Job title: Clinical Research Coordinator I
Company: DM Clinical Research
Job description: Clinical Research Coordinator IThe 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:
- 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.
KNOWLEDGE & EXPERIENCEEducation:
- 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.
Powered by JazzHR
Expected salary:
Location: Detroit, MI
Job date: Wed, 07 Aug 2024 06:03:00 GMT
Apply for the job now!