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Clinical Research Coordinator II

Job Overview

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Employment Type

Full-time
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Compensation

Salary
Range $60,000.00 - $90,000.00
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Work Schedule

Standard Hours
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Benefits

Paid Time Off
Paid holidays
Medical insurance
Dental Insurance
Vision Insurance
Health savings account
Flexible spending account
short-term disability
long-term disability
401(k) retirement plan
company match
Relocation support

Job Description

Care Access is a global clinical research company dedicated to transforming the future of health care by making advanced medical research and health services accessible to diverse communities worldwide. With a network of hundreds of research locations, mobile clinics, and clinicians, Care Access bridges the gap between patients and medical advancements, especially in areas where barriers to care are prevalent. The company is committed to ensuring that every individual has the opportunity not only to understand their health but also to participate in cutting-edge medical breakthroughs that improve lives across the globe. Through innovative programs such as Future of Medicine and Difference Makers, Care Access empowers communities by offering advanced health screenings, research participation opportunities, and supporting local leaders in their efforts to enhance community health and well-being. The company’s approach combines strong partnerships, technology, and persistent dedication to reimagine the delivery of clinical research and health services, creating a future where health care is more inclusive and accessible for all.

The Clinical Research Coordinator (CRC) role at Care Access is a pivotal position responsible for coordinating and managing clinical research studies with a strict adherence to Good Clinical Practices (GCP). This role entails screening, enrolling, and closely monitoring study subjects while maintaining compliance with regulatory protocols and ethical standards. The CRC plays a critical role in patient coordination by prioritizing protocol timelines, ensuring FDA and ICH guideline compliance, and balancing patient care needs with research requirements. They maintain effective relationships with study participants, clinical staff, sponsors, and investigators, fostering a positive and professional environment.

Key responsibilities include conducting basic clinical procedures such as blood draws, vital signs assessments, and ECGs, obtaining informed consent, and ensuring accurate documentation and data entry for clinical trials. The CRC also helps with patient recruitment by assisting in planning and executing recruitment strategies and working closely with the recruitment team to enroll appropriate candidates. This role requires moderate complexity handling with mixed visit types and active management of investigational products and adverse event workflows. The CRC operates independently for most study activities, providing mentorship to junior staff and ensuring all study requirements and supplies are managed effectively.

Candidates must have a minimum of three years’ experience as a Clinical Research Coordinator, with a preference for prior experience at Care Access. Phlebotomy skills and familiarity with clinical trial databases, electronic data capture systems, and regulatory documentation are essential. The role demands excellent organizational, communication, and problem-solving skills, alongside the ability to work effectively in a fast-paced, collaborative environment. The position is full-time, on-site, and requires up to 10% regional travel, with physical demands including walking, standing, sitting, lifting, and driving.

Care Access offers competitive compensation with a salary range of $60,000 to $90,000 USD annually for full-time team members. The benefits package is comprehensive, including paid time off, employer-paid medical, dental, and vision insurance, health savings accounts, short and long-term disability coverage, a 401(k) retirement plan with company match, and relocation support. The company is committed to diversity and inclusion, creating a workplace where all individuals feel valued and respected. Care Access is an equal opportunity employer and maintains compliance with relevant employment laws and accommodations for applicants.

Job Requirements

  • Bachelor's degree preferred or equivalent combination of education training and experience
  • Minimum three years’ clinical research coordinator experience required
  • Recent phlebotomy experience required
  • Ability to work on-site with regional commute requirements
  • Availability for up to 10 percent regional travel
  • Ability to perform physical tasks including walking standing sitting lifting up to 25lbs and driving
  • Ability to adhere to FDA regulations and institutional SOPs
  • Strong attention to detail and organizational skills
  • Effective verbal and written communication skills

Job Qualifications

  • Bachelor's degree preferred or equivalent combination of education training and experience
  • Minimum three years’ experience as a clinical research coordinator
  • One year experience as a Care Access research clinical research coordinator preferred
  • Recent phlebotomy experience required
  • Excellent working knowledge of medical and research terminology
  • Strong computer skills including clinical trial databases electronic data capture IVR systems MS Word and Excel
  • Ability to understand and follow institutional SOPs
  • Excellent professional writing and communication skills
  • Strong organizational prioritization and leadership skills
  • Critical thinking and problem-solving abilities
  • Ability to communicate and work effectively with diverse teams
  • Ability to work independently in a fast-paced environment with minimal supervision

Job Duties

  • Utilize good clinical practices in screening enrolling and monitoring study subjects
  • Maintain adherence to FDA regulations and ICH guidelines
  • Maintain effective relationships with study participants and research personnel
  • Coordinate and attend study visits including pre-study site visits and monitor visits
  • Obtain informed consent and complete clinical procedures such as blood draws and ECGs
  • Record and enter data accurately on paper or electronic sources
  • Assist in patient recruitment and development of recruitment materials
  • Review and assess study protocols for clarity and feasibility
  • Resolve data management queries and assist with regulatory document filing
  • Mentor junior clinical research coordinators and provide day-to-day guidance
  • Identify and report adverse events and serious adverse events promptly
  • Communicate clearly with investigators site staff and sponsors
  • Ensure adequate study supplies on site and manage inventory
  • Operate independently in managing study activities and addressing protocol deviations

Job Criteria

Experience

Mid Level (3-7 years)


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