Clinical Research Coordinator IIIGeneral Summary of Position: Under the guidance of the Clinical Trial Manager the Clinical Research Coordinator (CRC) III functions independently and proficiently with minimal oversight and is responsible for the complete coordination of assigned clinical research activities of all phases and all levels of complexity including investigator-initiated or other high profile research. Demonstrates competence in clinical research skills problem solving priority setting and supports less experienced staff. Required to enter study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable.
Primary Duties and Responsibilities:
Oversee clinical research studies to ensure compliance with regulatory requirements, Good Clinical Practice (GCP), institutional policies, and sponsor protocols.
Prepare, submit, and maintain regulatory documents, study records, delegation logs, and audit-ready documentation.
Coordinate informed consent, participant education, recruitment, retention, and study visits while prioritizing participant safety and rights.
Monitor and report adverse events, protocol deviations, and safety concerns; escalate issues to investigators as appropriate.
Ensure accurate and timely clinical data entry, validation, query resolution, and maintenance of electronic research databases.
Coordinate biospecimen collection, processing, storage, and transport in accordance with study protocols and safety requirements.
Manage investigational product accountability, participant randomization, and study supplies in accordance with sponsor and regulatory requirements.
Support study budgets, contracts, billing compliance, and appropriate allocation of research-related costs.
Coordinate study team training, sponsor communications, investigator meetings, site monitoring visits, and multisite research activities.
Prepare for and support internal and external audits, FDA inspections, and study initiation, monitoring, and closeout activities.
Collaborate with investigators, sponsors, and multidisciplinary teams to resolve study issues, improve research quality, and support departmental goals.
Maintain required research training and current knowledge of applicable regulations, ethical standards, and clinical research practices.
Minimal Qualifications:
Bachelor's degree, or allied health or related degree required, or equivalent work experience required
Experience:
Experience as a clinical research coordinator in the clinical research field required 3-4 years Clinical research or related experience required Research and/or work experiences that demonstrate aptitude for research facilitation required
Knowledge Skills and Abilities:
Excellent verbal and written communication skills.
Strong communication and organizational skills.
Proficient computer skills.
This position has a hiring range of USD $65,062.00 - USD $117,291.00 /Yr.
