FSP Clinical Trial Coordinator I - Onsite

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.