Senior Clinical Research Associate/CRA II

4 days ago


Boston, Massachusetts, United States KCR Full time
Job Summary

We are seeking a highly skilled and experienced Clinical Research Associate to join our team at KCR. As a Clinical Research Associate, you will be responsible for performing site visits and monitoring activities in accordance with protocol, GCP/ICH Guidelines, and other applicable requirements.

Key Responsibilities
  • Perform site visits and monitoring activities in accordance with protocol, GCP/ICH Guidelines, and other applicable requirements.
  • Ensure overall integrity of study and adherence to guidelines, protocol, and regulations.
  • Take an active role in the project team by providing feedback and suggestions for successful completion of the project.
  • Lead, coach, and mentor CRAs team to assist in their development and training.
  • Responsible for execution of KPIs for assigned staff and for all site deliverables within required time and budget.
  • Provide leadership for the development and implementation of new training programs and improvement of current programs for assigned staff.
Requirements
  • Bachelor's degree in life sciences/pharmacy/biotechnology, nursing from an accredited US College/University.
  • At least 2 years of independent monitoring experience (including pre-study, initiation, routine monitoring, and close-out visits) according to protocol monitoring guidelines, SOPs, GCP/ICH Guidelines.
  • Deep knowledge of monitoring procedures and entire clinical trial process.
  • Minimum of one (1) year Oncology, Early Phase experience as a CRA.
  • Computer literate, and adaptable to new technologies.
  • Fluent English, written and spoken.
  • Ability to complete tasks in an accurate and timely manner.
  • Ability to travel up to 70%.
What We Offer
  • 33 PTO days (inclusive of recognized holidays) + 1 additional for your birthday.
  • A valuable healthcare and wellbeing benefits package (private health plans, life insurance, travel insurance, disability insurance, private retirement fund) plus additional discount programs.
  • Loyalty and Referral Programs.
  • Onboarding process and induction training to develop deep sector knowledge and complex skills.
  • Latest technology and the most advanced equipment and working tools.
  • An open culture based on slim processes, in an agile structure with a flat hierarchy and direct access to the Management to share ideas and implement change and continuous improvement.
  • Mentoring and training programs related to clinical trials, therapeutic areas, hard and soft skills.
About KCR

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting, and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston, US, Berlin, Germany, Madrid, Spain, and Warsaw, Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities, and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies.

We are committed to fostering an inclusive culture and maintaining a diverse, safe, and respectful working environment with equitable treatment for all. We believe that in developing a desirable culture of belonging in which diverse perspectives and voices are welcomed and heard, the full potential of employees can be achieved.



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