Clinical Research Coordinator

Job Description

Job Description

Salary: $26-$30

About the Role

We're a growing clinical research site network running concurrent industry-sponsored trials across cardiology, metabolic, and vascular indications. This is a hands-on, high-ownership role for a coordinator who thrives on variety. You won't be siloed into one protocol or one function on any given day you may be pre-screening patients, running a study visit, entering EDC data, prepping for a monitor visit, and updating regulatory binders. If you want a desk job, this isn't it. If you want to grow fast and touch every part of the trial lifecycle, keep reading.

What You'll Own

Patient Recruitment & Pre-Screening

• Mine EMR and referral lists against protocol I/E criteria
• Conduct telephone pre-screens using study-specific scripts
• Maintain pre-screen tracking across the active study portfolio
• Coordinate with the PI and sub-investigators on patient referrals
• Support outreach campaigns (mailers, community events, partner clinic touchpoints)

Clinical Visit Execution

• Obtain and document informed consent
• Conduct study visits per protocol: vitals, ECGs, study-specific assessments, sample collection
• Administer or dispense investigational product per protocol
• Identify and report AEs/SAEs to the PI; support causality and severity assessment
• Educate patients on study requirements, visit schedules, and IP compliance

Data Management

• Maintain accurate, ALCOA-compliant source documentation
• Enter data into sponsor EDC platforms (CRIO, Medidata Rave, Veeva, etc.) within sponsor timelines
• Resolve queries and support SDV during monitoring visits
• Reconcile labs, IP accountability, and ECG/imaging transmittals

Regulatory & Compliance

• Maintain ISF in audit-ready condition
• Draft Notes to File, protocol deviation documentation, and DoA updates
• Support IRB submissions, amendments, and continuing reviews
• Adhere to GCP, ICH, FDA, and HIPAA standards at all times

Cross-Protocol Coordination

• Manage your assigned subjects across multiple concurrent protocols without dropping the ball
• Communicate proactively with sponsors, CROs, and central labs
• Flag bottlenecks and propose fixes we move faster when you do

What You Bring

Required

• 2+ years as a CRC, research nurse, or clinical research assistant in industry-sponsored trials
• Working knowledge of GCP, ICH E6(R2/R3), and FDA 21 CFR Part 11
• Hands-on experience with at least one major EDC platform
• Comfort with phlebotomy, vitals, and ECG acquisition (or willingness to certify)
• Strong written documentation skills you write source notes a monitor will love

Preferred

• ACRP or SOCRA certification (CCRC, CCRP)
• IATA dangerous goods shipping certification
• Experience across multiple therapeutic areas, especially cardiology, endocrinology, or vascular
• Spanish proficiency
• Prior experience at a site network or multi-protocol site

Who Thrives Here

• Self-directed. You don't wait to be told what's next; you check the visit schedule and run.
• Detail-anchored. You catch the missed initial on a source doc before the monitor does.
• Calm under multiple deadlines. Three patients, two queries, and a sponsor call before lunch doesn't rattle you.
• Curious. You want to understand the science, not just check boxes.
• Direct communicator. You raise problems early, in plain language.

Compensation & Benefits

• Competitive base salary commensurate with experience
• Health, dental, vision
• PTO and paid holidays
• Paid certification renewals and continuing education
• Career growth into Lead CRC, Site Manager, or therapeutic specialist tracks

Emvera Health is an Equal Opportunity Employer.