Clinical Research Coordinator I

Dm Clinical Research Group; Philadelphia (Philadelphia County); On-site; USD 55,000 - 75,000; Full time

Job summary

Dm Clinical Research Group is seeking a Clinical Research Coordinator I to work at the site to ensure quality research aligns with sponsor protocol, FDA regulations, and ICH/GCP guidelines, delivering high-quality data.

The role involves training, patient recruitment, consent discussions, data entry, ALCOA-C documentation, and coordinating with laboratories and sponsor teams to meet enrollment and study timelines.

Qualifications

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

Responsibilities

• Complete DMCR-required training, including ICH-GCP and IATA certifications.
• Conduct subject visits and protocol-required procedures; document timely.
• Data entry and query resolution per guidelines and sponsor expectations.
• Recruit and retain subjects; engage with participants and address concerns.
• Obtain informed consent and explain procedures, risks, benefits, and alternatives.
• Facilitate communication between patients, healthcare providers, and research staff.
• Submit administrative paperwork per timelines; liaise with teams and sponsor/CRO representatives.

Skills

Communication skills

English proficiency

Bilingual English/Spanish

Attention to detail

Data entry

Education

High School Diploma

Bachelor's degree preferred

Job description

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 & RESPONSIBILITIESCompleting 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 TrainingAll relevant Protocol Amendments TrainingAny study-specific Manuals Training, as applicableSponsor-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 alternativesProvide clear explanations of study protocols and ensure patients' understanding before obtaining their consentFacilitate effective communication between patients, healthcare providers, and research staffAny other matters, as assigned by management.KNOWLEDGE & EXPERIENCEEducation:High School Diploma or equivalent requiredBachelor's degree a plusForeign Medical Graduates preferredExperience: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 settingCredentials:ACRP or equivalent certification is preferredRegistered Medical Assistant certification or equivalent is preferredKnowledge 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.