This role will be responsible for managing clinical trials from startup to closeout by coordinating site operations:
Responsibilities and Duties:
- Manage the entire clinical trial cycle: site assessments, pre-trial assessments, site initiation, subject recruitment and retention, monitoring, and close-out.
- Direct staff: recruitment, training, compliance, travel, scheduling and coverage, evaluations, discipline, and terminations.
- Oversee all required study startup documentation and timelines on assigned study protocols.
- Collaborate with corporate teams to ensure staffing, start-up, and trial goals are met.
- Maintain effective, courteous and ongoing communication with staff, sponsor, research participants, and PI during the course of trials.
- Ensure enrollment goals of trials are met.
- Oversee training for all protocols as well as requirements for regulations.
- Support the team and investigators in overall conduct of trials.
- Ensure monitoring visits and sponsor/FDA audits are completed successfully.
Experience and Skill Requirements:
- At least 4 years of clinical research coordinator experience, including 2 years of management experience at a clinical research organization.
- Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred.
- Ability to multi-task, adhere to deadlines, and work both independently and cooperatively with interdisciplinary teams.
- Strong computer skills in relevant software and related clinical systems are required.
- Comprehensive knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
- Solid teamwork, organizational, interpersonal, and problem-solving skills and attention to detail.
- Strong verbal and written communication skills, preferably bilingual (Spanish).”