Coordinates and oversees clinical trial activities, including drafting and negotiating budgets and contractual terms with study sites. Manages administrative tasks such as eTMF reviews, site documentation, and ensuring compliance with regulatory guidelines and SOPs.
Requirements summary
Requires a high school diploma or equivalent, with a bachelor's degree preferred and 0 to 2 years of relevant experience. Candidates must possess strong organizational skills, knowledge of ICH GCP, and proficiency in MS Office.
Work Schedule Standard (Mon-Fri) Environmental Conditions Office
Job Description
Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 bioteches, spanning 2,700 clinical trials across 100+ countries in the last 5 years. What You’ll Do:
According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
Drafts, reviews, negotiates and finalizes amendments and budgets with study sites in accordance with local/accepted process.
Negotiates within approved parameters both investigators grant budget negotiation parameters, contractual terms and conditions in accordance with contractual considerations, client contractual considerations, established process with clients and follows established escalation routes.
Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
Ensures compliance to established negotiation parameters, authority approval, contractual process and client expectations.
Ensures compliance of budgetary guidance, templates and process.
Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensures alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation.
Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Assists with study-specific translation materials and translation QC upon request.
Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Where applicable, conducts on-site feasibility visits (Asia Pac only).
Documents in real time all communication, attempts an follow up associated with site contact and survey responses.
Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked. Education and Experience Requirements:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
Bachelor's degree preferred.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 year). 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
Ability to work in a team or independently as required
Basic ability to apply basic principles of investigator grant negotiation.
General understanding of business and financial principles that related to service agreements.
Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
Strong customer focus
Flexibility to reprioritize workload to meet changing project timelines
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, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
Ability to successfully complete the organizations clinical training program
Self-motivated, positive attitude and good interpersonal skills
Effective oral and written communication skills
Good interpersonal skills
Essential judgment and decision-making skills
Capable of accurately following project work instructions
Good negotiation skills
Independent thinker
Ability to manage risk and perform risk escalation appropriately 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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