Clinical Research Coordinator II, RN
How This Role Makes a Difference
The CRC II, RN conducts delegated clinical tasks and monitoring of research participants in accordance with Good Clinical Practices (GCP), ensuring protocol and regulatory compliance.
How You'll Make An Impact
Patient Coordination
Prescreen study candidates
Obtain informed consent per Care Access Research SOP .
Complete visit procedures in accordance with protocol.
Complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
Prioritize activities with specific regard to protocol timelines
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
Balances protocol needs with patient experience; proactively addresses concerns.
Mentors CRC I peers; provides onboarding and day‑to‑day guidance.
Moderate complexity; mixed visit types, active IP and AE/SAE workflows.
Can operate as solo CRC onsite.
Conducts delegated clinical tasks (RN specific) and monitoring of research participants in accordance with Good Clinical Practices (GCP), ensuring protocol and regulatory compliance.
Clinical Tasks
Preparation and administration of Investigational Product (IP; study drug)
Monitor participant for adverse reactions
Perform phlebotomy and insert IV catheters
Conduct delegated clinical procedures as required per protocol
Maintain Investigational Product records in accordance with regulations and sponsor requirements.
Maintain the blinding of all study products where required.
Maintain proper storage, security and temperature for all medications and investigational products.
Documentation
Record data legibly and enter in real time on paper or e-source documents
Accurately record study medication inventory, medication dispensation, and patient compliance.
Resolve data management queries and correct source data within sponsor provided timelines
Assist regulatory personnel with completion and filing of regulatory documents.
Assist in the creation and review of source documents.
Patient Recruitment
Assist with planning and creation of appropriate recruitment materials.
Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
Actively work with recruitment team in calling and recruiting subjects
Review and assess protocol (including amendments) for clarity, logistical feasibility
Ensure that all training and study requirements are met prior to trial conduct.
Communicate clearly verbally and in writing.
Attend Investigator meetings as required.
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
Maintain effective relationships with study participants and other care Access Research personnel.
Owns studies; prioritizes competing demands; mentors CRC I.
The Expertise Required
Ability to understand and follow institutional SOPs.
Working knowledge of medical and research terminology
Working knowledge of federal regulations, good clinical practices (GCP)
Excellent phlebotomy skills
Ability to communicate and work effectively with a diverse team of professionals.
Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals.
Ability to work independently in a fast-paced environment with minimal supervision.
Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments.
Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors.
Operates independently for most study activities; escalates complex issues as needed.
Manages stakeholder communications; facilitates visits and meetings.
Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals.
Strong computer skills
Ability to balance tasks with competing priorities.
Critical thinker and problem solver.
Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done.
Friendly, outgoing personality; maintain a positive attitude under pressure.
High level of self-motivation and energy.
Ability to work independently in a fast-paced environment with minimal supervision.
Must have a client service mentality.
Certifications/Licenses, Education, and Experience
Minimum Education:
A minimum of 3 years prior Clinical Research Coordinator experience required
Minimum Experience:
Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator
Recent phlebotomy experience required
Minimum 1 year of experience as a RN required
Licenses:
RN license in good standing required.
Phlebotomy and infusion experience required.
How We Work Together
Location: This role is onsite.
Travel: This role requires up to 80% regional (within 100 miles) travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives.
Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
Walking - 20%
Standing - 20%
Sitting - 20%
Lifting - 20%
Up to 25lbs
Over 25lbs
Overhead
Driving - 20%
The expected pay range for this role is $75,000 - $110,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match
Mandatory Employer Disclosures
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.