How This Role Makes a DifferenceThe
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
