Clinical Research Coordinator

SMARTFOX; California; In loco; USD 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

SMARTFOX invites a Clinical Research Coordinator to support Phase I–IV trials across multiple therapeutic areas in the United States. You will screen and recruit participants, obtain informed consent, and coordinate study visits with data collection and regulatory compliance.

Responsibilities include data entry in Medidata Rave and other EDC platforms, maintaining trial binders, IRB submissions, and AE reporting. Requires a bachelor’s degree and US work authorization.

Competenze

• Bachelor’s degree or equivalent healthcare/research experience.
• Working knowledge of medical terminology and interest in clinical research.
• Hands-on experience from a job, internship, volunteer role, lab, or clinical setting.
• Exceptional attention to detail and habit of documenting everything accurately.

Mansioni

• Coordinate Phase I–IV clinical trials from start-up through close-out.
• Screen, recruit, and enroll participants and lead informed consent.
• Schedule and conduct study visits, collect vitals, specimens and questionnaires.
• Enter data into EDC systems accurately and on time and resolve queries quickly.
• Maintain regulatory binders and essential documents in line with ICH-GCP and 21 CFR rules.
• Prepare and submit IRB applications, amendments, continuing reviews, and safety reports.
• Identify, document, and report adverse events and serious adverse events.
• Coordinate investigational product accountability with the pharmacy team.
• Work with PIs, sub-investigators, nurses, pharmacists, and labs to ensure protocol compliance.
• Host monitoring visits, sponsor audits, and FDA inspections with solid corrective actions.

Conoscenze

Medical terminology

Clinical research coordination

Regulatory knowledge

Attention to detail

Clear communication

Multi-study management

Formazione

Bachelor’s degree in life sciences, nursing, public health, or related field

Strumenti

EDC systems familiarity

Descrizione del lavoro

• 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 with clarity, patience, and respect
• Schedule and conduct study visits, collecting vitals, specimens, questionnaires, and other protocol-required procedures
• Enter data into EDC systems (Medidata Rave, Oracle Clinical One, REDCap, Veeva, or similar) 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 each study protocol-compliant
• Host monitoring visits, sponsor audits, and FDA inspections with confidence, and close out findings with solid corrective actions
• Support study budgets, participant payments, billing compliance (coverage analysis), 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, always with human verification of every record

Find your fit :-

• Level - Typical experience - What you’ll own
• Clinical Research Coordinator I - 0-2 years : Supporting a portfolio of studies, running visits, entering data, maintaining binders, and learning GCP and protocol management with a dedicated mentor
• Clinical Research Coordinator II - 2-5 years : Independently managing multiple studies, leading start-up and recruitment, handling IRB and sponsor communication, and training new coordinators
• Senior / Lead CRC - 5+ years : Managing complex or high-enrollment trials, overseeing audit readiness, mentoring the team, improving SOPs, and partnering with PIs and leadership on new study opportunities

Promotion criteria are written down at every level, with regular career conversations. Many of our coordinators have moved into research manager, CRA, project management, regulatory affairs, and clinical operations roles.

What you bring

Must have :-

• Bachelor’s degree in life sciences, nursing, public health, or a related field, or equivalent healthcare or research experience (Associate degree plus relevant experience considered)
• Working knowledge of medical terminology and a genuine interest in clinical research
• Hands-on experience from a job, internship, volunteer role, lab, or clinical setting
• Exceptional attention to detail and a habit of documenting everything accurately
• Warm, clear communication with participants, families, and care teams
• Ability to juggle multiple studies, deadlines, and priorities calmly
• Authorization to work in the United States

Nice to have (not required) :-

• ACRP (CCRC) or SOCRA (CCRP) certification (we’ll pay for exam and renewal fees)
• CITI Program or GCP training, which we can also provide
• Phlebotomy, EKG, or vital signs certification, or clinical licensure (RN, LPN, MA, EMT)
• Experience with EDC, CTMS, or eRegulatory systems
• Prior work in oncology, vaccine, pediatric, or rare disease trials
• Experience with IRB submissions, FDA audits, or sponsor monitoring visits
• Familiarity with Epic or other EHRs for research workflows
• Bilingual (Spanish or other), a big plus for participant recruitment
• Willingness to travel between sites or support decentralized and home-visit trials [if applicable]