Clinical Research Associate (m/f)

Employer
Docs Global (Continental Europe)
Location
Germany
Salary
Competitive
Closing date
20 Sep 2020

View more

Discipline
Clinical Research, Clinical Research Associate
Hours
Full Time
Contract Type
Permanent
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Summary:

If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in Biotechnology, then here is your chance. DOCS is hiring several Clinical Research Associate's (m/w) to work closely with one of the most successful pharmaceutical companies. If you are a CRA anywhere in Germany willing to work home based and open for a new challenge, we would like to get to know you.

Key responsibilities:

• Ensures clinical study sites are conducting clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and regulations
• Provide input into feasibility, identify clinical investigators and conducts site evaluations post-feasibility to determine site suitability and selection
• Conduct Investigator Profile and Clinical Site Initiation visits as well as Clinical Site Close-Out visits
• Facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans
• Identify site needs and site-related issues, escalate them and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate the clinical trial process
• Ensures appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAEs)
• Facilitate the resolutions of clinical queries to investigative staff in accordance to the study specific monitoring plan
• Report Important Protocol Deviations (IPDs) and develop issue resolution plans
• Review, collect and maintain essential documents, submit to CTA for processing
• Develop site visit plans and conduct monitoring visits
• Prepare reports for Investigator and Site Evaluations, Clinical Site Initiation, Clinical Site Monitoring, and Clinical Site Close-Out
• Assist in preparing sites for audits, review audit reports and contributes to resolve findings
• Build and maintain solid and long-term professional relationships with investigators and site staff
• Mentor new CRAs, as needed (experienced CRAs only)
• Travel frequency of up to 60%

Requirements

• BA/BS/BSc degree or similar
• Familiarity with ICH/GCP guidelines plus local codes of practice as applicable
• Experience working as a CRA (working on industry-sponsored or industry-partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company)
• Attention to detail, organizational skills, time management & prioritization
• Relationship management & influencing skills
• Proficiency in English and German
• Willingness to travel
• Good working knowledge of common software packages
• Flexibility and Team skills

What is offered:

• 100% Home Office
• Permanent contract
• Great work atmosphere in a great team
• Mostly regional travel
• Compensatory time-off
• Contribution to pension scheme
• Company car or car allowance
• Travel time = work time

Why this vacancy is right for you:

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Would you like to know more? Please submit your CV via www.docsglobal.com or timo.kindermann@docsglobal.com. We are looking forward to your application.

#CRAjob

DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry. 

 

Our Values

At DOCS, we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are:

OUR PEOPLE: We attract, source, develop and retain the best talent to enables us provide world-class people and solutions for our clients.

EXCELLENCE: We never stop looking for new, better ways of working.

ACCOUNTABILITY: We take responsibility for our actions, owning our client’s problems and proactively looking for solutions.

INTEGRITY: Becoming a trusted partner means being honest, respectful and ethically sound, at all times.

OPENNESS: We encourage and facilitate an open and inclusive environment for a diverse global network of employees and stakeholders.

Contact Us
  • 2 Globeside
  • Globeside Business Park
  • SL7 1HZ
  • United Kingdom
  • +44 (0) 2380 688500
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