Clinical Research Coordinator II, RN

Care Access•Ogden, UT

10d•$75,000 - $110,000•Onsite

About The Position

The Clinical Research Coordinator II, RN conducts delegated clinical tasks and monitors research participants in accordance with Good Clinical Practices (GCP), protocol requirements, and regulatory standards. The role coordinates patient visits and study activities, performs RN-specific clinical procedures, manages investigational products and study documentation, and supports recruitment and trial operations. This is a moderately complex role involving mixed visit types and active investigational product and adverse event workflows. The coordinator may work as the sole CRC onsite, independently own studies, prioritize competing demands, and mentor CRC I peers through onboarding and day-to-day guidance. The position is onsite and requires up to 80% regional travel within 100 miles, depending on study requirements, staffing needs, and company initiatives. Physical activities include keyboard and computer use, walking, standing, sitting, lifting (including loads up to and over 25 pounds and overhead lifting), and driving; each activity is listed at 20%. The expected pay range is $75,000–$110,000 USD per year for full-time team members.

Requirements

At least 3 years of prior Clinical Research Coordinator experience.
At least 1 year of experience as an RN.
Recent phlebotomy experience.
RN license in good standing.
Phlebotomy and infusion experience.
Ability to understand and follow institutional SOPs.
Working knowledge of medical and research terminology, federal regulations, and Good Clinical Practices (GCP).
Excellent phlebotomy skills.
Ability to communicate and work effectively with a diverse team of professionals.
Ability to work collaboratively and support team members in achieving shared goals.
Ability to work independently in a fast-paced environment with minimal supervision.
Strong organizational skills, including the ability to prioritize, delegate, direct, support, assign, and evaluate work, and follow through on assignments.
Strong verbal and written communication skills.
Ability to balance tasks with competing priorities.
Strong computer skills.
Critical thinking and problem-solving ability.
Self-motivation, energy, curiosity, and willingness to learn and innovate.
Ability to maintain a positive attitude under pressure and a client-service mentality.
Willingness to travel up to 80% regionally, within 100 miles.
Ability to use keyboards and other computer equipment and to perform the listed physical activities, including walking, standing, sitting, lifting, and driving.

Nice To Haves

One year of experience as a Care Access Research Clinical Research Coordinator.

Responsibilities

Prescreen study candidates and obtain informed consent in accordance with Care Access Research SOPs.
Complete protocol-based study visits and basic clinical procedures, including blood draws, vital signs, and ECGs.
Review laboratory, ECG, MRI, and other test results for completeness and alert values, and ensure timely investigator review.
Coordinate with investigators and site staff regarding study medication, procedures, eligibility criteria, and office flow.
Prioritize study activities according to protocol timelines and maintain compliance with FDA regulations and ICH guidelines.
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Identify adverse events and serious adverse events and promptly notify the Principal Investigator and Sponsor when appropriate.
Balance protocol requirements with participant experience and address participant concerns proactively.
Mentor CRC I peers and provide onboarding and day-to-day guidance.
Prepare and administer investigational product, monitor participants for adverse reactions, perform phlebotomy, insert IV catheters, and conduct other delegated protocol procedures.
Maintain investigational product records, preserve blinding where required, and ensure appropriate medication and investigational product storage, security, and temperature.
Record study data legibly and in real time in paper or electronic source documents.
Accurately document study medication inventory, dispensing, and participant compliance.
Resolve data management queries and correct source data within sponsor timelines.
Assist regulatory personnel with regulatory documents and assist in creating and reviewing source documents.
Assist with recruitment materials and recruitment plans, obtain potential candidate listings from subject databases, and work with the recruitment team to contact and recruit participants.
Review protocols and amendments for clarity and logistical feasibility.
Ensure required training and study requirements are completed before trial conduct.
Communicate clearly verbally and in writing, and attend Investigator meetings as required.
Ensure necessary supplies and access are available for protocol initiation, including lab kits, study medication, specialized equipment, and IVRS/EDC access and passwords.
Maintain positive, professional relationships with participants, sponsor representatives, investigators, Care Access Research personnel, and management.
Operate independently for most study activities, manage stakeholder communications, facilitate visits and meetings, and escalate complex issues as needed.
Own studies and prioritize competing demands.