Clinical Research Project Coordinator
3 weeks ago
At Thermo Fisher Scientific, you will engage in impactful work that contributes positively on a global scale. Our mission is to empower our clients to enhance health, safety, and cleanliness worldwide. We equip our teams with the necessary resources to fulfill personal career aspirations while advancing scientific endeavors through the research, development, and delivery of transformative therapies. With clinical trials taking place in over 100 countries and the continuous evolution of innovative frameworks for clinical research through our PPD clinical research portfolio, our efforts encompass laboratory, digital, and decentralized clinical trial services. Your commitment to delivering quality and precision will enhance health outcomes that individuals and communities rely on now and in the future.
Discover Meaningful Contributions:
Provide administrative and technical assistance. Ensure audit preparedness by reviewing files in accordance with the schedule outlined in the organization's standard operating procedures and departmental guidelines. Assist in developing the critical path for site activation within assigned projects to facilitate rapid site activations. Represent the organization within the global medical research community. Potentially cultivate collaborative relationships with investigators and site personnel to conduct feasibility assessments in line with established processes and timelines. May build a local knowledge base of sites in the respective market through collaboration with local personnel. May utilize local insights, organizational systems, external site lists, and sponsor directives to create and evaluate site lists that align with the strategic needs of feasibility activities and contribute local insights into the site tiering process. May serve as a mentor during the onboarding process. Support the training of new personnel and engage in departmental initiatives aimed at process enhancements.
A Day in the Life:
- Conduct department, internal, country, and investigator file reviews as assigned, documenting findings in the appropriate systems.
- Ensure that assigned tasks are completed on schedule, within budget, and to a high-quality standard, proactively communicating any risks to project leads.
- Provide system support (e.g., Activate & eTMF) and maintain current databases.
- Perform administrative duties on assigned trials, including timely processing of documents sent to Client (e)TMF, conducting (e)TMF reviews, distributing communications as necessary, and providing documents and reports to internal team members.
- May assist in scheduling client and/or internal meetings.
- May review and track local regulatory documents.
- Maintain vendor trackers.
- Support the start-up team in regulatory submissions.
- Collaborate directly with sites to obtain documents related to site selection.
- Work alongside teammates to achieve targeted objectives for assigned projects, connecting with the team and relevant clinical personnel regarding site issues and risks.
- May conduct phone interviews, scripted or unscripted, with physicians and other site personnel to discuss standard of care and gather protocol-level input to support trial optimization projects.
Keys to Success:
Education:
- High school diploma or equivalent, with relevant formal academic or vocational qualifications. A Bachelor's degree is preferred.
Experience:
- Prior experience that provides the knowledge, skills, and abilities necessary to perform the job (comparable to at least 2 years).
Knowledge, Skills, Abilities:
- Ability to work effectively in a team or independently as required.
- Flexibility to adjust workload priorities to meet changing project timelines.
- Demonstrated ability to maintain a solid understanding of applicable country regulations, ICH Good Clinical Practices, and organizational/client standard operating procedures and working practice documents.
- Proficient English language and grammar skills, along with necessary local language skills.
- Strong digital literacy, proficient in MS Office (Word, Excel, and PowerPoint), and capable of mastering all clinical trial database systems.
- Effective oral and written communication skills.
- Sound judgment and decision-making abilities.
- Capable of accurately following project work instructions.
What We Offer:
At PPD Clinical Research Services, we prioritize hiring the best talent, fostering personal and professional development, and recognizing the strength of teamwork. We understand your desire for growth throughout your career, and at PPD, you will benefit from an award-winning learning and development program designed to help you reach your potential.
In addition to a competitive salary, we offer a comprehensive benefits package focused on the health and well-being of our employees. We promote a flexible working culture that values work-life balance. Our organization has experienced sustainable growth year after year while maintaining a collaborative environment where colleagues are eager to share expertise and enjoy working together. We are a global organization with a local feel.
Our mission is to empower our clients to create a healthier, cleaner, and safer world. As part of a team of over 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working collectively to accelerate research, tackle complex scientific challenges, drive technological advancements, and support patients in need.
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