Clinical Research Coordinator I

Boston, MA
Full Time
Clinical Operations
Entry Level
Clinical Research Coordinator I

The CRC 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 ensure company goals are achieved 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:
    1. Sponsor-provided and IRB-approved Protocol Training
    2. All relevant Protocol Amendments Training
    3. Any study-specific Manuals Training, as applicable
    4. 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.
  • Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives 
  • Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent 
  • Facilitate effective communication between patients, healthcare providers, and research staff
  • Any other matters, as assigned by management.

KNOWLEDGE & EXPERIENCE
 

Education:

  • High School Diploma or equivalent required
  • Bachelor's degree a plus
  • Foreign Medical Graduates preferred 

Experience:

  • 1+ years of experience as a CRC,  preferably with practice coordinating industry-sponsored vaccines in a private setting.
  • 2+ 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.
  • Proficient communication and comprehension skills both verbal and written in the English language are required. 
  • Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.
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