Clinical Affairs Specialist III

Thermo Fisher Scientific•Carlsbad, CA

4d•Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. This position is part of the Regulatory and Clinical Affairs organization, which ensures that the internal and external work performed to develop our in vitro diagnostics is in compliance with Good Clinical Practice, applicable regulatory requirements (domestically and internationally), and is submitted to the FDA in a complete, accurate, and timely manner for approvals in support of the business units.

Requirements

Bachelor's degree in Biology, Chemistry, bioengineering, or related science required.
2 years working in the In Vitro Diagnostic or Medical Device Industry.
2 + years of demonstrated experience with managing in-house and/or external clinical studies.
Working knowledge of Good Clinical Practices (GCP) is required.
If certification is not in place, classwork or coursework in Good Clinical Practices is required.
Experience working with multi-functional project teams is required.
Computer literacy, including spreadsheet, database (EDC), and word-processing applications, is required.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screen.

Nice To Haves

In Vitro diagnostic experience is a plus.
Certification as a Clinical Research Professional (CCRP) is a plus.

Responsibilities

Coordinating and conducting activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.
Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements.
Collect all clinical study essential documents.
Participate in lab assessment visits.
Ensure that CRO activities and timelines align with project requirements.
Implement and document communication with CRO and laboratories to ensure project progress.
Real-time escalation of clinical study issues to Clinical Study Managers.

Benefits

Competitive remuneration
Annual incentive plan bonus
Healthcare
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO)
10 paid holidays annually
Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
Accident and life insurance
Short- and long-term disability
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount