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.
Location/Division Specific Information
Performs and coordinates different aspects of the clinical monitoring and site management process. This home-based position requires candidates to currently live in one of the following states:
Discover Impactful Work:
Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
A day in the Life:
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Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
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Assess investigational product through physical inventory and records review.
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Raises observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
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May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that identified issues are being resolved and that the data is being recorded.
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Participates in investigator meetings. Initiates clinical trial sites to ensure compliance.
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Performs trial close out and retrieval of trial materials. Conducts on-site file reviews.
Keys to Success:
Education
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Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Experience
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Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials may be considered.
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Valid driver's license where applicable.
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In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities
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Ability to attain and maintain a solid understanding of ICH GCPs and applicable regulations and procedural documents
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Good oral and written communication skills, with the ability to communicate effectively with medical personnel
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Ability to maintain customer focus through the utilization of good listening skills and attention to detail
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Good organizational and time management skills
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Ability to remain flexible and adaptable in a wide range of scenarios
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Well-developed critical thinking skills and problem solving
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Ability to manage Risk Based Monitoring concepts and processes
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Ability to work in a team or independently as required
Physical Requirements / Work Environment
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
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Able to work upright and stationary for typical working hours.
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Able to perform successfully under pressure while prioritizing and balancing multiple projects or activities.
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May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
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This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.
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As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
Benefits
The salary range estimated for this position is $XX hourly/annually - $XX hourly/annually. 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:
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A choice of national medical and dental plans, and a national vision plan
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A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA)
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Tax-advantaged savings and spending accounts and commuter benefits
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Employee assistance program
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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
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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!
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.
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