Clinical Research Coordinator I

Care Access; Raleigh (NC); On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

PTO

Employer-paid health insurance

Health Savings Account (HSA)

Bi-weekly HSA employer contribution

Short-Term Disability

Long-Term Disability

401(k) with company match

Job summary

Care Access is seeking a Clinical Research Coordinator to screen, enroll, and monitor study subjects in compliance with GCP and protocol requirements. You will work onsite, handle informed consent, conduct basic procedures, and support regulatory documentation.

The role emphasizes adherence to FDA regulations, data integrity, and collaboration with investigators and sponsor/CRO staff. Onsite 5 days/week with up to 10% travel; competitive benefits offered.

Qualifications

• Bachelor’s Degree preferred, or equivalent combination of education, training, and experience.
• A minimum of 1-year prior Clinical Research Coordinator experience required.
• Recent phlebotomy experience required.
• Excellent working knowledge of medical and research terminology.
• Excellent working knowledge of federal regulations, good clinical practices (GCP).

Responsibilities

• Obtain informed consent per Care Access Research SOP.
• Demonstrates empathy; follows patient privacy and safety protocols.
• Complete visit procedures in accordance with protocol.
• Complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
• 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 notify PI and Sponsor.
• Record data accurately in source documents or electronic systems.
• Assist in planning and creation of recruitment materials and strategies.

Skills

GCP knowledge

FDA regulations

ICH guidelines

Clinical trials coordination

Regulatory documentation

Education

Bachelor's degree preferred

1 year CRC experience

Phlebotomy experience

Tools

Clinical trials database

IVR systems

Electronic data capture

MS Word

MS Excel

Job description

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 to 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.

With programs like Future Medicine, which makes advanced health screenings and research opportunities accessible to communities 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. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.

The Clinical Research Coordinator’s primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.

How You'll Make An Impact

• Obtain informed consent per Care Access Research SOP .
• Demonstrates empathy; follows patient privacy and safety protocols.
• Complete visit procedures in accordance with protocol.
• Complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
• Receives structured mentorship; participates in shadowing and skills validation.
• Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
• Low complexity; stable protocols with limited procedures and minimal IP handling.
• 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)
• 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.
• Assistwith planning and creation ofappropriate recruitmentmaterials.
• Assistindevelopmentof recruitment plan and obtainlistingof potential candidates to contact fromsubjectdatabase.
• Actively work with recruitment team in calling and recruiting participants
• Other Responsibilities
  • 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.
  • Adapts to new systems; seeks feedback; escalates issues.
  • Owns assigned tasks; meets deadlines with support.
  • 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.
• Excellent working knowledge of medical and research terminology
• Excellent working knowledge of federal regulations, good clinical practices (GCP)
• Executes tasks with supervision; requires frequent review and guidance for visits, consent support, and complex procedures.
• Ability to communicate and work effectively with a diverse team of professionals.
• Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
• Strong computer skills withdemonstratedabilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
• Critical thinker and problem solver
• Friendly, outgoing personality;maintaina positive attitude under pressure.
• High levelof self-motivation and energy
• Excellent professional writing and communication skills
• Communicates clearly with guidance; asks questions; respondstimely.
• Ability to work independently in a fast-paced environment with minimal supervision.

Certifications/Licenses, Education, and Experience:

• Bachelor’s Degree preferred, or equivalent combination of education, training, and experience.
• A minimum of 1-year prior Clinical Research Coordinator experience required
• Recent phlebotomy experience required

How We Work Together

• Location: Position requires onsite work 5 days per week
• Travel: This role requires up to 10% travel within 100 miles of site. Length of travel will depend upon study requirements, staff needs, and company initiatives.
• Physical demands associated with this position Include
  • Walking, Standing, Sitting, Lifting (Up to and Overhead 25 lbs), and Driving - 20% each

The expected pay range for this role is $55,000 - $85,000 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.

Diversity & Inclusion

We work with and serve people from diverse cultures and communities around the world. 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, and 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.

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For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Care Access’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

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