Clinical Research Coordinator II, RN

Care Access•Ogden, UT

10d•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 applicable regulations. This is a moderate-complexity role involving mixed visit types and active investigational product and adverse event workflows. The coordinator may operate as the sole CRC onsite, owns studies, prioritizes competing demands, and mentors CRC I peers by providing onboarding and day-to-day guidance. The role coordinates participant screening, informed consent, study visits, clinical procedures, test-result review, investigational product handling, study documentation, and recruitment. It also supports site visits and meetings, ensures study readiness and adequate supplies, and maintains effective communication with participants, investigators, sponsor/CRO representatives, and Care Access Research staff. The position is onsite and requires up to 80% regional travel within 100 miles. Physical activities include keyboard and computer use, walking, standing, sitting, lifting, and driving; lifting includes items up to 25 pounds and over 25 pounds, as well as overhead lifting.

Requirements

At least 3 years of prior Clinical Research Coordinator experience.
At least 1 year of experience as an RN.
RN license in good standing.
Recent phlebotomy experience.
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 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 others' work and follow through on assignments.
Strong verbal and written communication skills.
Strong computer skills.
Ability to balance tasks and competing priorities.
Critical-thinking and problem-solving skills.
Self-motivation, energy, curiosity, passion for learning and innovation, and willingness to take thoughtful risks and get things done.
Friendly, outgoing manner and ability to maintain a positive attitude under pressure.
Client service mentality.
Ability to use keyboards and other computer equipment.
Ability to travel regionally up to 80% within 100 miles.

Nice To Haves

At least 1 year of experience as a Care Access Research Clinical Research Coordinator.

Responsibilities

Prescreen study candidates and obtain informed consent according to Care Access Research SOPs.
Complete study visit procedures and basic clinical procedures, including blood draws, vital signs, and ECGs, in accordance with the protocol.
Review laboratory results, ECGs, and other test results for completeness and alert values, and ensure timely investigator review.
Discuss study medication, required procedures, eligibility criteria, and effects on office flow with the investigator and site staff.
Prioritize activities according to protocol timelines and maintain adherence to 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 needs with participant experience and proactively address participant concerns.
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-required clinical procedures.
Maintain investigational product records, required blinding, and proper medication and investigational product storage, security, and temperature.
Record study data legibly and in real time in paper or e-source documents.
Accurately record study medication inventory, dispensation, and participant compliance.
Resolve data management queries and correct source data within sponsor timelines.
Assist regulatory personnel with completing and filing regulatory documents and assist with creating and reviewing source documents.
Assist with planning and creating recruitment materials and developing recruitment plans; obtain potential-candidate listings from the subject database.
Work with the recruitment team to contact and recruit participants.
Review protocols and amendments for clarity and logistical feasibility, and ensure training and study requirements are met before trial conduct.
Communicate clearly verbally and in writing, attend Investigator meetings as required, and facilitate stakeholder communications and visits.
Ensure adequate 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 patients, sponsor representatives, investigators, and Care Access Research personnel and management.
Operate independently for most study activities, escalate complex issues as needed, and manage competing priorities.