Clinical Research Coordinator II

Care Access•Arlington, VA

1d•$60,000 - $90,000•Onsite

About The Position

The Clinical Research Coordinator uses Good Clinical Practices (GCP) to screen, enroll, and monitor clinical research participants while ensuring protocol and regulatory compliance. This is a moderate-complexity role involving mixed visit types and active investigational product and adverse-event workflows. The coordinator can operate independently onsite, owns studies, prioritizes competing demands, and mentors CRC I colleagues. The role includes coordinating participant visits and clinical procedures, maintaining accurate study documentation and medication records, addressing data queries, supporting recruitment and regulatory activities, and coordinating with investigators, site staff, sponsors, CRO representatives, and participants. The position is onsite and includes regional commute requirements, with up to 10% regional travel within 100 miles. The expected pay range for full-time team members is $60,000–$90,000 USD per year.

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 (GCP).
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 strong attention to detail.
Strong computer skills, including demonstrated ability with clinical trials databases, IVR systems, electronic data capture, Microsoft Word, and Excel.
Critical-thinking and problem-solving skills.
Friendly, outgoing manner and ability to maintain a positive attitude under pressure.
High level of self-motivation and energy.
Excellent professional writing and communication skills.
Ability to work independently in a fast-paced environment with minimal supervision.
Ability to use keyboards and other computer equipment.
Ability to meet the physical demands of walking, standing, sitting, lifting up to 25 pounds, lifting over 25 pounds overhead, and driving; each activity is listed at 20%.

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 study activities with regard to protocol timelines and balance protocol needs with participant experience.
Maintain adherence to FDA regulations, ICH guidelines, institutional SOPs, and study protocols.
Maintain effective relationships with study participants and Care Access Research personnel, and communicate professionally with patients, representatives, investigators, staff, and management.
Monitor quality metrics, prevent protocol deviations, and resolve queries promptly.
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Mentor CRC I peers and provide onboarding and day-to-day guidance.
Identify adverse events and serious adverse events and promptly notify the Principal Investigator and Sponsor where appropriate.
Prescreen study candidates and obtain informed consent in accordance with Care Access Research SOPs.
Complete visit procedures and basic clinical procedures, including blood draws, vital signs, and ECGs.
Review laboratory, ECG, and other test results for completeness and alert values, and ensure timely investigator review.
Discuss study medication, required procedures, eligibility criteria, and effects on office flow with the Investigator and site staff.
Record data legibly and in real time on paper or e-source documents.
Accurately record study medication inventory, dispensing, and participant compliance.
Resolve data-management queries and correct source data within sponsor-provided timelines.
Assist regulatory personnel with completing and filing regulatory documents, and assist with creating and reviewing source documents.
Assist in planning and creating recruitment materials and developing recruitment plans.
Obtain lists of potential candidates from subject databases and work with the recruitment team to contact and recruit participants.
Review protocols, including amendments, for clarity and logistical feasibility.
Ensure training and study requirements are met before trial conduct.
Anticipate needs, propose solutions, and manage change effectively.
Attend Investigator meetings as required.
Ensure adequate supplies are onsite for protocol initiation, including lab kits, study medication, specialized equipment, and IVRS/EDC access and passwords.
Manage stakeholder communications and facilitate visits and meetings.