Job Description

Description

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 and EKG services as required by the research protocol.
• Report abnormal laboratory and EKG 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 Site 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.

Requirements

This is a full-time onsite position based in the Twin Cities area requiring a minimum of one year of clinical trial or clinical research experience. Remote or relocation support is not available for this role.

Education and Experience:

• Bachelor's degree in biology, chemistry, psychology or other health-related field, or equivalent education and experience
• Experience administering EKG tests desired
• Phlebotomy experience with processing of lab samples desired

Knowledge, Skills, and Abilities:

The ideal candidate should have prior experience working in a clinical research environment with a strong understanding of clinical trial workflows, patient-centered care, and research compliance. Candidates should possess excellent organizational, communication, and multitasking skills, with the ability to manage competing priorities in a fast-paced setting. Experience with study coordination, patient scheduling, source documentation, data entry, regulatory documentation, informed consent processes, specimen handling, or sponsor/CRO interactions is preferred. The candidate should demonstrate professionalism, attention to detail, adaptability, and a willingness to learn and contribute within a collaborative research team environment. Experience in neurology or neurological clinical trials is a plus.

Job Tags

Similar Jobs