Clinical Research Coordinator II

Care Access•Hoboken, NJ

9d•Onsite

About The Position

Care Access is hiring a Clinical Research Coordinator II to conduct clinical research studies using Good Clinical Practices (GCP) while screening, enrolling, and monitoring study participants and maintaining protocol and regulatory compliance. The coordinator works independently on most study activities, may operate as the sole CRC onsite, and handles studies of moderate complexity, including mixed visit types and active investigational product and adverse-event workflows. The role also mentors CRC I peers and provides onboarding and day-to-day guidance. The coordinator supports participant care and study conduct from prescreening and informed consent through study visits, safety monitoring, documentation, and recruitment. The position requires coordination with investigators, site staff, participants, regulatory personnel, recruitment teams, sponsors, and CRO representatives. It is an onsite role with regional commute requirements and up to 10% regional travel, within 100 miles, depending on study requirements, staffing needs, and company initiatives.

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 when needed.
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization, and leadership skills, with attention to detail.
Strong computer skills, including experience 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 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 role's physical demands, including walking, standing, sitting, lifting, and driving.

Nice To Haves

Bachelor’s degree preferred, or 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 adherence to FDA regulations, ICH guidelines, institutional SOPs, and study protocols.
Build effective relationships with participants and Care Access Research personnel; balance protocol needs with participant experience and proactively address concerns.
Monitor quality metrics, prevent protocol deviations, resolve queries promptly, and communicate professionally with patients, representatives, investigators, colleagues, and management.
Coordinate and attend pre-study site visits, site initiation visits, monitor visits, and investigator meetings as required.
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 when appropriate.
Prescreen study candidates, obtain informed consent according to Care Access Research SOPs, and complete protocol-required visit procedures.
Perform 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, procedures, eligibility criteria, and effects on office flow with the investigator and site staff.
Record study data legibly and in real time in paper or electronic source documents.
Accurately document study medication inventory, dispensation, and participant compliance.
Resolve data-management queries and correct source data within sponsor timelines.
Assist regulatory personnel with completion and filing of regulatory documents and help create and review source documents.
Assist with planning and creating recruitment materials and developing recruitment plans; obtain potential-candidate listings from subject databases.
Work with the recruitment team to contact and recruit study subjects.
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 required supplies and access are available for protocol initiation, including lab kits, study medication, specialized equipment, and IVRS/EDC access and passwords.
Manage competing demands and study ownership, facilitate stakeholder communications and visits, and work independently with minimal supervision.