Clinical Research Coordinator I (4077)

Dm Clinical Research Group; Florida; On-site; USD 42,000 - 56,000; Full time

Job summary

Dm Clinical Research Group in Doral, FL is seeking a Clinical Research Coordinator I to support at-site coordination of clinical trials, ensuring adherence to sponsor protocols, FDA regulations, and ICH/GCP guidelines. The CRC I will assist with patient visits, informed consent discussions, data entry and timely documentation to deliver quality data for sponsors.

The role requires strong English communication, attention to detail, and the ability to multi-task across study activities.

Qualifications

• High School Diploma or equivalent required.
• Bachelor's degree a plus.
• ACRP certification preferred.
• Registered Medical Assistant certification or equivalent preferred.

Responsibilities

• Conduct patient visits and study procedures per protocol.
• Ensure adherence to ALCOA-C standards for documentation.
• Complete data entry and resolve queries per sponsor expectations.
• Coordinate with Laboratory, Data, Administrative staff and investigators.
• Assist with subject recruitment and retention efforts.
• Obtain informed consent and explain risks/benefits to participants.
• Communicate effectively with patients, providers and staff.
• Submit administrative paperwork within timelines.

Skills

Detail oriented

Multi-tasking

Communication skills

English proficiency

Bi-lingual English/Spanish

Education

High School Diploma or equivalent

Bachelor's degree preferred

Foreign Medical Graduates preferred

Job description

Job DetailsJob Location: Doral, FL - Doral, FL 33161TheClinical Research Coordinator Iwill work at site to help 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 & EXPERIENCE

Education:

• 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.

Qualifications