Director of Clinical Research

Full job description

We are looking for an experienced Director of Clinical Research! The ideal candidate will have experience in management of multi-center sites, multi-centers studies, clinical trials and strong interpersonal, communication, and project management skills, as well as 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 to 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 upmost integrity and quality.

Description of Responsibilities :

• Meet or exceed enrollment targets, annual budgeted revenue and expense targets
• Interact in a positive manner with clinical portion of practice and with RCA Research
• Maintain general operations of the research department involving day-to-day operations
• Staff management and proactive assessment of staffing needs to include 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 on their performance to help motivate the employee's dedication to professional goals
• Provide mentorship and guidance to team members and cross-functional staff on study processes and study requirements
• Manage site workflow to ensure that patients / subjects, staff, and sponsors have the best customer service experience
• Oversight of study management including timely review of monitor reports and associated study deliverables
• Oversight of 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 in collaboration with the RCA QA team & Regulatory Manager to achieve site readiness for timely first patient first visit
• Obtain and maintain in-depth understanding of the study protocols and related procedures in order to contribute to the study team knowledge by sharing best practices,
• Making recommendations for continuous improvement and providing training as needed / required
• Ensure site meets monthly screening, randomization, and completion / retention goals by assessing scheduling, troubleshooting, and maximizing staff availability
• Oversight of 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 / RCA's SOP's to ensure the site collects and enters high quality data and to reduce preventable deviations
• Ensure the site has high morale and works well as a team and meets our cultural goals and expectations
• Coordinate with general clinic Manager so assure effective integration of clinical research and regular clinical patient care.

Skills / Competencies :

Strong experience in clinical research and staff management

Able to hire, train and develop staff

High degree of organization and planning : Plan, organizes, schedules 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 details

Strong supervisory and leadership skills

Required Education and Experience :

Bachelor's 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

Benefits :

401(k)

Dental insurance

Health insurance

Paid time off

Referral program

Vision insurance