SCIRENT Clinical Research and Science is seeking a motivated Senior Clinical Research Associate for a full-time position in Germany, ideally based in Berlin or willing to relocate to Berlin. Candidates must be fluent in English and German, with experience in Regulatory Affairs (RA) required. Proficiency in an additional language (Greek, Italian, or a Scandinavian language) would be advantageous. The ideal candidate should also be willing to take on project-related management tasks.

___

Your area of responsibility

Study Oversight: Lead coordination of multiple study centers, ensuring compliance with clinical protocols and regulatory standards, specifically targeting cardiovascular research.

Clinical Risk Management: Identify and manage clinical risks associated with cardiovascular trial procedures and patient safety.

Team Leadership and Training: Mentor CRA teams, emphasizing best practices and protocol adherence in cardiovascular research.

Stakeholder Communication: Act as the principal communicator between the study site, sponsors, and regulatory agencies, focusing discussions around cardiovascular study objectives.

Audit Preparation and Compliance: Ensure cardiovascular study sites are prepared for audits and maintain strict compliance with cardiovascular-specific regulatory requirements.

Clinical Documentation: Oversee the documentation and reporting process, ensuring accurate and timely follow-up of adverse events and serious adverse events related to cardiovascular issues.

Regulatory Support: Assist with regulatory filings and communications, specifically related to cardiovascular studies, maintaining compliance with local and international guidelines.

___

Your profile

Education: Bachelor’s degree or higher in a clinical, scientific, or health-related field, ideally with a specialization in cardiology or cardiovascular medicine.

Experience: Significant experience as a Clinical Research Associate required. Familiarity with cardiovascular clinical trials is an advantage but not mandatory.

Certifications: ICH/GCP trained, with additional qualifications in cardiovascular research preferred.

Skills: Strong leadership and organizational skills, excellent communication abilities, and adept at problem-solving within cardiovascular clinical settings.

Language Proficiency: Fluent in English and German. Additional languages (Greek, Italian, or a Scandinavian language) are beneficial.

Personal Traits: Proven ability to work both independently and as part of a team, committed to advancing cardiovascular health through rigorous clinical research.

___

-more-

Extra: attractive salary and a company pension scheme

Onboarding: Welcome trips to our partner countries, newcomers meet & greet - we ensure your perfect start

Training: Your development is important to us. We offer in-house training in all areas of clinical research. There is the possibility of voluntary language courses or regular coaching - we will keep you up to date!

Work equipment: We offer offices all over Europe, a laptop, telephone.

Accessibility: Our modern office right in the heart of Berlin is easy to reach thanks to its perfect location

SCIRENT was founded in 2012 with the vision of helping customers develop innovative medical drugs and devices for patients with cardiovascular diseases. Our dedicated team of experienced clinical and regulatory professionals share their enthusiasm for developing effective therapies for cardiac patients. What sets us apart from our competitors is our profound expertise in cardiovascular therapy and diagnostics. Our CRO offers access to an impeccable network of dedicated trial centers in Europe and North America with extensive experience in cardiovascular studies. Our customers appreciate our lean and agile management, which generally makes our performance faster and more efficient.

We are looking forward to receiving your complete application documents, stating the possible start of work.

___

CEO: Prof. Dr. med. Hans-Dirk Düngen

SCIRENT Clinical Research and Science

Amrumer Str. 16, 13353 Berlin

www.scirent.com

Job Type: Full-time

Ability to commute/relocate:

• 13353 Berlin: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Auf welchem Sprachniveau sind Sie in Deutsch nach GER? (A1, A2, B1, B2, C1 oder C2)
• What is your proficiency level in English according to the CEFR? (A1, A2, B1, B2, C1, or C2)

Experience:

• CRA: 2 years (Required)

Language:

• german (Required)
• english (Required)

Work Location: In person