Clinical Research Coordinator II

Care Access•Saint Louis, MO

1d•Onsite

About The Position

The Clinical Research Coordinator II uses Good Clinical Practices (GCP) to screen, enroll, and closely monitor clinical research study participants while ensuring protocol and regulatory compliance. The role handles moderately complex studies with mixed visit types and active investigational product and adverse-event workflows, and may work as the sole CRC onsite. The coordinator operates independently for most study activities, escalating complex issues as needed, and mentors CRC I colleagues through onboarding and day-to-day guidance. This is an onsite position with regional commute requirements and up to 10% regional travel, generally within 100 miles. Travel duration depends on study requirements, staffing needs, and company initiatives. The expected annual pay range for full-time team members is $60,000–$90,000 USD.

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 close 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.
Bachelor’s degree preferred, or an equivalent combination of education, training, and experience.

Nice To Haves

One year of experience as a Care Access Research Clinical Research Coordinator.

Responsibilities

Prioritize activities according to protocol timelines and maintain adherence to FDA regulations, ICH guidelines, institutional SOPs, and study protocols.
Build and maintain effective relationships with study participants, investigators, site staff, and Care Access Research personnel; balance protocol needs with the patient experience and address concerns proactively.
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 (AEs) and serious adverse events (SAEs), and promptly notify the Principal Investigator and Sponsor where appropriate.
Prescreen study candidates and complete 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, and other test results, such as MRIs, 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.
Legibly record study data and enter it in real time in paper or electronic source documents.
Accurately record study medication inventory and dispensation, and document 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, developing recruitment plans, and obtaining candidate lists from subject databases.
Work with the recruitment team to contact and recruit study participants.
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.
Attend Investigator meetings as required and manage studies while prioritizing competing demands.
Ensure supplies and access needed for protocol initiation are available onsite, including lab kits, study medication, specialized equipment, and IVRS/EDC access and passwords.
Facilitate stakeholder communications, visits, and meetings.
Use keyboards and other computer equipment; perform the listed activities of walking, standing, sitting, lifting, and driving, each stated at 20%.