Senior Site Compliance Specialist

Work Schedule

Environmental Conditions

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 – To enable 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.

Alongside clinical research through our PPD clinical research portfolio, our work in Accelerated Enrollment Solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.

Position Summary: Provides quality control to the clinical trial process by ensuring all study documentation and source data is accurate and up to date and data is entered into the eCRF in a timely manner. Performs quality control reviews and answers any CRF queries in a timely manner. Assists as a Team Lead and mentor junior compliance coordinators.

Key Responsibilities:

• Acts as a core operational Data Coordinator on several studies to ensure the successful delivery of client data on all studies.
• Collaborates daily with the team lead. Assists team lead with the training and mentorship of junior team members.
• Serves as first point of contact for junior team member questions, concerns and clarifications.
• Remotely participates in the start-up and close out of projects, ensuring adherence to the client and company expectations.
• Ensures accurate and timely entry of all data in the eCRF from the source notes and tracks the flow of the CRFs, queries and reports on the flow of data.
• Ensures patient visits are within visit windows, as per protocol, and reports deviations.
• Ensures prompt response within agreed timeframes to data clarification requests.
• Identifies quality issues (QI), potential data breaches and reports it as required.
• Ensures SOP & COPs are adhered to and gives clarity and guidance to others in the implementation thereof.
• Ensures adherence to rules and regulations of ICH, GCP and other regulatory and ethical guidelines as well as data protection regulations.
• Identifies trends in data queries.
• Provides guidance on functional GCP and other compliance and quality related topics, as required, to improve quality and expertise.
• Identifies training needs of junior staff and provides training (i.e. data systems) and assists with induction of new site staff.

Education Requirements:

• Bachelor’s degree or equivalent and relevant formal academic/vocational qualification.

Experience:

• Previous applicable experience that provides the knowledge, skills, and abilities to perform the job.

Knowledge, Skills, Abilities:

• Professional knowledge of theory and techniques in the data and compliance field.
• Strong ability to multi-task and have oversight over numerous studies with a variety of therapeutic areas and size simultaneously.
• Firm knowledge in all types of audit preparations, including sponsor and internal audits.
• Ability to provide oversight during audits.
• Above average industry knowledge of quality compliance and GCP regulations.
• Excellent interpersonal, leadership and consultation skills.
• Good working knowledge of Business English.
• Strong MS Office and computer skills.
• Good medical terminology knowledge.
• Excellent time management skills.
• Solid attention to detail.

Working Conditions and Physical Requirements:

• Work is performed in a (home) office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.
• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple 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 with regular multi-tasking.

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.

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.

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