A Drug Safety Coordinator job in Clayton, NC is currently available through Belcan at one of our key pharmaceutical clients. To be considered for this role, you will have an Associates degree or higher and two to three years of experience in a clinical setting. Experience with Drug Safety is highly desired. In this role, you will be responsible for obtaining and processing all appropriate information regarding adverse events and product technical complaint data to maintain a thorough and strict adherence to Good Clinical Practices (GCP), regulatory guidelines, and company SOPs. You will assist Drug Safety Scientist (DSS) in building team environment among assigned staff and between other departments. This is a long-term 6+ month contract position, which will include a full benefits package, including paid holidays and PTO time.
Drug Safety Coordinator Job Duties:
Enters the case into the tracking log and place the case in the appropriate folder.
Enter the case into the tracking log, check whether it is an initial, a follow-up, or a duplicate report and place the case in the appropriate folder.
Create a new folder for an initial case and label it, delete all confidential patient information from the received report, record protocol number and site/patient number, if applicable, on all source documents and provide the report to the person conducting case evaluation
Enters data into safety database. Ensures accurate entry. Performs electronic or manual coding, as necessary, according to project specific guidelines.
Enter Product Technical Complaint into the Trackwise database.
Scan, copy and upload documents for attachment into database
Support other drug safety team members with faxing reports, narratives and queries. Place confirmations into the appropriate folder.
Take meeting minutes when required
Serves as Drug Safety team member for Global Drug Safety projects.
Maintains a thorough understanding of the protocol and scope of work for clinical studies.
Assists DSS with adverse event follow-up and case closure
Communicates problems and issues to Director/DSS in a timely manner.
Actively participates in DS project team meetings, providing process improvement suggestions. Adheres to required timelines for completion of adverse event and product technical complaint reports.
Maintains a thorough understanding and strict adherence to GCP guidelines and regulatory reporting regulations.
Associate Degree and 2-3 years of recent experience in a clinical setting or equivalent in experience or training.
Data entry into an Oracle AERS database preferred.
Excellent technical skills required, including the ability to comprehend and integrate scientific data from a variety of sources.
Comprehensive knowledge of medical terminology required.
Excellent interpersonal skills, flexibility, organizational skills, attention to detail, ability to prioritize, and computer literacy required.
The ideal applicant will have the ability to lead short presentations in a small group setting while tracking initial and follow up adverse event information.
If you are interested in this Drug Safety Coordinator job in Clayton, NC, please apply via the \"apply now\" link provided.
Belcan is a global supplier of engineering, technical recruiting, and IT services to customers in the aerospace, industrial, and government sectors. Belcan engineers better outcomes through adaptive and integrated servicesfrom jet engines, airframe, and avionics to heavy vehicles, chemical processing, and cybersecurity. Belcan takes a partnering approach to provide customer-driven solutions that are flexible, scalable, and cost-effective. Our unique capabilities have led to continuous growth and success for nearly 60 years. We are a team-driven Equal Opportunity Employer committed to workforce diversity.
Associated topics: clinical, emr, environmental, inspector, risk, safety, sewer system, scba, treatment, usda