
Job Overview
Compensation
Salary
Range $60,000.00 - $90,000.00
Benefits
Paid Time Off
Company paid holidays
Medical insurance
Dental Insurance
Vision Insurance
Health savings account
flexible spending accounts
short-term disability
long-term disability
401(k) retirement plan
company match
Relocation support
Job Description
Care Access is a global healthcare research organization dedicated to advancing the future of health for all individuals. Operating through hundreds of research locations, mobile clinics, and a network of clinicians worldwide, Care Access bridges the gap between cutting-edge medical research and communities that often encounter barriers to accessing quality healthcare. Their mission is to ensure that every person has the opportunity to understand their health status, receive necessary medical care, and actively participate in the medical breakthroughs that will shape tomorrow's healthcare landscape. With innovative programs like Future of Medicine, which provides advanced health screenings and research opportunities globally, and Difference Makers, which supports local leaders in enhancing community health and wellbeing, Care Access places people at the very core of medical progress. Utilizing strategic partnerships, forward-thinking technology, and a commitment to inclusivity, Care Access is revolutionizing how clinical research and health services are delivered, aiming to create a more accessible and equitable future of healthcare.
This role is for a Clinical Research Coordinator at Care Access, a pivotal position responsible for overseeing the coordination and management of clinical research studies in compliance with Good Clinical Practices (GCP). The coordinator will engage in various duties such as screening, enrolling, and closely monitoring research subjects while maintaining strict adherence to protocols and regulatory standards. This full-time, on-site role requires a regional commute and involves up to 10% regional travel within 100 miles. The Clinical Research Coordinator ensures protocol timelines are met, FDA regulations and ICH guidelines are followed, and that patient experience remains a priority. The position includes interaction with study participants, care access personnel, sponsors, and investigators, requiring excellent communication and organizational abilities. Key responsibilities encompass patient coordination, documentation accuracy, patient recruitment, and study oversight with moderate complexity, including adverse event identification and reporting. The coordinator will also mentor junior staff and actively contribute to study initiation and monitoring visits.
Candidates should possess a bachelor's degree or an equivalent combination of education, training, and experience, with at least three years of clinical research coordination experience. Experience within Care Access Research and recent phlebotomy skills are preferred. Strong knowledge of medical and research terminology, federal regulations, and clinical trial systems such as electronic data capture and IVR systems is essential. The role demands high levels of self-motivation, leadership, problem-solving skills, attention to detail, and the ability to work independently in a fast-paced environment. The Clinical Research Coordinator plays an integral role in facilitating research that leads to impactful healthcare advancements, supported by a comprehensive benefits package including medical, dental, and vision insurance, PTO, disability coverage, retirement plans with company match, and relocation support. Care Access strongly supports diversity and inclusion, fostering a workplace environment where individuals from diverse backgrounds feel valued and respected, and is committed to providing equal opportunity employment.
This role is for a Clinical Research Coordinator at Care Access, a pivotal position responsible for overseeing the coordination and management of clinical research studies in compliance with Good Clinical Practices (GCP). The coordinator will engage in various duties such as screening, enrolling, and closely monitoring research subjects while maintaining strict adherence to protocols and regulatory standards. This full-time, on-site role requires a regional commute and involves up to 10% regional travel within 100 miles. The Clinical Research Coordinator ensures protocol timelines are met, FDA regulations and ICH guidelines are followed, and that patient experience remains a priority. The position includes interaction with study participants, care access personnel, sponsors, and investigators, requiring excellent communication and organizational abilities. Key responsibilities encompass patient coordination, documentation accuracy, patient recruitment, and study oversight with moderate complexity, including adverse event identification and reporting. The coordinator will also mentor junior staff and actively contribute to study initiation and monitoring visits.
Candidates should possess a bachelor's degree or an equivalent combination of education, training, and experience, with at least three years of clinical research coordination experience. Experience within Care Access Research and recent phlebotomy skills are preferred. Strong knowledge of medical and research terminology, federal regulations, and clinical trial systems such as electronic data capture and IVR systems is essential. The role demands high levels of self-motivation, leadership, problem-solving skills, attention to detail, and the ability to work independently in a fast-paced environment. The Clinical Research Coordinator plays an integral role in facilitating research that leads to impactful healthcare advancements, supported by a comprehensive benefits package including medical, dental, and vision insurance, PTO, disability coverage, retirement plans with company match, and relocation support. Care Access strongly supports diversity and inclusion, fostering a workplace environment where individuals from diverse backgrounds feel valued and respected, and is committed to providing equal opportunity employment.
Job Requirements
- Bachelor's degree or equivalent combination of education, training, and experience
- minimum of three years clinical research coordinator experience
- recent phlebotomy experience
- ability to understand and follow institutional SOPs
- excellent working knowledge of medical and research terminology
- working knowledge of federal regulations and Good Clinical Practices (GCP)
- ability to operate independently with escalation of complex issues
- strong organizational and leadership skills
- strong computer skills with clinical trials database, IVR systems, and electronic data capture experience
- excellent communication skills
- ability to work independently in a fast-paced environment
- friendly and positive demeanor even under pressure
- willingness to travel regionally up to 10%
- ability to perform basic clinical procedures including blood draws, vital signs, and ECGs
- ability to lift up to 25 pounds and perform other physical demands including walking, standing, and sitting
Job Qualifications
- Bachelor's degree preferred or equivalent combination of education, training, and experience
- minimum three years prior clinical research coordinator experience
- preferred one year experience as Care Access Research Clinical Research Coordinator
- recent phlebotomy experience required
- excellent working knowledge of medical and research terminology
- excellent working knowledge of federal regulations and Good Clinical Practices (GCP)
- strong organizational and prioritization skills with attention to detail
- strong computer skills including clinical trials databases, IVR systems, electronic data capture, MS Word, and Excel
- excellent professional writing and communication skills
- ability to understand and follow institutional SOPs
- ability to work effectively with diverse teams
- critical thinker and problem solver
- ability to work independently in a fast-paced environment with minimal supervision
- excellent interpersonal skills with a friendly and outgoing personality
- high level of self-motivation and energy
Job Duties
- Prioritize activities with specific regard to protocol timelines
- maintain adherence to FDA regulations and ICH guidelines in conducting clinical trials
- maintain effective relationships with study participants and Care Access personnel
- balance protocol needs with patient experience and proactively address concerns
- monitor quality metrics, prevent deviations, and resolve queries quickly
- interact professionally with patients, representatives, investigators, and management
- coordinate and attend pre-study site visits, site initiation visits, and monitor visits
- mentor CRC I peers and provide onboarding and day-to-day guidance
- identify adverse events and promptly notify Principal Investigator and Sponsor
- operate independently as solo CRC onsite
- prescreen study candidates
- obtain informed consent per SOP
- complete visit procedures according to protocol
- perform basic clinical procedures such as blood draws, vital signs, and ECGs
- review laboratory and test results for completeness and alert values
- discuss study medication, procedures, eligibility criteria with investigator and staff
- record data legibly and enter in real time
- accurately record study medication inventory and patient compliance
- resolve data management queries within sponsor timelines
- assist regulatory personnel with regulatory documents
- assist in creating and reviewing source documents
- assist with planning and creation of recruitment materials
- develop recruitment plans and obtain listings of potential candidates
- actively work with recruitment teams
- review and assess protocols for clarity and feasibility
- ensure all training and study requirements are met prior to trial conduct
- communicate clearly verbally and in writing
- anticipate needs, propose solutions, and manage change efficiently
- attend investigator meetings as required
- manage competing demands and priorities
- ensure adequate supplies for protocol initiation are received onsite
Job Criteria
Experience
Mid Level (3-7 years)
Job Location
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