Senior Clinical Research Associate

Senior Clinical Research Associate

Coloplast has an exciting opportunity for a Senior Clinical Research Associate to join our growing team!

 

This position is a member of the clinical study team supporting all research activities and is responsible for driving and managing clinical studies to support marketing and regulatory needs.  The Senior Clinical Research Associate acts as a primary communication liaison between the company and customers participating as investigational sites on clinical studies.  This position will provide site management and ensure activation, data collection, and data cleaning are completed per the study timeline.  This position will complete site monitoring to comply with regulations and will ensure clinical activities comply with organizational SOPs and regulatory requirements.  The Senior Clinical Research Associate represents Coloplast during physician site visits

 

Major Areas of Accountability
  • Contribute to development of clinical investigation plans, monitoring plans, data management plans and site-facing regulatory and subject documentation
  • Contribute to vendor selection, qualification and ongoing vendor relationship management
  • Conduct site qualification and initiation visits
  • Independently manage site selection, qualification and initiation visits
  • Negotiate contracts
  • Responsible for site management, and may conduct monitoring visits
  • Contribute to clinical database development.  Process and review clinical study data using Good Clinical Practices and data-handling procedures
  • Support development of study reports
  • Support development of clinical strategy; including Clinical Evidence Plans (CEP) and Clinical Development Plans (CDP)
  • Support development of abstracts and publications
  • Act as clinical representative on cross-functional product development team
  • Contribute to oversight of study-specific safety reporting
  • Drive procedure process development and improvement
  • Conform with Coloplast Code of Conduct and all local Compliance Standards
  • Conform with Coloplast Q/EHS Policy
  • Other duties as assigned

 

Basic Qualifications
  • 4+ years of experience in clinical research, preferably with medical devices
  • Bachelor’s degree (preferably in health science areas)
  • GCP Knowledge/Knowledge of US regulatory requirements for trial related activities
  • Extensive experience in site management
  • Experience in monitoring FDA regulated trials
  • Ability to travel 30%

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

 

Visit us on Coloplast.com.

Watch the film. Follow us on LinkedIn. Like us on Facebook.

 

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

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