Clinical Operations Director

About Us

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

Responsible for the overall management of operations carried out at site.

Essential Responsibilities And Duties

 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.

 Responsible for staff personnel hiring and training.

 Attends and conducts meetings to assure proper execution of accepted protocols.

 Assists with the development, revision, and implementation of Standard Operating

Procedures.

 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. The following are study-related activities:

 Assists with negotiating contract terms with Business Development Dept. team.

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 Assists with the acquisition of qualified Investigators and sites, in cooperation with the

Business Development.

 Ensures all Sponsor visits are conducted in accordance with site policy.

 Determines staffing needs and makes Study Coordinator and Research Assistant

assignments.

 Oversees enrollment according to agreed upon contracts.

 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.

 Oversees The DEA Files. This Includes The Following

 Ensures DEA 222 forms are ordered and well accounted for (where applicable).

 Conducts all DEA site visits.

 Keeps DEA files separate and locked at all times.

 Assumes other duties and responsibilities as assigned. The above responsibilities are a

general description of the level and nature of the work assigned to this classification and are

not to be considered as all inclusive.

Education/Experience/Skills

 Must be able to effectively communicate verbally and in writing.

 Must have experience in organizational management.

 Must have experience in the clinical research industry.

 Must have experience in protocol development and training staff on protocol execution.

 Must have the ability to communicate effectively, both verbally and in writing.

 Must have experience in managing staff and implementing personnel procedures.

 Must reflect the professional image of the company, upholding the company vision in

actions, demeanor, and appearance.

Working Conditions

• Indoor, Office environment.
• Essential physical requirements include sitting, typing, standing, walking.
• Lightly active position, occasional lifting of up to 20 pounds.
• Reporting to work, as scheduled, is essential.
  
  

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for

employment without regards to race, color, religion, sex, sexual orientation, gender identity, national

origin, veteran, or status