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DOCS Clinical Research Associate (m/w) in United States

Clinical Research Associate (m/w)

Ref #: 26813

Employment type: Permanent - Full-Time

Location: Home based in southern Germany

Posted: 10-Feb-2021

Description

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 a Clinical Research Associate (m/w) to work closely with one of the most successful pharmaceutical companies. If you are a CRA 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 for studies of all phases (I, II, III, IV and NIS) in a range of different indications (Focus on oncology)

• 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.ICONplc.com/FSP or timo.kindermann@docsglobal.com. We are looking forward to your application.

#CRA

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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