Lead Clinical Research Associate

Dokumeds is looking for multiple, highly motivated and proactive full time employees or contractors, located in either PL, RU, UA, LV, LT or EE and willing to develop together with the company in position of Lead Clinical Research Associate for large multinational clinical studies in Europe.

Lead Clinical Research Associate (Lead CRA) acts as a primary liaison between Clinical Research Associates (CRAs) and Project Manager (PM with a purpose to streamline project team activities and ensure compliance with Protocol, Monitoring plan and other project specific requirements, Good Clinical Practice (GCP), relevant ICH guidelines and country specific regulations.

Main responsibilities:

  • Oversight of assigned CRAs’ activities to ensure the conduct of the trial in accordance with applicable procedures and regulations
  • Development of study specific procedures, tracking tools and training materials
  • Ensure delivery of applicable training(s)/ re-training(s) to CRAs
  • Maintenance of study specific trackers up to date, monitoring of KPIs and metrics
  • Review of site visit reports
  • Coordination of issue reporting, risk assessment and implementation of corrective and/ or preventive actions
  • Assistance to PM in communication with Sponsor, other departments and groups within Company, Vendors and Competent Authorities
  • Act as a back-up for PM/ designee during the absence

Requirements:

  • University degree in medicine, pharmacy, nursing or biology
  • At least 3 years of clinical trial experience in pharmaceutical, device, biotech or CRO setting
  • Experience in Senior Clinical Research Associate position in pharmaceutical, device, biotech or CRO setting
  • Proactive driver with ability to make decisions, be accountable, achieve set goals and high-quality results
  • Strong leadership (including conflict management), organizational, interpersonal and communication skills, with an ability to prioritize and manage work for a team
  • Excellent knowledge of English language
  • Computer literacy

We offer:

  • Flexibility in contractual relations: employment, project based or freelancer contract
  • Competitive remuneration depending on experience and seniority level
  • A job with daily exciting challenges in a highly qualified team
  • Professional growth in Clinical Research field
  • Friendly work environment
To apply for this position email us your CV along with a cover letter to cv@dokumeds.com.