Clinical Research Coordinator I (3932)

Dm Clinical Research Group; Phoenix (AZ); On-site; USD 52,000 - 75,000; Full time

Benefits offered by this job

None

Job summary

DM Clinical Research Group in Phoenix, AZ is seeking a Clinical Research Coordinator I to join our site and ensure high-quality data collection in line with sponsor protocols, FDA regulations, and ICH/GCP guidelines. You will help enrollment meet sponsor expectations and support timely company goals.

Responsibilities include completing required trainings, conducting visits, maintaining ALCOA-C records, data entry, and coordinating with staff, investigators and sponsors to facilitate smooth study

Qualifications

• 1+ years as a CRC, preferably coordinating industry-sponsored vaccines in private settings.
• 2+ years as a research assistant, data coordinator, or lab personnel in clinical research.
• ACRP certification preferred; Registered Medical Assistant preferred.

Responsibilities

• Complete all required training on a timely basis (ICH-GCP, IATA, protocol, EDC/IVRS).
• Conduct subject visits and document procedures per protocol and ALCOA-C standards.
• Enter data and resolve queries per guidelines and sponsor expectations.
• Liaise with laboratory, data, admin, investigators, staff and sponsor representatives.
• Assist with subject recruitment and retention and obtain informed consent.

Skills

Detail-oriented

Multitasking

Communication skills

Bilingual English/Spanish

Education

High School Diploma

Bachelor's degree

Foreign Medical Graduates preferred

Job description

Job Overview

Location: Phoenix, AZ 85012. The Clinical Research Coordinator I will 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

No additional qualifications listed.