FSP Clinical Trial Coordinator

Thermo Fisher Scientific•Wilmington, NC

39d

About The Position

The Clinical Trial Coordinator provides administrative and technical support to project teams and supports assigned clinical trial activities according to the applicable task matrix. The role helps maintain audit readiness by reviewing files on schedule and documenting findings, supports site activation and feasibility activities, and ensures assigned work is completed on time, within budget, and to a high-quality standard. The coordinator maintains trial systems and databases, supports trial documentation and communications, and proactively communicates risks to project leads. Responsibilities may vary by whether the role is Central or Local. The coordinator may assist with site selection and tiering, regulatory submissions, site document collection, feasibility surveys, Investigator Site Files and Pharmacy binders, translation materials, and coordination with internal departments and sites. The role may also provide system support, support risk-based monitoring activities, train new personnel, and contribute to global feasibility processes and best practices.

Requirements

High school or secondary school diploma or equivalent, plus a relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 1 year; an appropriate combination of education, training, and/or directly related experience may be accepted as an equivalency.
Ability to work independently or as part of a team.
Good organizational skills, strong attention to detail, and the ability to handle multiple tasks efficiently and effectively.
Ability to analyze project-specific data and systems to ensure accuracy and efficiency.
Strong customer focus and flexibility to reprioritize work as project timelines change.
Ability to attain and maintain working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs relevant to project implementation, execution, and closeout.
Good English language and grammar skills, with proficient local language skills as needed.
Good computer skills, proficiency in MS Office (Word, Excel, and PowerPoint), and ability to learn and master clinical trial database systems.
Ability to successfully complete the organization's clinical training program.
Self-motivation, a positive attitude, and good interpersonal skills.
Effective oral and written communication skills.
Judgment and decision-making skills.
Ability to accurately follow project work instructions.
Good negotiation skills and independent thinking.
Ability to manage risk and escalate risks appropriately.

Nice To Haves

Bachelor's degree preferred.

Responsibilities

Coordinate, oversee, and complete assigned trial activities according to the task matrix and the specific Central or Local role.
Conduct assigned department, internal, country, and investigator file reviews and document findings in appropriate systems.
Complete allocated tasks on time, within budget, and to a high-quality standard; proactively communicate risks to project leads.
Provide system support, including for Activate and eTMF, and keep system databases current.
Perform trial administration, including processing documents for the client eTMF, conducting eTMF reviews, distributing mailings and communications, and providing documents and reports to internal team members.
Analyze and reconcile study metrics and findings reports, and assist with clarification and resolution of site documentation findings.
Assist with coordination, compilation, and distribution of Investigator Site File and Pharmacy binder materials and non-clinical study supplies to sites.
Assist with study-specific translation materials and translation quality control when requested.
Maintain knowledge of applicable organization and client SOPs, directives, and regulatory guidelines.
Conduct on-site feasibility visits where applicable in Asia Pacific.
Support scheduling of client and internal meetings where needed.
Review and track local regulatory documents where applicable.
Support risk-based monitoring activities where applicable.
Support study documentation and systems, including study team lists, project-specific training requirements, system access, and project activity plans.
Transmit documents to the client and centralized IRB/IEC, and maintain vendor trackers.
Support the start-up team with regulatory submissions and work directly with sites to obtain site-selection documents.
Assist the project team in preparing regulatory compliance review packages.
Coordinate with internal departments to align site start-up activities with the site activation critical path.
Complete the Site Interest Plan in CTMS where applicable and collect and deliver associated documents from investigators and site personnel.
Document communications, contact attempts, and follow-up related to site contacts and survey responses in real time.
Review survey data to ensure responses are logical, complete, and responsive to the questions asked.
Collaborate with teammates to meet project deadlines and communicate site issues and risks to the team and appropriate clinical personnel.
Ensure an effective site contact and follow-up plan is in place, comply with the plan, and escalate concerns or non-compliance to management.
Where applicable, serve as a local expert on site capacity and experience, gather local knowledge, recommend additional sites, and contribute to local site tiering.
Liaise with Global Investigator Services to resolve investigator queries promptly and maintain account and contact information.
Contribute to the development and rollout of global strategic feasibility processes and best practices.
Train new personnel in processes and systems.
Use local knowledge to help identify and develop new sites.