CLINICAL SAFETY ASSOCIATE / 40 HOURS / DAY / BWH - TIMI
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POST DATE 8/11/2016
END DATE 3/22/2017
Brigham & Women's Hospital(BWH)
JOB DESCRIPTIONGENERAL SUMMARY/OVERVIEW STATEMENT:
The Clinical Safety Associate will evaluate, review, and approve serious adverse event reports from worldwide clinical sites participating in
TIMI Study Group trials in accordance with FDA and ICH guidelines, and Safety Management Plans.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1.Process domestic and foreign safety reports received from assigned studies, according to ICH-GCP guidelines, regularity requirements,
TIMI SOPs, and departmental policies and procedures.
2.Exercise judgment to assess incoming case reports and source documentation for seriousness and, completeness, accuracy, legibility, and
consistency of information and perform necessary checks for duplicate cases.
3.Serve as a liaison to external contacts such as investigational sites, field monitors, and other study staff around the world to obtain missing,
discrepant or additional information/source document for each case using medical and regulatory knowledge
4.Collaborate with internal colleagues from Operations, Regulatory and QA, Data Management, CEC, and Scientific Staff (this is done to
resolve issues and queries on cases).
5.Interact with Medical Staff to ensure appropriate medical review and assessment is provided for assigned case reports.
6.Maintain required documentation of all activities associated with securing information and producing reports.
7.Manage department service standards and turnaround times related to processing submission to the sponsor, expedited reviews, and query
8.Participate with identification and implementation of process improvement opportunities of the department.
9.Maintain professional standards of conduct with particular attention to personal/behavioral, staff team work, and customer-staff interaction
10.Perform other duties and/or special projects as required and appropriate.
Bachelors degree required
Degree in Nursing, Pharmacy or health-care related field preferred
3 years drug safety experience or in a clinical trial related position required
Working knowledge of ICH/GCP Guidelines
1. MedDRA/WHO Drug Coding is strongly recommended
2. Demonstrated high level proficiency in MS office products (Word and Excel).
3. Preferred but not required proficiency in Adobe Acrobat and EDC applications.
4. Sound attention to detail.
5. Strong organizational skills.
6. Strong sense of responsibility and an ability to work autonomously, as well as act as a strong team player.
7. Displays ability to understand established procedures and communicate those procedures to others.
8. Sound ability to communicate effectively in a matrix environment.
9. Solid written and oral communication skills.
10. Ability to multi-task.
Busy office environment with frequent deadlines
Brigham and Womens Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without
regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, ancestry, age, veteran status, disability unrelated to
job requirements, genetic information, military service, or other protected status.
Brigham and Womens Hospital I CARE Standards
The I CARE Standards guide me in my interactions with patients, family members, visitors, colleagues, and neighbors in my workplace and
surrounding community to optimize the Brigham experience and help fulfill my role in our mission of providing seamless, high quality patient and
family centered care.
C.I will Communicate my commitment to high quality performance
A.I will Appear and act as a professional
R.I will Respect all individuals
E.I will Extend myself