Clinical Research Coordinator II

Care Access•St. Louis, MO

12d•$60,000 - $90,000•Onsite

About The Position

The Clinical Research Coordinator II uses Good Clinical Practices (GCP) to screen, enroll, and closely monitor clinical research study subjects while ensuring protocol and regulatory compliance. The role independently manages most study activities, including moderate-complexity studies with mixed visit types and active investigational product and adverse event workflows, and may operate as the sole onsite CRC. The coordinator balances protocol requirements with patient experience, monitors quality metrics, prevents deviations, resolves queries, and escalates complex issues as needed. The position coordinates with study participants, investigators, Care Access Research personnel, and Sponsor/CRO representatives. It includes conducting and documenting study visits and clinical procedures, supporting recruitment and regulatory documentation, monitoring study medication and supplies, and mentoring CRC I peers. This is an onsite role with regional commute requirements and up to 10% regional travel (within 100 miles).

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 experience with clinical trials databases, IVR systems, electronic data capture, Microsoft Word, and Excel.
Critical-thinking and problem-solving skills.
Friendly, outgoing demeanor 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.
Bachelor’s degree or an equivalent combination of education, training, and experience.

Nice To Haves

Bachelor’s degree preferred.
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, and institutional SOPs.
Maintain effective relationships with study participants and Care Access Research personnel; balance protocol needs with patient experience and proactively address concerns.
Monitor quality metrics, prevent deviations, and resolve queries promptly.
Interact professionally with patients, representatives, investigators, Care Access Research personnel, and management.
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 (AEs) and serious adverse events (SAEs), and promptly notify the Principal Investigator and Sponsor where appropriate.
Prescreen study candidates and obtain informed consent according to Care Access Research SOPs.
Complete protocol-required 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 study data legibly and in real time in paper or e-source documents.
Accurately record study medication inventory, dispensing, and patient 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 with planning and creating recruitment materials and developing recruitment plans; obtain lists of potential candidates from subject databases.
Work with the recruitment team to contact and recruit subjects.
Review protocols and amendments for clarity and logistical feasibility.
Ensure training and study requirements are met before trial conduct.
Communicate clearly verbally and in writing; anticipate needs, propose solutions, and manage change effectively.
Attend Investigator meetings as required.
Own assigned studies, prioritize competing demands, and mentor CRC I staff.
Ensure required supplies and access are available for protocol initiation, including lab kits, study medication, specialized equipment, and IVRS/EDC access and passwords.
Facilitate stakeholder communications, visits, and meetings.