DM Clinical Research, the largest privately-owned research management organization in the Houston area, is looking for an experienced Site Director. 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 and English).
About DM Clinical Research
DM Clinical Research, the largest privately-owned research management organization in the Houston area and one of the top 50 in the country