Clinical Research Coordinator II

Care Access•Arlington, VA

6d•Onsite

About The Position

Care Access is hiring a Clinical Research Coordinator II to conduct clinical research studies using Good Clinical Practices while screening, enrolling, and monitoring participants and maintaining protocol and regulatory compliance. The coordinator manages studies of moderate complexity, including mixed visit types and active investigational product and adverse-event workflows, and may operate as the sole coordinator onsite. The role also mentors Clinical Research Coordinator I peers and provides onboarding and day-to-day guidance. This is an onsite position with regional commute requirements and up to 10% regional travel, within 100 miles. Travel duration depends on study requirements, staffing needs, and company initiatives. The expected pay range for full-time team members is $60,000–$90,000 per year. Care Access is unable to sponsor work visas at this time.

Requirements

At least 3 years of prior Clinical Research Coordinator experience.
Recent phlebotomy experience.
Ability to understand and follow institutional SOPs.
Excellent working knowledge of medical and research terminology, federal regulations, and Good Clinical Practices.
Ability to operate independently for most study activities and escalate complex issues as needed.
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization, and leadership skills, with close attention to detail.
Strong computer skills, including experience with clinical trials databases, IVR systems, electronic data capture, Microsoft Word, and Microsoft Excel.
Critical-thinking and problem-solving ability.
Friendly, outgoing manner and ability to maintain a positive attitude under pressure.
High self-motivation and energy.
Excellent professional writing and communication skills.
Ability to work independently in a fast-paced environment with minimal supervision.

Nice To Haves

Bachelor’s degree preferred, or an equivalent combination of education, training, and experience.
One year of experience as a Care Access Research Clinical Research Coordinator preferred.

Responsibilities

Prioritize activities according to protocol timelines and maintain compliance with FDA regulations, ICH guidelines, institutional SOPs, and study protocols.
Build effective relationships with study participants, investigators, Care Access Research personnel, and management; address participant concerns and balance protocol needs with the patient experience.
Monitor quality metrics, prevent protocol deviations, resolve queries promptly, and escalate complex issues when needed.
Coordinate and attend pre-study site visits, site initiation visits, monitor visits, and required investigator meetings with clinical staff and Sponsor/CRO representatives.
Mentor CRC I peers and provide onboarding and day-to-day guidance.
Prescreen study candidates and actively support participant recruitment, including planning recruitment materials, developing recruitment plans, contacting potential candidates, and working with the recruitment team.
Obtain informed consent according to Care Access Research SOPs and complete protocol-required visits and procedures.
Perform basic clinical procedures, including blood draws, vital signs, and ECGs.
Review laboratory, ECG, MRI, and other test results for completeness and alert values, and ensure timely investigator review.
Identify adverse events and serious adverse events and promptly notify the Principal Investigator and Sponsor where appropriate.
Discuss study medication, procedures, eligibility criteria, and effects on office flow with the Investigator and site staff.
Record study data legibly and in real time on paper or electronic source documents.
Accurately track study medication inventory, dispensation, and participant compliance.
Resolve data management queries and correct source data within sponsor timelines.
Assist regulatory personnel with completing and filing regulatory documents, and help create and review source documents.
Review protocols and amendments for clarity and logistical feasibility; ensure training and study requirements are met before trial conduct.
Communicate clearly in writing and verbally, anticipate needs, propose solutions, and manage change effectively.
Ensure supplies and access needed for protocol initiation are available, including lab kits, study medication, specialized equipment, and IVRS/EDC access and passwords.
Own studies, prioritize competing demands, and manage stakeholder communications and visits or meetings.