Senior Clinical Research Coordinator - Cardiovascular

The Senior Clinical Research Coordinator -Cardiovascular  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. 

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:
  1. Sponsor-provided and IRB-approved Protocol Training
  2. All relevant Protocol Amendments Training
  3. Any study-specific Manuals Training, as applicable
  4. 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 the 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.
• Demonstrating adherence and compliance to the assigned protocols at their respective site(s).
• 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).
• Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)
• 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).
• 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.
• Completing data entry and query resolution in a timely manner as per internal company guidelines and asper sponsor expectations.
• 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
• 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 & EXPERIENCE

Education:

• High School Diploma or equivalent required; Bachelor's degree preferred
• Bachelor's degree, or a related health science discipline, or a Foreign Medical Graduate

• At least 4 - 5 years of experience as a Lead or Senior CRC, preferably with practice coordinating industry-sponsored studies in a private setting.

Credentials:

• ACRP or equivalent certification 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.