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Director of Clinical Research
1 month ago
The ideal candidate will have experience in the management of multi-center sites, multi-center studies, and clinical trials, with strong interpersonal, communication, and project management skills. They should be comfortable interacting with individuals at all levels of clinical research from research assistants and Principal Investigators to patients enrolled in the study. The individual should be able to manage a large research team, provide them with guidance, and jump in to help complete tasks when needed. This position ensures adherence to all applicable regulations, Good Clinical Practices, and industry standards governing research involving human subjects; and ensures that clinical studies are performed with the utmost integrity and quality.
Job Responsibilities Meet or exceed enrollment targets, annual budgeted revenue, and expense targets.
Interact positively with the clinical portion of practice and with RCA Research.
Maintain general operations of the research department involving day-to-day operations.
Manage staffing needs including professional development, hiring, training, and coaching/mentoring staff.
Coordinate and manage appropriate training for research staff.
Perform and approve employee performance reviews and provide feedback to motivate employees dedication to professional goals.
Provide mentorship and guidance to team members and cross-functional staff on study processes and requirements.
Manage site workflow to ensure that patients/subjects, staff, and sponsors have the best customer service experience.
Oversee study management including timely review of monitor reports and associated study deliverables.
Oversee site study audits and inspections as needed.
Identify, assess, and work with the RCA QA team to resolve site performance and quality/compliance issues.
Coordinate and manage various tasks with the RCA QA team & Regulatory Manager to achieve site readiness for timely first patient visit.
Obtain and maintain an in-depth understanding of study protocols and related procedures to contribute to the study team's knowledge by sharing best practices and providing training as needed.
Ensure sites meet monthly screening, randomization, and completion/retention goals by assessing scheduling, troubleshooting, and maximizing staff availability.
Oversee research accounting and financial management of the research department including incoming payments, employee expense reporting, research payroll approval, and authorizing research expenditures.
Follow a quality process as outlined in the Site's/RCAs SOPs to ensure the site collects and enters high-quality data and reduces preventable deviations.
Ensure the site has high morale, works well as a team, and meets our cultural goals and expectations.
Coordinate with the general clinic Manager to ensure effective integration of clinical research and regular clinical patient care.
Required Skills and Qualifications Bachelors Degree Preferred.
Ophthalmic Experience Preferred.
7+ years of clinical research operations management-level experience preferred.
Excellent knowledge of ICH GCP guidelines; CCRP certification preferred.
Experience in people management and management best practices is required.
Experience in managing operations of multi-site research centers.
Skills/Competencies Strong experience in clinical research and staff management.
Able to hire, train, and develop staff.
High degree of organization and planning: Plan, organize, schedule in an efficient, productive manner, focusing on key priorities.
A strong work ethic: Willing to step in to assist the team when needed.
A team player who can receive and provide constructive feedback.
The ability to motivate and inspire a team to function at its highest capacity.
Excellent verbal and communication skills.
Excellent organization skills and attention to detail.
Strong supervisory and leadership skills.
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