Clinical Research Coordinator

About the Role

SMARTFOX is seeking a Clinical Research Coordinator to support various clinical trials.

Key Responsibilities

• Coordinate Phase I-IV clinical trials from start-up through close-out, across oncology, cardiology, neurology, endocrinology, rare disease, vaccines, or other therapeutic areas.
• Screen, recruit, and enroll participants, and lead the informed consent process.
• Schedule and conduct study visits, collecting vitals, specimens, questionnaires, and other protocol-required procedures.
• Enter data into EDC systems (e.g., Medidata Rave, Oracle Clinical One, REDCap, Veeva) accurately and on time, and resolve queries quickly.
• Maintain regulatory binders and essential documents, including delegation logs, training records, 1572s, and CVs, in line with ICH-GCP, 21 CFR Parts 11, 50, 56, and 312, and the Common Rule.
• Prepare and submit IRB applications, amendments, continuing reviews, and safety reports.
• Identify, document, and report adverse events and serious adverse events (AEs/SAEs) according to protocol and regulatory timelines.
• Manage investigational product accountability, storage, and temperature logs with the pharmacy team.
• Work with PIs, sub-investigators, nurses, pharmacists, and labs to keep study protocols compliant.
• Host monitoring visits, sponsor audits, and FDA inspections, and close out findings.
• Support study budgets, participant payments, billing compliance, and invoicing.
• Keep participants engaged and retained, including those from underrepresented communities, through outreach and flexible scheduling.
• Use CTMS, eRegulatory, and eConsent tools, plus AI-assisted tools for screening and document review, with human verification.

Experience Levels & Ownership

• Clinical Research Coordinator I (0-2 years): Supporting studies, running visits, data entry, maintaining binders, learning GCP and protocol management.
• Clinical Research Coordinator II (2-5 years): Independently managing multiple studies, leading start-up and recruitment, handling IRB and sponsor communication, training new coordinators.
• Senior / Lead CRC (5+ years): Managing complex trials, overseeing audit readiness, mentoring the team, improving SOPs, partnering with PIs and leadership on new study opportunities.

Requirements & Tech Stack

• Bachelor’s degree in life sciences, nursing, public health, or a related field, or equivalent healthcare or research experience.
• Working knowledge of medical terminology.
• Hands-on experience from a job, internship, volunteer role, lab, or clinical setting.
• Exceptional attention to detail and accuracy in documentation.
• Clear communication with participants, families, and care teams.
• Ability to manage multiple studies, deadlines, and priorities calmly.
• Authorization to work in the United States.
• Experience with EDC, CTMS, or eRegulatory systems (nice to have).
• Familiarity with Epic or other EHRs for research workflows (nice to have).

Qualifications

• ACRP (CCRC) or SOCRA (CCRP) certification (certification exam and renewal fees will be paid).
• CITI Program or GCP training (training can be provided).
• Phlebotomy, EKG, or vital signs certification, or clinical licensure (RN, LPN, MA, EMT).
• Prior work in oncology, vaccine, pediatric, or rare disease trials (nice to have).
• Experience with IRB submissions, FDA audits, or sponsor monitoring visits (nice to have).
• Bilingual (Spanish or other) (a plus for participant recruitment).
• Willingness to travel between sites or support decentralized and home-visit trials (if applicable).