Clinical Research Associate

Clinical Research Associate at Thermo Fisher Scientific

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 global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

Our Clinical Operations team is searching for an experienced Clinical Research Associate (all levels)!

Position Overview

The Clinical Research Associate performs and coordinates different aspects of the clinical monitoring and site management process. This role involves conducting remote or on-site visits to assess protocol and regulatory compliance and managing required documentation. You will manage procedures and guidelines from various sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that trials are conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. Ensuring audit readiness and developing collaborative relationships with investigational sites are key responsibilities. Detailed tasks and responsibilities assigned to the role are outlined in the task matrix.

Essential Functions

• Monitors investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions to ensure compliance and decrease risks.
• Ensures data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review as applicable through on-site and remote monitoring activities.
• Assesses investigational product through physical inventory and records review.
• Documents observations in reports and letters in a timely manner using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.
• Maintains regular contact between monitoring visits with investigative sites to confirm protocol adherence, resolution of identified issues, and timely data recording.
• Conducts monitoring tasks in accordance with the approved monitoring plan and participates in the investigator payment process.
• Ensures shared responsibility with other project team members for issues/findings resolution and investigates/follows-up on findings as applicable.
• Participates in investigator meetings as necessary and may help identify potential investigators in collaboration with the client company.
• Initiates clinical trial sites according to relevant procedures to ensure compliance with protocol, regulatory, and ICH-GCP obligations, making recommendations where warranted.
• Performs trial close-out and retrieval of trial materials.
• Ensures required essential documents are complete and in place, according to ICH-GCP and applicable regulations, and conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the team as required.
• Ensures study systems (e.g., Clinical Trial Management System) are complete, accurate, and updated per agreed study conventions.
• Facilitates effective communication between investigative sites, the client company, and internal project teams.
• Responds to company, client, and applicable regulatory requirements/audits/inspections.
• Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in the preparation of project publications/tools and sharing ideas/suggestions with team members.
• Contributes to other project work and initiatives for process improvement, as required.

Keys To Success

Education and Experience:

• Bachelor's degree in a life science-related field.
• Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years independent on-site monitoring experience as clinical research monitor) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care, or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
• Proven understanding of ICH-GCP, EU, and FDA requirements.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Outstanding communication, collaboration, organizational, and time management skills.
• Fluent in English and Turkish.
• Valid driver's license where applicable.
• In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient.

Knowledge, Skills, Abilities:

• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents.
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Good interpersonal skills and ability to maintain customer focus.
• Good organizational and time management skills.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Well-developed critical thinking skills, including critical mindset, in-depth investigation for appropriate root cause analysis, and problem-solving.
• Ability to manage Risk Based Monitoring concepts and processes.
• Ability to work in a team or independently as required.
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills.
• Must be based in Türkiye.

Why Join Us?

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

What We Offer

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 organization but with a local feel.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Key skills/competency

• Clinical Monitoring
• ICH-GCP
• Regulatory Compliance
• Site Management
• Risk-Based Monitoring
• Data Accuracy
• Medical Terminology
• Clinical Trials
• Protocol Adherence
• SOPs