FSP Sr CRA (Level I) Switzerland

ThermoFisher Scientific FSP Sr CRA (Level I) Switzerland in Remote, Germany

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.

PPD Clinical Research Services are currently hiring for experienced client dedicated CRAs to join our team in Switzerland.

Responsibilities:

1. Performs and coordinates all aspects of the clinical monitoring and site management process.
2. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
3. 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.
4. Develops collaborative relationships with investigational sites.
5. Monitors investigator sites with a risk-based monitoring approach applying root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions.
6. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
7. Documents observations in reports and letters in a timely manner using approved business writing standards.
8. Brings up observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.
9. 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.
10. Conducts monitoring tasks in accordance with the approved monitoring plan.
11. Participates in the investigator payment process.
12. Ensures a shared responsibility with other project team members on issues/findings resolution.
13. Investigates and follows-up on findings as applicable.
14. Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
15. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS).
16. Participates in investigator meetings as necessary.
17. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
18. Ensures trial close out and retrieval of trial materials.
19. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
20. Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
21. Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

Education and Experience:

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years as a clinical research monitor).

Valid driver's license.

Full Right to work in Switzerland.

Fluency in English language.

Knowledge, Skills, Abilities:

1. Effective clinical monitoring skills.
2. Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
3. Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents.
4. Well-developed critical thinking skills, including but not limited to: critical attitude, in-depth investigation for appropriate root cause analysis and decision-making.
5. Ability to handle Risk Based Monitoring concepts and processes.
6. Effective oral and written communication skills, with the ability to communicate effectively with medical personnel.
7. Strong attention to detail.
8. Effective organizational and time management skills.
9. Ability to remain flexible and adaptable in a wide range of scenarios.
10. Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software.

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

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.