Clinical Trial Coordinator- GPHS

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 lifechanging 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.

Location/Division Specific Information

The position is based onsite in Bethesda Maryland.

Discover Impactful Work:

The preferred candidate will have government support experience and clinical trial experience. Provide administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed aids the development of site activation and develops collaborative relationships with investigators and site personnel. Supports training of new staff and participates in departmental initiatives to aid in process improvements/enhancements.

A day in the Life:

• Coordinates with clinical staff to plan implement monitor and manage clinical protocols with Internal Review Board (IRB) requirements.
• Assists with protocol assembly development and review of trial documents.
• Collaborates with clinical staff to develop and maintain trial related documents and operational procedures.
• Plans implements monitors and manages clinical protocols with IRB requirements.
• Reviews protocol data for entry in protocol database.
• Creates databases and coordinates data collection.
• Oversees the collection distribution and filing of regulatory documents
• Other duties as assigned

Education

Bachelors degree inLife Sciencesor other related discipline.

Experience

Three 3 years of experience in a related field. Experience in the fundamentals of clinical trials. Expertise in the operation of computerand general data acquisition programs. Familiarity with IRB requirements.

Knowledge Skills Abilities

• Strong organizational skills and attention to detail with proven track record to handle multiple tasks efficiently and effectively
• Proven ability to effectively analyze projectspecific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
• Good presentation skills
• Excellent digital literacy proficient in MS Office (Word Excel and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
• Selfmotivated positive attitude with effective strong interpersonal skills
• Effective oral and written English communication skills with the ability to communicate effectively with medical personnel
• Excellent interpersonal skills
• Strong attention to detail and quality of documentation
• Good digital literacy and the ability to learn appropriate software
• Basic medical/therapeutic area and medical terminology knowledge
• Ability to work in a team environment or independently.
• Ability to attain and maintain a solid understanding of GCP and applicable SOPs
• Proven flexibility and adaptability
• A proven relationship builder
• Ability to manage risk and perform risk escalation appropriately

Physical Requirements / Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Work is performed in a home office environment with exposure to electrical office equipment.

Physical Requirements:

• Frequently stationary for 46 hours per day.
• Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists.
• Ability to access and use a variety of computer software developed both inhouse and offtheshelf.
• Ability to communicate so others will understand; with the ability to listen to and understand information and ideas.
• May interact with others relating and gathering sensitive information. Interaction includes diverse groups.
• Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multitask.

The salary range estimated for this position is $20.00 hourly $36.00 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)
• Taxadvantaged 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 longterm 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 100000 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!

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*. 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 nondisability related technical issues will not receive a response.

Compensation and Benefits

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 longterm 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:

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