Clinical Research Coordinator I (3073)

GENERAL JOB DESCRIPTION
The CRC I 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.
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
1. Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA
Certification on a timely basis.
2. 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:
a. Sponsor-provided and IRB-approved Protocol Training
b. All relevant Protocol Amendments Training
c. Any study-specific Manuals Training, as applicable
d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
3. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely
manner.
4. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.
5. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor
expectations.
6. Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
7. 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.
8. 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.
9. Submitting required administrative paperwork per company timelines.
10. Participating in subject recruitment and retention efforts.
11. Engaging with Research Participants and understanding their concerns.
12. Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
13. Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
14. Facilitate effective communication between patients, healthcare providers, and research staff
15. 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.

All employees of DM Clinical Research, In any capacity, are expected to:

• Always treat others with dignity and respect
• Always conduct themselves in an ethical manner
• Comply with all local, state, and Federal, including FDA, regulations pertaining to the conduct of clinical trials on human subjects
• Comply with departmental and company expectations, policies, and procedures at all times
• Report to work as scheduled and seek approval from your supervisor in advance for any changes to the established work schedule, including the use of leave and late or early arrival and departures.
• Perform assigned duties and responsibilities with the highest degree of trust.
• Protect patient privacy at all times by keeping discussion of names and medical conditions confined to private locations, out of earshot of anyone not employed by DMCR.
• Be polite, upbeat, and professional, on the phone and in person.
• Maintain a high level of professionalism with CRAs and any Sponsor or CRO employee or representative