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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll 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.

**Objectives/Purpose** :

The Clinical Trial Coordinator (CTC) will perform tasks related to planning and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.

+ Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the Functional Service Provider (FSP) Manager and in collaboration with CTA Manager(s)

+ Collaborate with Clinical Operations/Study Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.

+ Perform departmental tasks as needed.

Accountabilities:

For assigned business critical, non-critical or and/or regional studies, provide support for study activities, including but not limited to:

+ Review of study documentation, including essential document packets, study plans, informed consent forms, etc.

+ Supporting/oversight of risk-based monitoring.

+ Attendance of key team meetings as required, including Minutes for selected studies

+ Supporting regulatory inspection readiness (e.g. SOP Lists, storyboard collation.)

+ Support clinical trial systems (e.g. CTMS/TMF associated activities for selected studies.

+ Supporting vendor contract administration as required.

+ Support study close-out activities, e.g. financial reconciliation

+ Supporting additional ad-hoc activities as needed, as agreed with Manager(s).

For all assigned studies, provide support including:

+ Collaboration with internal departments (Legal, Insurance, R&D functions, etc.), CROs, and external vendors.

+ Supporting vendor contract administration as required.

Provide support for departmental tasks, including but not limited to:

+ Maintaining knowledge of systems and processes.

+ Attending internal and external trainings as needed and maintaining up-to-date training record.

Core Elements Related To This Role:

The Clinical Trial Coordinator (CTC) will perform tasks related to supporting planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. The CTC will provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under supervision of the CTC Manager. The CTC will collaborate with FSA and Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the operating model. The CTC will also perform departmental tasks as needed.

Dimensions And Aspects:

+ Understanding and application of GCP, ICH, and applicable regulatory standards governing clinical research.

+ Comfortable with technology and able to learn new systems quickly.

+ Strong knowledge of MS Word, Excel, PowerPoint, and Outlook.

Decision-Making And Autonomy:

+ Ability to work in a fast-paced environment with demonstrated ability to manage multiple

+ competing tasks and demands.

+ Ability to work with timelines and complete tasks according to deadline.

+ Problem solving study-related issues; escalation of issues as needed.

Interaction:

+ Must be able to professionally interact and communicate with internal departments (Legal,

+ Insurance, R&D functions, etc.), CROs, and external vendors.

+ Ability to effectively collaborate with both internal and external study team.

+ Ability to work in a matrix environment.

+ Coordination with external vendors as needed.

Complexity:

+ Requires strong attention to detail in composing and/or proofreading and/or approving study

+ materials, establishing priorities, scheduling, and meeting deadlines.

+ Ability to take ownership and manage tasks, as well as communicate effectively.

+ More than one study and/or more than one program may be assigned.

+ Interactions with study teams and other colleagues are both local and remote (in varying

+ locations and time zones).

Education, Behavioral Competencies And Skills:

Education:

+ Bachelor’s degree or equivalent international degree required.

Experience:

+ 1-2 years’ experience in pharmaceutical industry, clinical research organization.

+ Experience in Phase 2 and 3 studies and global/international studies is advantageous.

+ Experience working across multiple therapeutic areas (including oncology) is advantageous.

Skills:

+ Knowledge in global/regional regulatory and compliance requirements for clinical research.

+ Demonstrated excellence in task management and cross-functional collaboration.

+ Excellent communication skills.

+ Excellent teamwork, organizational, interpersonal, and problem-solving skills.

+ Fluent business English (oral and written).

The salary range estimated for this position is $20.00 hourly - $23.00 hourly, dependent on leveling. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.

We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:

+ A choice of national medical and dental plans, and a national vision plan

+ A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA)

+ Tax-advantaged savings and spending accounts and commuter benefits

+ Employee assistance program

+ 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, and volunteer time off in accordance with company policy

+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!** **http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability** **Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Compensation and Benefits

The hourly pay range estimated for this position Clin Ops Delivery Associate I based inNorth Carolina is $45,000.00–$47,000.00.

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: https://jobs.thermofisher.com/global/en/total-rewards

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.