Clinical Study Coordinator

CLINICAL STUDY COORDINATOR

COMPANY INFO:

MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries.  We specialize in the nationwide recruitment of clinical trials personnel.

 

Our client develops, produces and markets instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the skeleton and its soft tissues and is seeking to add a Clinical Study Coordinator to their team in West Chester, PA.

 

JOB SUMMARY:

Under the direction and supervision of senior clinical trials staff, responsible for the support and conduct of assigned clinical trials. Assists the Clinical Trials staff in maintaining accurate records. Maintaining an up-to-date database of patients and site participation.

 

RESPONSIBILITIES:

- The Clinical Study Coordinator must be capable of functioning with a minimum of direction and have the capability to determine what information is necessary to perform a given task, obtain such information and then execute the activity

- The CSC will communicate at established intervals and as necessary with their assigned investigational sites to effectively manage activities at that site.  This communication is to include, but is not limited to subject enrollment issues, patient follow-up, action items generated from monitoring visits, if queries have been resolved and radiograph tracking

- The CSC will maintain the study specific logs in a timely and accurate manner. These tools will then be used in tracking and communicating issues to the investigational sites as well as reporting activities to the Manager, Clinical Affairs. 

- The CSC will help maintain the Central Study Files

- All activities performed by the CSC must be compliant with the relevant regulatory and company requirements

- Participate in special projects as needed

- Other duties as assigned

- Strong attention to detail

- Good oral and written communication skills

- Ability to work on several projects simultaneously

 

QUALIFICATIONS:

- Familiarity with medical terminology

- Knowledge of Clinical Trials helpful

- Knowledge of FDA medical device regulations helpful

- Experience using electronic data capture or similar databases helpful

- Computer Software experience including but not limited to Microsoft Office (Word, Excel and Power Point)

 

 EDUCATION:

- An Associate degree, Bachelor's degree preferred

 

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.