Senior Clinical Research Associate - Oncology Experience Required

3 days ago

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KCR

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KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations.

Clinical Monitoring • Functional Service Provider • Site Set up and Contracting • Late Phase • Medical & Regulatory Affairs

501 - 1000

Description

• Performing site visits and monitoring activities in accordance with protocol, GCP/ICH Guidelines and other applicable requirements. • Ensuring overall integrity of study and adherence to guidelines, protocol and regulations. • Taking an active role in the project team by providing feedback and suggestions for successful completion of the project. • Leading, coaching and mentoring CRAs team to assist in their development and training. • Responsible for execution of KPI`s for assigned staff and for all site deliverables within required time and budget. • Providing 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%

Benefits

• 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.