Clinical Research Coordinator II Job at DM Clinical Research, Humble, TX

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  • DM Clinical Research
  • Humble, TX

Job Description

Clinic Research Coordinator II

 
The  Clinical Research Coordinator II , 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:
    • 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
  • Bachelor's degree a plus
  • 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.
  • Bilingual in Spanish is preferred

Job Tags

Full time,

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