BD (Becton, Dickinson and Company) Clinical Data Coordinator in Franklin Lakes, New Jersey
Job Description SummaryThe Clinical Data Coordinator (CDC) will support data management activities for BD clinical studies, including start-up, maintenance, and completion activities. The primary objective of this position is to ensure that the study team and clinical study sites are kept apprised of the study status and outstanding issues that require attention. The CDC facilitates information sharing across the various functional groups. He / she will assist with data management activities including: development of CRF Completion Instructions, assisting in CRF design, annotated CRFs, database testing, conducting data review, query generation/resolution, electronic data reconciliation, and maintenance of all study files.
Essential Job Functions:
Generate status reports and distribute to the study team and clinical study sites as appropriate.
Follow-up with study team members and study sites as appropriate on outstanding items.
Assist with the CRAs preparation for on-site monitoring activities.
Assist with the development of CRFs and CRF Completion Guidelines to serve as an aid for site personnel to complete the CRFs.
Perform user acceptance/database testing to ensure the quality and integrity of the clinical study database design and associated edit check programming prior to the study database being released to collect data.
Conduct data review and associated query generation/resolution.
Reconciles data from third party sources (i.e. Lab data) with the clinical study database and communicates discrepancies to the appropriate parties.
Maintains accurate and complete study records including filing, archiving, inventory of study documents, and shipping to other locations.
Performs routine audits of study files and security records to ensure compliance with Clinical Standards.
Experience with MS Word, Excel and PowerPoint.
Highly organized with the ability to manage multiple activities concurrently.
Effective communication skills both verbal and written.
Establishes rapport and collaborates with other (internal and external) team members; builds constructive and effective relationships.
Ability to travel up to 10% of the time.
Additional Desirable Qualifications Skills and Knowledge:
Understands clinical research process and regulatory requirements.
Able to acquire and apply new technical skills.
Identifies problems, issues, and delays; proactively escalates as appropriate to minimize the impact to the project.
Follows through on all tasks and ensures quality results.
Education and/or Experience:
High School diploma required, undergraduate degree preferred from an accredited program.
1 or more years Clinical Research experience or equivalent industry experience, certification or training.
Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work LocationUSA NJ - Franklin Lakes
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.