Job Description
The Foreign Medical Graduate (FMG) will take on our Clinical Research Coordinator III role in New Jersey. The FMC 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 at our site located in New Jersey. 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
Knowledge and Skills
Goals-driven while continuously maintaining quality.
Must be detailed-oriented, proactive, and able to take initiative.
Must have strong written and communication skills.
Must have excellent customer service skills.
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