Clinical Research Coordinator III
The Clinical Research Coordinator III will ensure that quality research is conducted at 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. To 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 and overseeing 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 and overseeing 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, implementation and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols.
- Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives for assigned protocols.
- Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)
- Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s).
- Ability to train and mentor site staff, as needed
- Supervise visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)
- Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
- Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).
- Maintaining a working knowledge of Study Participants' Scheduling, Visit Tracking, Stipends and Transportation by liaising with the Administrative team.
- Maintaining a working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s)
- Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.
- Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
- Being prepared for and available at all required company meetings.
- Submitting required administrative paperwork per company timelines.
- Occasionally attending out-of-town Investigator Meetings
- Any other matters as assigned by management
KNOWLEDGE & EXPERIENCE
Education:
- High School Diploma or equivalent required
- Bachelor's degree preferred
- Foreign Medical Graduates preferred
Experience:
- Minimum of 5 years experience in Clinical Research
- Supervisory experience preferred
- Wide therapeutic range of clinical trials experience preferred
- Regulatory research experience is a plus
Credentials:
- ACRP or equivalent certification is preferred
Experience:
- Minimum of 5 years experience in Clinical Research
- Supervisory experience preferred
- Wide therapeutic range of clinical trials experience preferred
- Regulatory research experience is a plus
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