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.

Our Clinical Operations team within the PPD clinical research business of Thermo Fisher Scientific in the Republic of Georgia, is hiring on full-time permanent position:

Clinical Trial Coordinator (CTC) II

Discover Impactful Work:

The CTC II provides administrative and technical support. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Represents the organization in the global medical research community. May develop collaborative relationships with investigators and site personnel to conduct feasibility assessments in accordance with feasibility processes and within timelines. May develop a local knowledge base of sites in the respective market through collaboratively working with local company personnel. May apply local knowledge, organization systems, external site lists and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. May act as a buddy during onboarding phase. Supports training of new staff and participates in departmental initiatives to aid in process improvements/enhancements.

A day in the Life:

Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.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.May support scheduling of client and/or internal meetings.May review and track of local regulatory documents.Maintains vendor trackers.Supports start-up team in Regulatory submissions.Works directly with sites to obtain documents related to site selection.Works in collaboration with teammates to achieve targeted goals for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.May conduct phone interviews, scripted or non-scripted, with physicians and other site personnel to discuss standard of care and obtain protocol-level input to support trial optimization projects.

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 (comparable to at least 2 years).

Knowledge, Skills, Abilities

Ability to work in a team or independently as requiredFlexibility to reprioritize workload to meet changing project timelinesDemonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDsGood English language and grammar skills and proficient local language skills as neededGood digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systemsEffective oral and written communication skillsCrucial judgment and decision-making skillsCapable of accurately following project work instructions

What we offer:

At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.  

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD Clinical Research Services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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