Clinical Research Coordinator - 255355

Medix™; Toledo (OH); On-site; USD 45,000 - 65,000; Full time

Job summary

Medix is seeking a Clinical Research Coordinator in Toledo, Ohio to oversee participant care from screening through study completion. You will ensure proper informed consent and documentation per regulations, and coordinate data collection and study-related activities with the PI and clinical team.

The role requires at least 2 years in clinical research or a patient-facing research role and the ability to support multiple studies concurrently.

Qualifications

• Minimum 2 years in clinical research or a related field.
• Experience in patient-facing research roles or as MA/EMT/Phleb is preferred.
• Ability to support at least 3 studies simultaneously at Toledo location.

Responsibilities

• Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation.
• Ensure informed consent is properly obtained according to 45 CFR part 46.
• Report adverse events, protocol deviations and unanticipated problems to the PI, Sponsor, and IRB.

Skills

Clinical research

Patient facing

MA/EMT/Phleb experience

Multi-study support

Job description

• Coordinate all aspects of participant care from screening through study completion as defined by the
• protocol and PI delegation.
• Ensure and document that the informed consent process has occurred properly according to the Code of
• Federal Regulations (45 CFR part 46).
• Assist in the process of maintaining and updating each study participant’s source records, including
• collection of medical history, assessment of eligibility and documentation of all study related procedures
• and relevant information.
• Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human
• subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations
• (21 CFR 312), with assistance as applicable.
• Ensure thorough, individualized, protocol-based study subject education on all study processes including
• but not limited to informed consent, study participation obligations, appropriate use of investigational
• product (IP), IP side effects and safety, communication with study staff and research rights.
• Provide timely and accurate exchange of participant information with the PI and research team as it
• pertains to study conduct and patient safety.
• Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect
• participant confidentiality at all times.
• Dispense, administer and instruct participants on proper use of the investigational product (IP) in
• accordance with the protocol, coordinator’s scope of practice and at the direction of the PI, with
• assistance as needed.
• Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with
• the study protocol by our clinical partners, with assistance as needed.
• Perform accurate and timely data collection, source documentation, and entry into the USRC databases
• and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and
• sponsor requests in a timely manner.
• Aid in the coordination of long-term storage of research records in accordance with contractual
• requirements, with direction from the Director of Clinical Research.
• Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or
• regulatory authority inspections.
• Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate
• compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form
• FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional
• review board (IRB) related documents, IND reports delegation of authority (DOA), study specific
• enrollment logs, monitoring reports, with assistance as needed.
• Assists in the coordination of efforts of internal and external resources (industry partners, clinical research
• organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment
• goals and trial plan execution.
• Fosters a patient-care culture that emphasizes patient safety and quality in all aspects.
• Responsible for the patient stipend automated payment process including registration into the system and
• processing payments per the USRC policy and ongoing maintenance of payments during the trial.
• Adheres to the USRC Research quality assurance program guidelines.
• Travel to Investigator Meetings or similar research related meetings is required.
• Travel may be required between dialysis facilities or nephrology practices within the community.
• Develops a working knowledge of current clinical research practice standards and regulatory
• requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice
• (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation
• Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and
• certifications.
• May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.
• Actively promotes GUEST customer service standards; develop effective relationships at all levels of the
• organization.
• Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.
• Participate in staff meetings as required.
• Regular and reliable attendance is required for the job.

Required Skills

• 2 years min of CR
• Needs someone who has been in a patient facing research role or exp as a MA or EMT or Phleb
• Ability to support at least 3 studies at once. Studies are industry funded and IIT at Toledo location

Preferred Skills

• Nephrology

Schedule/Shift

Monday–Friday, 9AM–5PM. Occasionally may need to start early (5AM). Some metro travel to satellite locations within 10 miles