Medical Screening Manager

 

Charles River Clinical Services is looking for a

Medical Screening Manager

BASIC SUMMARY:  

Responsible for managing Screening, Consenting and related functions. Plan, manage and monitor department workload to ensure timely availability of qualified participants to meet study needs. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

· Ensure study participant enrollment goals are met by analyzing screening volume and processes and collaborating with appropriate departments. 

· Oversee documentation and maintenance of all medical services databases.

· Ensure study participant satisfaction by coordinating and conducting study evaluations, including participant feedback sessions.

· Review and understand all contracted study protocols assigned to team and be familiar with investigational drug, particularly the side effect profile.

· Remain apprised of current FDA regulations, OSHA regulations and practices and GLP/GCP guidelines and changes. Communicate this information to department staff and ensure compliance with regulations and recordkeeping requirements.

· Assist in preparation, conduct and follow-up for all sponsors, FDA, IRB or other regulatory audits.

· Interview and select qualified exempt- and non-exempt level departmental personnel.  Recommend, review and approve personnel actions, including hiring, promotions and raises.  Partner with Human Resources in the handling of disciplinary issues.  Prepare and/or approve appropriate personnel action paperwork. 

· Identify training and development needs of direct reports.  Develop and oversee the implementation of departmental training programs, including orientation; monitor training programs to ensure ongoing effectiveness.

· Monitor performance of direct reports.  Provide regular coaching and counseling.  Prepare and deliver salary and performance reviews; review and approve performance and salary appraisals initiated by direct reports.

 

QUALIFICATIONS:

 

· Education:  Bachelor’s degree (B.A./B.S.) or equivalent in a health, scientific or related field.

· Experience:  Previous supervisory/management experience required.  Strong business management background and experience in a research unit, service management organization, contract research organization or medical office setting.  Previous experience desired in any of the following: protocol development, clinical conduct of study, report writing, project management or pharmacokinetics.

· An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

· Certification/Licensure: None.

· Other:   Must have excellent oral and written communication skills and a detailed, analytical, and organized orientation.  Demonstrated professional manner in dealing with co-workers, investigators, and clients.  Demonstrated ability to carry out project planning and assignments independently, assess problematic situations and recommend solutions.  Collaborative working style and the ability to work effectively in a team-oriented environment.  Demonstrated working knowledge of a clinical research center or research site environment, including regulatory requirements regarding the protection of human subjects through informed consent, adverse event reporting and institutional review boards, FDA/OSHA regulations, and GCP/GLP guidelines.  Must be able to prioritize and manage multiple projects.  Solid computer skills, especially word processing and spreadsheets.  Ability to maintain company and sponsor confidential documentation.