Clinical Research Associate; m​/f​/d – Part-Time; FTE | Germany

Clinical Research Associate (m/f/d) – Part-Time (0.8 FTE) | Germany Beginn

• Biologe/Biologin

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 department defines, develops and delivers clinical programmes. 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 implement high-quality, cost-efficient clinical studies.

This opportunity is open to experienced Clinical Research Associates across Germany. The role can be home-based, office-based in Munich or Karlsruhe, or hybrid, and is offered as a permanent part-time position (0.8 FTE / 80%).

Performs and coordinates all aspects of the clinical monitoring and site management process.

Conduces remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.

Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.

Develops collaborative relationships with investigational sites.

Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Travel up to 50-75%

Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.

Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.

Assess investigational product through physical inventory and records review.

Documents observations in reports and letters in a timely manner using approved business writing standards.

Brings up observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.

May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.

Conducts monitoring tasks in accordance with the approved monitoring plan.

Participates in the investigator payment process.

Ensures a shared responsibility with other project team members on issues/findings resolution.

Investigates and follows-up on findings as applicable

Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.

Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS).

Performs QC check of reports generated from CTMS system where required.

Participates in investigator meetings as necessary.

Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial…