healthcare
Posted 3 hours agoClinical Research Coordinator II - Flowood
Flowood, United StatesOn-site
Responsibilities
- Independently coordinate and manage industry-sponsored clinical trials from study start-up through closeout with minimal supervision
- Manage complex study visit schedules and protocol-related activities while ensuring adherence to study timelines and requirements
- Lead patient recruitment and retention efforts including chart review, patient outreach, informed consent discussions, and enrollment tracking to support study enrollment goals
- Conduct protocol-required patient visits and assessments in accordance with study protocols, GCP guidelines, and site SOPs
- Perform protocol-required clinical procedures including vital signs, ECGs, specimen collection, investigational product accountability, and phlebotomy, as permitted by applicable regulations, training, and organizational policy
- Process laboratory specimens and prepare shipments in accordance with protocol
- Maintain accurate, complete, and timely study documentation including source records, informed consent forms, CTMS updates, and case report forms
- Ensure high-quality data entry and timely resolution of data queries in accordance with sponsor expectations and established timelines
- Maintain ongoing communication with sponsors, CROs, investigators, site leadership, and internal teams to proactively resolve study-related issues
- Prepare for and support sponsor, CRO, and regulatory monitoring visits, audits, and inspections
- Review safety reports and ensure appropriate investigator review and documentation in a timely manner
- Maintain inventory and organization of study equipment, supplies, and investigational products onsite
- Support the protection of human research participants in compliance with federal regulations, GCP, HIPAA, and institutional policies
- Perform job related duties as requested
Requirements
- By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
- By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need.