Research Coordinator Jobs

About The Position

Requirements

• High School Diploma or equivalent required
• Minimum of 5 years experience in Clinical Research
• 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.
• Proficient communication and comprehension skills both verbal and written in the English language are required.

Nice To Haves

• Bachelor's degree preferred
• Foreign Medical Graduates preferred
• Supervisory experience preferred
• Wide therapeutic range of clinical trials experience preferred
• Regulatory research experience is a plus
• ACRP or equivalent certification is preferred
• Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.

Responsibilities

• Completing all DMCR-required training, including ICH-GCP Certification and IATA Certification.
• Completing all relevant training prior to study-start and on a continued basis, including sponsor-provided and IRB-approved Protocol Training, Protocol Amendments Training, study-specific Manuals Training, and Sponsor-specified EDC and/or IVRS and 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.
• Adhering to ALCOA-C Standards with all relevant clinical trial documentation.
• Completing and overseeing data entry and query resolution in a timely manner as per internal company guidelines and sponsor expectations.
• Demonstrating appropriate and timely follow-up on action items at respective sites.
• Demonstrating 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 organizational SOPs, all guidance documents, and assigned study protocol(s).
• Maintaining a working knowledge of the recruitment and retention process for assigned protocols at respective sites.
• Training and mentoring site staff, as needed.
• Supervising visit preparedness for all relevant sponsor and CRO visits for assigned protocols.
• Maintaining a working knowledge of the most recent versions of Study Protocols, Informed consents, Study Manuals, and all other relevant study-related documents.
• Maintaining a working knowledge of Study Participants’ Scheduling, Visit Tracking, Stipends, and Transportation by liaising with the Administrative team.
• Maintaining a working knowledge of Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for assigned protocols.
• Overseeing 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 assigned protocols at respective sites.
• Being prepared for and available at all required company meetings.
• Submitting required administrative paperwork per company timelines.
• Occasionally attending out-of-town Investigator Meetings.
• Conducting patient consent discussions and ensuring comprehension of medical procedures, risks, benefits, and alternatives.
• Providing clear explanations of study protocols and ensuring patients' understanding before obtaining their consent.
• Facilitating effective communication between patients, healthcare providers, and research staff.
• Performing any other matters as assigned by management.