FSP Clinical Trial Coordinator I - Onsite at THERMO FISHER BIOPHARMA SERVICES PTE LTD

Indianapolis, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

30 May, 26

Salary

0.0

Posted On

01 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Organizational Skills, Attention To Detail, Data Analysis, ICH Good Clinical Practices, SOPs, WPDs, English Language, Microsoft Office, Google Suite, Clinical Trial Database Systems, Risk Escalation, Customer Focus, Communication Skills, Independent Thinking, Decision-Making, Project Coordination

Industry

Biotechnology Research

Description

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. Division Specific Information Our global Clinical Research Group (CRG) colleagues within the Functional Service Partnership (FSP) solutions area provide support for clinical trials during feasibility, study start up, maintenance, close out, and database lock, depending on the client’s needs. Client-dedicated Clinical Trial Coordinators (FSP CTCs) work directly with clients to provide administrative and technical support by performing day-to-day functions within the client organization to support clinical trial activities. In the FSP CTC role, you will represent PPD, part of Thermo Fisher Scientific, while working alongside the client, as a partner, providing a specific service. This role is also referred to as a "Records Management Associate". Tasks can include providing administrative and technical support to the client study team; supporting client audit readiness by ensuring client systems are accurate and up to date; providing administrative support for site activation activities; and managing assigned service providers and/or vendors. FSP CTC roles and responsibilities may vary based on client needs. This role is 100% onsite in Greenwood, Indiana (M-F 8am - 5pm). Sponsorship will not be provided. Relocation assistance will not be provided. A Day in the Life: Coordinates with study team during startup, maintenance, and closeout activities to include collection, review, and submission of documents to regulatory authorities Manages and contributes to the electronic Trial Master Files (eTMF) during feasibility, study startup, maintenance, and closeout activities (e.g., collecting and filing documents, uploading study team lists, adding/updating study site information, study milestones and other important data) Performs eTMF quality and completion checks and initiates follow-up on resolutions when needed Assists with feasibility and site selection activities Manages study system access for study team, site staff, and service providers/vendors Attends internal/external meetings and supports scheduling, agenda and meeting minutes creation/distribution Creates, maintains, reviews and/or distributes study trackers, forms, newsletters, memos to study teams, sites and service providers/vendors Assists study lead with oversight of the client’s service provider(s) to ensure assigned activities are completed accurately and on time (e.g., system completeness, product vendor(s) and site management) Assists with administrative requests for entering purchase orders, change orders and running financial reports, with oversight of study lead May assist with coordination of trial/site insurance, tracking of study supplies and/or shipments of drug supply Attends and/or assists in preparation for in-person meetings, such as Kick Off Meetings (KOMs), Investigator Meetings (IMs), or client Face to Face meetings May assist with additional client administrative projects and tasks as needed, such as supporting onboarding of new study team members Keys to Success: Education High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification. Bachelor’s degree preferred. Experience Previous experience that provides the knowledge, skills and abilities to perform the job. 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 Good organizational skills and strong attention to detail, with shown ability to handle and prioritize/reprioritize multiple tasks efficiently and effectively Shown ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout Good English language and grammar skills and proficient local language skills as needed Good computer skills, including knowledge of Microsoft Office and/or Google Suite Ability to obtain knowledge and master all clinical trial database systems (e.g., Veeva, RAVE, SIP) Ability to identify and escalate risk as appropriate Ability to quickly learn and adapt to client processes and systems (as applicable) Ability to work in a team or independently as required Strong customer focus Self-motivated, positive attitude, and good social skills Effective oral and written communication skills Essential judgment, independent thinking, and decision-making skills Capable of accurately following project work instructions Physical Requirements/Working 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: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensive and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. Travel may be required based on client needs. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. 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. 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.

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Responsibilities

This role involves coordinating with the study team across startup, maintenance, and closeout activities, including document collection, review, and submission to regulatory authorities. Responsibilities also include managing and contributing to the electronic Trial Master Files (eTMF) through filing documents, updating study information, and performing quality checks.