Clinical Research Coordinator I (3073)

Dm Clinical Research Group; Bradenton (FL); On-site; USD 42,000 - 62,000; Full time

Job summary

DM Clinical Research Group is seeking a Clinical Research Coordinator I to work at site locations in Bradenton, FL. You will assist with study visits, data collection, and regulatory documentation to ensure protocol compliance and data quality.

The role requires strong communication, attention to detail, and the ability to multi-task across training, scheduling, and coordination with different teams. Knowledge of FDA regulations and GCP is beneficial.

Qualifications

• Minimum 1+ years of CRC experience (clinic/site) preferred.
• Strong communication and organizational skills are required.
• Bilingual abilities (English/Spanish) are preferred.
• Candidates should be able to coordinate at multiple sites and manage documentation.

Responsibilities

• Conduct patient visits and data collection per protocol.
• Ensure ALCOA-C compliant documentation and timely data entry.
• Coordinate with Laboratory, Data, and Administrative teams.
• Maintain regulatory and training certifications up to date.

Skills

Communication skills

Bilingual (English/Spanish)

Detail-oriented

Multi-tasking

Education

High School Diploma or equivalent

Bachelor’s degree a plus

Foreign Medical Graduates preferred

Job description

Job Details

Job Location: Bradenton - Bradenton, FL 34209TheClinical 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.