The Clinical Safety Data Entry Associate (DEA) I/II are responsible for the intake of Serious Adverse Event (SAE) information received from clinical investigational sites. He/She will be responsible for the preparation and compiling of source SAE documents to include but not limited to the following:
1. Creation of the initial SAE file (electronic or paper) and folders.
2. Retrieval of SAE source documents including or printing screen shots of eCRF pages from a clinical database .
3. Redaction of confidential patient information from source documents
4. Data entry of SAE information into the database.
5. Attachments of SAE source documents and correspondence into the safety database or electronic folders including posting of reports and deliverables.
6. Tracking of initial and follow-up information requests.
7. File organization, archiving and management.
The DEA requires high level of attention to detail, and accuracy in entering SAE information obtained from various source documents. The DEA ensures that case information is entered and source documents posted on time within the CS timelines and as specified for each study. The DEA uses the most updated site, vendor and Sponsor contact information during case entry. Typical data entry may include but not limited to information on reporter, patient, serious adverse events, investigational products, medical history, labs and procedures and concomitant medications, etc. The DEA maintains security and confidentiality of safety information at all times.
Job Requirements :
He/She must demonstrate understanding and adherence to the Clinical Safety standard operating procedures, guidelines and work instructions.
Data entry maybe assigned additional responsibilities that involve the timely delivery of SAE documents to HCRI study affiliates and/or sponsors.
Experience entering information into a database including document management.
Ability to multitask and handle competing timelines.
Completes assignments on time.
Demonstrates good organizational skills.
Demonstrates understanding of drugs, biologics and medical device guidelines and reporting.
Experience with Safety Database and/or Clinical Database highly desirable
Knowledge of medical terminology desirable
Clinical Safety and/or Clinical Research experience desirable
High School Diploma required, College degree in life sciences preferred
Proficiency with Word and Excel application
Knowledge of Visio and MS Access
Demonstrate good communication skills and professional demeanor
Be a team player.