Clinical Research Coordinator II

Care Access•Hoboken, NJ

7d•$60,000 - $90,000•Onsite

About The Position

The Clinical Research Coordinator II uses Good Clinical Practices to screen, enroll, and monitor clinical research study participants while ensuring protocol and regulatory compliance. The role involves coordinating participant care, conducting study visits and procedures, maintaining accurate study documentation, supporting recruitment, and collaborating with investigators, site personnel, sponsors, and CRO representatives. The coordinator handles moderate-complexity studies involving mixed visit types, investigational product, and adverse event workflows, and may operate as the sole CRC onsite. The role also includes mentoring CRC I peers and providing onboarding and day-to-day guidance.

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 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 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 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, and institutional SOPs.
Maintain effective relationships with study participants and Care Access Research personnel while balancing protocol requirements with participant experience and addressing concerns.
Monitor quality metrics, prevent protocol deviations, resolve queries promptly, and escalate complex issues as needed.
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 where appropriate.
Prescreen study candidates and obtain informed consent in accordance with Care Access Research SOPs.
Complete protocol-required visit procedures and 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.
Discuss study medication, required procedures, eligibility criteria, and effects on office flow with the Investigator and site staff.
Record study data legibly and enter it 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-provided timelines.
Assist regulatory personnel with completing and filing regulatory documents, and assist in creating and reviewing 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 call and recruit study participants.
Review protocols and amendments for clarity and logistical feasibility; ensure required training and study requirements are completed before trial conduct.
Communicate clearly in writing and verbally, anticipate needs, propose solutions, manage change, and facilitate stakeholder communications and meetings.
Ensure study supplies are available before protocol initiation, including lab kits, study medication, specialized equipment, and IVRS/EDC access and passwords.
Own studies and prioritize competing demands while operating independently for most study activities.
Travel regionally as required, up to 10%, based on study requirements, staff needs, and company initiatives.