Clinical Research Coordinator I

DM Clinical Research; Boston (MA); On-site; USD 50,000 - 65,000; Full time

Job summary

A clinical research organization is seeking a Clinical Research Coordinator I in Boston, MA. In this role, you will ensure quality research at investigative sites by adhering to sponsor protocols and FDA regulations. Responsibilities include conducting subject visits, maintaining clinical documentation, and engaging with research participants. Ideal candidates will have a high school diploma and at least one year of CRC experience, along with a detailed-oriented approach and strong multi-tasking skills.

Qualifications

• At least one year of experience as a CRC, preferably with industry-sponsored vaccines.
• At least two years in a clinical research setting as a research assistant or equivalent.

Responsibilities

• Conduct study subject visits and required procedures.
• Complete data entry and query resolution as per guidelines.
• Engage with Research Participants and understand their concerns.

Skills

Detail-oriented

Multi-tasking

Goals-driven

Education

High School Diploma or equivalent

Foreign Medical Graduates

Job description

Position: Clinical Research Coordinator I

Location: Boston, MA

Job Id: 1029

# of Openings: 1

The Clinical Research Coordinator I, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations to achieve company goals on a timely basis.

Duties & Responsibilities

• Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
• Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:
  • a. Sponsor-provided and IRB-approved Protocol Training
  • b. All relevant Protocol Amendments Training
  • c. Any study-specific Manuals Training, as applicable
  • d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
• Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
• Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.
• Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
• Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
• Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols.
• Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols.
• Submitting required administrative paperwork per company timelines.
• Participating in subject recruitment and retention efforts.
• Engaging with Research Participants and understanding their concerns.
• Any other matters, as assigned by management.

Knowledge & Experience

Education

• High School Diploma or equivalent required
• Foreign Medical Graduates preferred

Experience

• At least one years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.
• At least two years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting

Credentials

• ACRP or equivalent certification is preferred
• Registered Medical Assistant certification or equivalent is preferred
• Knowledge and Skills:
  • Be an energetic, go-getter who is detail-oriented and can multi-task.
  • Be goals-driven while continuously maintaining quality.