Clinical Research. /Data Associate

Rhytec, Inc. is an innovative and rapidly growing medical device company specializing in the field of Dermatology and Plastic Surgery. We offer a competitive compensation package for highly motivated individuals.

U. S. Citizenship or a valid work permit is required for all positions. Rhytec, Inc. is an Equal Opportunity Employer. Visit our website at www.rhytec.com

Clinical Research/Data Associate

The Clinical Research/Data Associate is responsible for assisting the Clinical Research Manager in developing the data management processes and meeting corporate goals. The ideal candidate will possess experience in both Clinical Research and Data Management positions. Position growth will be based on performance. Clinical Research/Data Associate will work with project team to ensure successful completion of trials in accordance with current federal regulations and SOPs. The successful candidate must be capable of wearing many hats and therefore must be flexible and task oriented. Self-starter who can work relatively independently is strongly desired.
REQUIREMENTS
Data Responsibilities:
The Clinical Research/Data Associate is responsible for providing accurate and documented clinical databases that will be used for analysis of study results and possible presentation to regulatory agencies. You will be relied on to ensure the clinical database accurately reflects the data collected from the clinical sites. Primary responsibilities include:
?Assisting with the creation of Data Management SOPs
?Implements Quality Control procedures for Data Management.
?Initiates corrective action as appropriate and resolves data discrepancies with appropriate personnel in Clinical.
?Preparation of case report forms based on clinical protocols
?Creation and management of databases according to SOPs and Federal Regulations
?Receipt and tracking of case report forms
?Case report form review and query creation and tracking
?Data Entry and File maintenance
?Preparing data for final study report
?Preparing data for submission to various regulatory authorities
?Receiving photos and maintaining photo database for each study

Clinical Responsibilities:
?Liaise with current customers who are interested in Investigator Initiated Trials
?Assist IITs with protocol and case report form development
?Act as primary contact for Investigators throughout IIT process
?Maintain communications on a regular basis with the investigator and/or his/her assigned contact.
?Communicate findings from contact reports and monitoring visits to appropriate staff in a timely manner.
?Assure adequate reporting of adverse events, protocol deviations, and patient status.
?Maintenance of trial master file/site files and related database, as well as photo database


Skills, Education and Experience:
?Bachelors degree in health related discipline.
?Good interpersonal and communication skills (verbal and written).
?Self motivation, attention to detail and organizational skill are key to success.
?Must have excellent working knowledge of MS Word, Excel and Access.
?At least one year experience in working with Investigator Initiated Trials
?Knowledge of the principles of good clinical data management.
?Strong analytical and organizational skills and willing to work in a fast paced environment.
?Strong knowledge of FDA Regulations, 510K and IDE studies and Good Clinical Practices.
?Excellent communication skills and able to interface with multifunctional team members and present information in concise and effective manner.