Director of Clinical Operations

CenExel•Decatur, GA

9d•Onsite

About The Position

Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Independently Manages study operational plans to include project timelines and quality of deliverables. Manages the planning, organization, and daily operations of the clinical and administrative activities of a complex research site. Develops, implements, and monitors programs, policies and procedures to ensure the highest quality of participant and sponsor satisfaction.

Requirements

Must be able to effectively communicate verbally and in writing.
Must have a minimum of three to five years experience in a leadership role in the clinical research industry.
Ability to understand company financials and strategic planning.
Must have experience in protocol development and training staff on protocol execution.
Must have experience in managing staff and implementing personnel procedures in a clinical research setting.
Must reflect the professional image of the company, upholding the company vision in actions, demeanor, and appearance.

Nice To Haves

Bachelor's degree in related field or equivalent experience is preferred.
Master’s Degree Preferred.

Responsibilities

As a member of the management team, assists in evaluating operational practices and providing recommendations, as needed.
Serves as an official representative of the company when dealing with sponsors, organizations, governmental agencies, etc.
Maintains receptivity to new ideas and opportunities to improve the company’s operations and services, referring information to other staff for consideration and response.
Attends and conducts meetings to assure proper execution of accepted protocols.
Supervises staff and is responsible for overseeing performance evaluation, and termination of staff in accordance with site personnel policies.
Oversees study enrollment and contract timelines.
Has responsibility for the efficient management of each contracted study. Specific tasks related to studies may be delegated.
Attends and participates in strategic and financial planning meetings.
Ensures all Sponsor visits are conducted in accordance with site policy.
May determine staffing needs and makes Clinical Research Coordinator and Research Assistant assignments.
Interfaces with Sponsors/Investigators throughout the terms of their agreements.
Ensures study records are maintained and protected.
Ensures all regulations are followed throughout the conduct of the study.
Coordinates with appropriate departments to comply with internal and external audits.
Oversees the processes related to controlled substances and DEA files.
Hires, trains, supervises, and evaluates personnel.
Champions and enforces the strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site Working Practices, protocol, and company guidelines and policies.
Retrains and implements corrective and preventative actions, as needed.
Assumes other duties and responsibilities as assigned.