Clinical Research Coordinator I (4080)

Dm Clinical Research Group; Pennsylvania; On-site; USD 47,000 - 62,000; Full time

Job summary

Dm Clinical Research Group is seeking a Clinical Research Coordinator I to work at a Philadelphia site and ensure high-quality research in accordance with sponsor protocols, FDA regulations, and ICH/GCP guidelines. You will help meet enrollment targets and support timely, accurate data collection.

The role requires at least 1 year of CRC experience (vaccines preferred), strong communication skills in English, and the ability to multi-task and work with diverse teams.

Qualifications

• 1+ years of CRC experience, preferably with vaccines in a private setting.
• 2+ years as a research assistant or equivalent in a clinical research setting.
• ACRP or equivalent certification is preferred.
• Registered Medical Assistant certification or equivalent is preferred.

Responsibilities

• Complete all required training (ICH-GCP, IATA, protocol training) on a timely basis.
• Conduct study visits and perform protocol-required procedures with accurate documentation.
• Ensure ALCOA-C standards for clinical trial documentation.
• Perform data entry and resolve queries per guidelines and sponsor expectations.
• Coordinate with Lab, Data, Administrative, and Investigators teams for assigned protocols.
• Assist with subject recruitment and retention efforts; communicate with participants and address concerns.
• Explain study procedures and obtain informed consent; explain risks, benefits, and alternatives clearly.
• Facilitate communication between patients, healthcare providers, and research staff.

Skills

Detail-oriented

Multitasking

Communication skills

Bilingual English/Spanish

Education

High School Diploma or equivalent

Bachelor's degree preferred

Foreign Medical Graduates preferred

Job description

Job Details

Job Location: Philadelphia - Philadelphia, PA 19107

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