Clinical Research Coordinator

Paycom; Lafayette (LA); On-site; USD 42,000 - 66,000; Full time

Job summary

Paycom is initiating efforts to build a dedicated research department in Lafayette to oversee study recruitment, protocol evaluation, budgeting, and sponsor communications.

The role requires maintaining FDA/GCP/ICH knowledge, obtaining patient consent with high ethical standards, and coordinating with IRB, PIs, and sponsors. Proficiency with EMR/EDC/eCRFs and SOPs is essential.

Qualifications

• Experience in coordinating clinical studies and patient recruitment.
• Familiarity with FDA, GCP, ICH, HIPAA requirements.
• Ability to manage budgets, invoices, and site visits.

Responsibilities

• Assist with recruitment of studies and budget evaluation.
• Maintain certifications and knowledge of regulations.
• Obtain and maintain patient consent with high ethical standards.
• Lead or assist with staff training, delegation, and hiring.
• Screen patients, collect history, and perform exams as required.
• Work with EMR and data management systems (EDC/eCRFs).
• Prepare SOPs, NDAs, CVs, and certifications.
• Coordinate with IRB, sponsors, PIs, and sub-Is.
• Monitor budgets and invoicing; participate in audits and close-out steps.

Skills

Clinical research knowledge

IRB coordination

EMR/data management

GCP/ICH/FDA regulations

Informed consent

Education

Bachelor's degree in life sciences

Tools

EDC/eCRFs

EMR systems

Job description

Work to build the research department in scope, size, reputation, and professionalism. Research Coordinator 06.2020 • Assist with recruitment of studies, budget evaluation and negotiation, protocol evaluation, communication with study sponsors. • Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc. • Obtain and maintain consent of patients with the highest ethical standards. • Work with other research department staff in a leadership role including management, training, delegation of responsibilities, hiring, etc. • Work directly with patients to screen, consent, take history, complete necessary exams including EKG, blood draw, vitals, etc. • Communicate with and support patients and their families as necessary. • Work with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain records. • Must have or gain knowledge of relevant software/programs. • Have a basic and working knowledge of trial design, statistical methods, etc. • Triage, record, and report adverse events. Record and report any protocol deviations. • Work closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and calls. • Create and maintain department SOPs, NDAs, CVs, certifications, etc. • Evaluate, purchase, maintain necessary equipment. • Maintain HIPAA compliant communication and confidentiality, at all times. • Maintain study budgets and monitor invoicing, billing, and payments. • Participate in site visits, SIVs, monitoring, etc. • Complete necessary study close-out steps and documentation. • Assist with other duties assigned.