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.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. 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.
Summarized Purpose:
Provides compliance support to the clinical trial process by ensuring all study documentation and source data is captured accurately in eCRF, up to date and first time right. Performs quality reviews and answers any eCRF queries in a timely manner. Reviews accuracy of the Investigator Site Files (ISF) as well as performs quality compliance checks and answering any CRF queries in a timely manner.
Essential Functions
Act as the primary point of contact for sponsors representative.
Maintains ISF and study trackers as delegated and ensures that ICFs are correctly completed.
Completes data capturing activities on one or more studies across multiple sites and regions.
Ensures accurate and timely entry of all data in the eCRF from the source notes and tracks the flow of the eCRFs and queries.
Verifies protocol visit windows are correct according to the protocol requirements and reports deviations.
Assists monitors and sponsor representatives with query resolutions after monitoring visits.
Interprets and adheres to company SOP and COP and assists with input during the review process.
Adheres to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations.
Assists with drafting compliance reports.
Assists with archiving procedures as needed.
Liaises frequently with monitors and client representatives. Performs preparation of monitoring visit duties and clarifies any expectations relating to CRFs.
Supports audit preparation and ensures audit readiness.
Identifies and escalates common data errors and trends and may assist with CAPA and problem solving methods.
Job Complexity: Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
Job Knowledge: Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
Supervision: Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Exercises judgment within defined procedures and practices to determine appropriate action.
Business Relationships: Contacts are primarily internal to the company with infrequent external customer/ vendor contact on routine matters. Builds productive internal / external working relationships.
Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
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 and Abilities:
Professional knowledge of theory and techniques in the data and compliance field
Ability to multi-task and have oversight over numerous studies with a variety of therapeutic areas and size simultaneously
Knowledge of all types of audit preparations and 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
Good MS Office and computer skills
Basic medical terminology knowledge
Solid time management skills
Strong attention to detail
Management Role: No management responsibility
Working Conditions and Environment:
Work is performed in an office or clinical environment with exposure to electrical office equipment.
Occasional drives to site locations. Frequent travel both domestic and international.
Physical Requirements:
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.
Frequent mobility required.
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 access and use a variety of computer software developed both in-house and off-the-shelf.
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.
Frequently interacts with others to obtain or relate information to diverse groups.
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. Ability to multi-task.
Regular and consistent attendance.
Accessibility/Disability Access
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
EEO & Affirmative Action
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
