Clinical Research Coordinator I

Paycom - ATS

Tomball (TX)

On-site

USD 52,000 - 66,000

Full time

7 days ago
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Job summary

Paycom - ATS is seeking a Clinical Research Coordinator I to support investigative sites, ensuring quality data per sponsor protocol, FDA, and ICH/GCP guidelines. The CRC I will help ensure study enrollment meets sponsor expectations and timelines.

The role includes patient recruitment, consent discussions, subject visits, data entry, and collaboration with sponsor/CRO teams. Strong English communication is required; bilingual English/Spanish is preferred, and training in ALCOA-C and ICH-GCP is

Qualifications

  • High School Diploma or equivalent required.
  • Bachelor's degree a plus.
  • ACRP or equivalent certification preferred.
  • Registered Medical Assistant certification or equivalent preferred.
  • 1+ year of CRC experience; 2+ years in related clinical research roles preferred.

Responsibilities

  • Completing required training (ICH-GCP, IATA) before study start and ongoing.
  • Conducting subject visits and protocol procedures with timely documentation.
  • Maintain ALCOA-C standards in study documentation and data handling.
  • Data entry and query resolution per sponsor guidelines and timelines.
  • Assist in participant recruitment/retention and conduct informed consent discussions.

Skills

Communication skills
Bilingual English/Spanish
Multitasking

Education

High School Diploma
Bachelor's degree

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.
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