Kelly Services CR34 - Drug Safety Specialist I in Boston, Massachusetts
Clinical Safety Associate
The Clinical Safety Associate will evaluate, review, and approve serious adverse event reports from worldwide clinical sites participating in trials in accordance with FDA and ICH guidelines, and Safety Management Plans.
Principal duties and responsibilities:
Process domestic and foreign safety reports received from assigned studies, according to ICH-GCP guidelines, regularity requirements, TIMI SOPs, and departmental policies and procedures.
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.
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
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).
Interact with Medical Staff to ensure appropriate medical review and assessment is provided for assigned case reports.
Maintain required documentation of all activities associated with securing information and producing reports.
Manage department service standards and turnaround times related to processing submission to the sponsor, expedited reviews, and query follow up.
Participate with identification and implementation of process improvement opportunities of the department.
Maintain professional standards of conduct with particular attention to personal/behavioral, staff team work, and customer-staff interaction guidelines.
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
MedDRA/WHO Drug Coding is strongly recommended
Demonstrated high level proficiency in MS office products (Word and Excel).
Preferred but not required proficiency in Adobe Acrobat and EDC applications.
Sound attention to detail.
Strong organizational skills.
Strong sense of responsibility and an ability to work autonomously, as well as act as a strong team player.
Displays ability to understand established procedures and communicate those procedures to others.
Sound ability to communicate effectively in a matrix environment.
Solid written and oral communication skills.
Ability to multi-task.
If you believe you are a strong candidate for this position and you would like to further your career, please apply now for immediate consideration!
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm