Clinical Research Coordinator

Job Details

Job Location:

Tomball 13406 - Tomball, TX 77375

The Clinical Research Coordinator I will work at site to help 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.

• 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:
  • Sponsor‑provided and IRB‑approved Protocol Training
  • All relevant Protocol Amendments Training
  • Any study‑specific Manuals Training, as applicable
  • 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.

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

• 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.

• ACRP or equivalent certification is preferred
• Registered Medical Assistant certification or equivalent is preferred.

• 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.