Job Description

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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