Clinical Research Coordinator - 256801

Medix™; Orange (CT); On-site; USD 55,000 - 80,000; Full time

Job summary

Medix is seeking a Clinical Research Coordinator to support investigational drug studies in Connecticut. You will coordinate participant care from screening to completion, ensure proper informed consent, and maintain source records with strict adherence to GCP and HIPAA standards.

The role requires 3+ years of CRC experience in patient-facing research, with the ability to manage at least three studies concurrently, and collaboration with USRC teams to ensure protocol compliance and data

Qualifications

• 3 years minimum as CRC supporting investigational drug studies.
• Experience in patient-facing research roles (MA/EMT/Phleb) preferred.
• Ability to support at least 3 studies concurrently.

Responsibilities

• Coordinate all aspects of participant care from screening through study completion.
• Ensure informed consent is documented per 45 CFR part 46.
• Maintain and update source records and eligibility documentation.
• Report adverse events and deviations to PI, Sponsor, and IRB per 21 CFR 312.
• Educate participants on protocol, IP use, safety, and rights.
• Exchange participant information with PI and research team for safety.
• Protect participant confidentiality per HIPAA.
• Dispense and instruct on IP use per protocol and PI delegation.
• Collaborate with USRC clinical team to ensure protocol compliance.
• Data collection and entry into USRC databases and CRFs/IWRS.
• Assist in long-term storage of records per requirements.
• Prepare for site initiation meetings, monitoring, audits.
• Maintain and update Trial Master File documents (FDA forms etc).
• Coordinate internal/external resources for recruitment and enrollment goals.
• Promote patient-care culture focused on safety and quality.
• Attend staff meetings and maintain reliable attendance.

Skills

CRC experience

Patient-facing role

Multiple studies

GCP familiarity

Tools

IWRS

GCP knowledge

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

• 3 years min of CR as a CRC supporting investigational drug studies
• 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

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