledge, Skills, and Abilities:

• Working knowledge of medical terminology required
• Knowledge of clinical research compliance standards, e.g. informed consent process, adverse event reporting, the Federal Code of Regulations and Good Clinical Practice Standards
• Knowledge of prescription medications and interactions desired
• Proficiency with MS Office, including Word, Excel and Outlook. Experience working with databases.
• Excellent interpersonal and communication skills, both verbal and written.
• Patient centered, strong customer service orientation.
• Detail oriented and able to be professional in a dynamic environment
• Ability to handle multiple priorities and deadlines and troubleshoot and resolve problems.
• Ability to work independently, exhibit mature judgment and make sound decisions.
• Ability to handle confidential information with the utmost judgment and discretion