Assistant CRA (ACRA) - Germany in Karlsruhe bei Thermo Fisher Scientific

Thermo Fisher Scientific

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.

Location/Division Specific Information

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD, part of Thermo Fisher Scientific— thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

At PPD, part of Thermo Fisher Scientific, we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Discover Impactful Work:

As an Assistant CRA, you will perform remote site management and monitoring activities on assigned project(s) in accordance with FDA and/or local regulations and guidelines, ICH GCPs and company 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. Current PPD CRAs qualify to be considered for this role without having the degree requirements.