Clinical Research Coordinator II

Paycom - ATS; Minnesota; On-site; USD 60,000 - 80,000; Full time

Job summary

Paycom - ATS is seeking a CRC II to conduct site visits, manage trial documentation, and ensure data integrity across sponsor protocols. The role emphasizes regulatory compliance, ALCOA-C standards, and teamwork with Lab, Data, and Clinical staff in Minnesota.

Responsibilities include informed consent, safety reporting, data entry, and site coordination to meet enrollment and quality targets in a fast-paced research environment.

Qualifications

• High School Diploma or equivalent required.
• Bachelor's degree preferred.
• ACRP certification or equivalent preferred.
• Strong written and verbal English communication.
• Bilingual English/Spanish preferred.

Responsibilities

• Conduct study subject visits and document procedures per protocol.
• Adhere to ALCOA-C standards in all trial documentation.
• Complete data entry and query resolution per guidelines and sponsor expectations.
• Liaise with Laboratory, Data, Administrative staff, Investigators, participants and Sponsor/CRO.
• Oversee reporting of Adverse Events and safety information as required.
• Obtain informed consent and explain study procedures, risks and benefits to participants.
• Support recruitment and retention activities at assigned sites.
• Prepare for sponsor/CRO and Investigator Meetings as needed.
• Attend investigator meetings as required.

Skills

Attention to detail

Multitasking

Proficient English communication

Bilingual English/Spanish preferred

Clinical research coordination

Education

High School Diploma or equivalent

Bachelor's degree preferred

ACRP certification preferred

Job description

The CRC II 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 II will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis.DUTIES & RESPONSIBILITIES1. 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 Trainingb. All relevant Protocol Amendments Trainingc. Any study-specific Manuals Training, as applicabled. 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 the 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. Demonstrating adherence and compliance to the assigned protocols at their respective site(s).10. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)11. Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s).12. Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)13. Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).14. Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.15. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.16. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).17. Being prepared for and available at all required company meetings.18. Submitting required administrative paperwork per company timelines.19. Occasionally attending out-of-town Investigator Meetings20. Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives21. Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent22. Facilitate effective communication between patients, healthcare providers, and research staff23. Any other matters as assigned by management.KNOWLEDGE & EXPERIENCEEducation:High School Diploma or equivalent required; Bachelor's degree preferredForeign Medical Graduates preferredExperience:At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.Credentials:ACRP or equivalent certification 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.