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Care Access

Clinical Research Coordinator II

Care Access, Lima, Ohio, United States, 45807

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About Care Access

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world‑class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. Through programs such as Future of Medicine, which makes advanced health screenings and research opportunities accessible worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Together, we are building a future of health that is better and more accessible for all. Visit www.CareAccess.com for more information.

How This Role Makes a Difference The CRC I, RN conducts delegated clinical tasks and monitors 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

Train others and complete basic clinical procedures such as blood draws, vital signs, ECGs, etc.

Review laboratory results, ECGs, and other test results 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)

Conduct delegated clinical tasks (RN specific) and monitor participants in accordance with GCP. Clinical Tasks Include:

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 and 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

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 a 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

Strong computer skills

Ability to balance tasks with competing priorities

Critical thinker and problem solver

Curiosity and passion to learn, innovate, take thoughtful risks and get things done

Friendly, outgoing personality; maintain a positive attitude under pressure

High level of self‑motivation and energy

Must have a client service mentality

Certifications / Licenses, Education, and Experience

A minimum of 1 year of relevant work experience required

Clinical Research Experience preferred

Recent phlebotomy experience required

Licenses:

RN license in good standing required

Phlebotomy and infusion experience required

California based roles: National phlebotomy certification approved by the California Department of Public Health

Louisiana based roles: National phlebotomy certification approved by the Louisiana State Board of Medical Examiners

Washington based roles: National phlebotomy certification approved by the Washington State Department of Health

Nevada based roles: Laboratory Assistant certification by the Division of Public and Behavioral Health

How We Work Together

Location: Lima, OH

Travel: This role requires up to 80% travel. Travel will depend on study requirements, staff needs, and company initiatives.

Type of travel required: Regional (within 100 miles)

Physical demands:

Walking – 20%

Standing – 20%

Sitting – 20%

Lifting – 20% (up to 25 lbs, over 25 lbs, overhead)

Driving – 20%

Expected salary range: $70,000 – $100,000 USD per year for full‑time team members.

Benefits & Perks

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

Diversity & Inclusion We work with and serve people from diverse cultures and communities worldwide. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.

We are an equal‑opportunity employer, and all qualified applicants will receive consideration for employment without regard to or will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time.

If you need an accommodation to apply for this role, please reach out to: TalentAcquisition@careaccess.com

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