FSP Clinical Trial Coordinator II East Coast

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Purpose of the position

• Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies
• Executes tasks as assigned by the CPM related to the conduct of clinical studies study budget forecasting and tracking
• Responsible for collecting tracking and supports reporting of research related Transfer of Value (TOV) to enable compliance with Transparency reporting requirements (US and EU)
• Responsible for ensuring study documentation (including trial master files study related contracts and financial level documentation) and study documentation is processed maintained / archived in compliance with ICH-GCP Company policy and procedures. Includes liaison with service providers in regard to the e-TMF process and resolving issues related to missing documentation
• Performing QC checks on TMFs to ensure completeness and readiness for audit / inspection
• Contributes to clinical trial excellence initiatives

Main responsibilities and tasks :

Be responsible for setting-up monitoring verifying and archiving the clinical Trial Master File (TMF)

Be responsible for follow- up and review of financial documents in collaboration with CRM / CPM

Responsible for tracking collecting and disclosure of expenses in compliance with regulations in force : EFPIA disclosure code (Europe) Sunshine Act (US)

Responsible for data entry and status updates within the Clinical Trial Management System (CTMS)

Coordinate and conduct in-house and external clinical operations activities

Other missions to the position

EHS responsibilities :

Experience / Qualifications

Experience :

Qualification :

Previous experience that provides the knowledge skills and abilities to perform the job (comparable to atleast 3 years).

Language :

Key Required Technical Competencies

Compensation and Benefits

The hourly pay range estimated for this position based in North Carolina is .

This position may also be eligible to receive a variable annual bonus based on company team and / or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes :

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 and short- and long-term disability in accordance with company policy

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

For more information on our benefits please visit : Experience :

IC

Key Skills

CSS,Cloud Computing,Health Education,Actuary,Building Electrician

Employment Type : Full-Time

Experience : years

Vacancy : 1