Assistant CRA - Belgium

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 department defines, develops and delivers clinical programmes. We ensure the highest-quality review of data and effective interaction with study sites, including on-site monitoring throughout a study, ensuring that patients receive needed care, as well as identifying and treating clinical trial participants.

We currently have an opportunity for an Assistant CRA to join our Clinical Operations department in Belgium. The role could be either office, hybrid, or home based anywhere in Belgium.

As an Assistant CRA, you will perform remote site management and monitoring activities on assigned project(s) in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and PPD procedural documents by reviewing study data from various sources remotely. You will contact study sites to collect study documentation, resolve issues and request outstanding information.

A day in the Life:

• Develops and maintains a close and collaborative communication with the site staff. Actively discusses protocol conduction, enrollment rates and strategies, open issues, EDC completion and queries, as well as any other topic or indicator associated to project status and site performance.
• Completes/tracks/follows up ETRTR for subject data present in the EDC and other applicable systems, according to the study-specific guidelines. Raises manual queries in EDC when applicable.
• Remotely reviews study logs as deemed necessary.
• Conducts and documents site management calls/contacts according to the monitoring plan. Participates in investigator meetings. Investigates and follows-up on centralized monitoring findings.
• Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes to assess site’s ability to conduct study on a regular basis. Conducts remote investigations into site performance using a risk based monitoring approach: applying root cause analysis (RCA), critical thinking and problem-solving skills to help identify site process failure and work on corrective/preventive actions to bring the site into compliance and decrease risk.
• Provides refresher training, follows up on outstanding administrative needs (e.g., outstanding/updated regulatory documents), assists with regulatory reviews, as requested, etc.
• Reviews ad-hoc clinical listings review, tracks and trends violations and deviations, site status, enrollment, CRF status and SAE follow up.
• Provides trial status tracking and progress update reports to study manager.
• Participates in the investigator payment process, if applicable.
• Liaises with internal staff to promptly collect documents, review data points and findings from EDC and file reviews, etc.
• Assists in ensuring audit ready files and complying with CTMS and eTMF data stewardship. Contributes to company, client, and federal/local regulatory requirements/audit responses.
• Detailed task assignment and responsibilities are outlined on the task matrix, as well as any applicable protocol guidelines.

Keys to Success:

Education:

• Bachelor’s Degree in a life science-related field OR Registered Nurse license along with an Associate’s Degree in Nursing.

Experience:

• Prior clinical research experience 0-1 year as well as knowledge of clinical monitoring through classwork/training that provides the required knowledge skills and abilities.
• In some cases, previous experience in a clinical environment where experience is gained in clinical trials, data management, medical terminology, medical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
• Prefer individuals who aspire to advance into a CRA role.

Knowledge, Skills, Abilities:

• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Fluency in English, French and Dutch
• Ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and PPD procedural documents
• Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP)
• Ability to successfully complete the RSM Onboarding Workshop
• Ability to evaluate medical research data
• Ability to advise, counsel, and motivate investigational sites
• Effective oral and written communication skills with the ability to communicate effectively with medical personnel
• Excellent interpersonal and customer service skills
• Good organizational and time management skills
• Proven flexibility and adaptability
• Strong attention to detail
• Ability to work in a team or independently, as required
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Ability to coach and mentor site personnel.
• Good computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable.
• Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards

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 anaward-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.

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.