Clinical Data Associate (International Travel a must)

Systex, Inc. is a growing Federal Government contractor providing Information Technology (IT) services for the National Institutes of Health for over 40 years. We are currently seeking qualified candidates for a mid-level Clinical Data Associate position to provide data management services and support clinical research studies of emerging diseases as part of a multidisciplinary rapid response team.  The position will work on-site in Rockville, Maryland with the potential for remote work.

Responsibilities:

· Clinical Research Data Management Process Development & Operations.

· Responsible for ensuring timely and accurate data management practices.

· Communicate issues to Data Management Lead.

· Participate in quality management processes.

· Support data management workflows and meet project timelines as required.

· Participate in core clinical trial data tasks including but not limited to:

o   Data Entry & verification

o   Data QC & Review

o   Listing Review

o   Site Query Process

o   Validation Lead Potential

o   Validate DB Entry Screens

o   Validate Edit Checks

o   Validate Listings        

o   CRF design

o   Test Plan creation

o   CRF review    

o   Create edit checks      

o   Create DMP documents        

o   Point of contact for country DM team

o   Special Project Appointments

o   Provide team training 

o   Provide Site training  

o   Provide support initiatives

· Maintain strong communication within the data management and study operations team.

· Familiarity with REDCap, DFDISCOVER or other CDMS.

· Domestic and international travel possible (no more than 10%) to resource-limited countries.

Desired Experience:

· Bachelor’s Degree in healthcare informatics, clinical, biological or mathematical sciences or related field or equivalent work experience.

· 2+ years data management experience in a clinical research environment.

· Familiarity of the data management process (e.g., serious adverse event reconciliation, management of local laboratory data) and understanding of data management operating procedures.

· Knowledge of clinical research regulations including Good Clinical Practices and relevant regulatory guidelines.

· Working knowledge of clinical research operations, clinical trials, medical terminology, and/or pharmacology.

· Willing to travel domestically and internationally (10%) and must have or able to acquire valid passport.