Senior Clinical Trial Associate

3 months ago

Norwood, United States Corbus Pharmaceuticals Full time

Corbus Culture:



Our passion. Our purpose. At Corbus, it starts at our core.

We look for unique talent. Our people are brilliant, they break barriers and are not defined by a title. Eclectic experiences make Corbus a special place to share ideas and grow. At Corbus, transformative ideas can come from anyone, anywhere and anytime. We offer our team flexibility and the opportunity to excel in their professional journey. We provide a welcoming space where collaboration, mentorship and diversity are encouraged. We come together, like no other, to elevate each other and focus on what’s best for patients.



About Corbus



Corbus is a precision oncology company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Our pipeline is comprised of two experimental drugs targeting solid tumors: CRB-701, a next-generation antibody drug conjugate (“ADC”) that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload and CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells. The pipeline also includes CRB-913, a highly peripherally restricted cannabinoid type-1 (“CB1”) receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.

Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer



Job Description



The Senior CTA is a highly-skilled specialist contributing to the development of relevant concepts, techniques and processes by assisting and helping lead the study team across all investigator sites. Based on experience, the Sr. CTA assumes responsibility for more complex tasks and applies creative and effective solutions where needed. Typically working on assignments requiring judgement and initiatives with an understanding of the implications of the work being performed, the Sr. CTA independently identifies tasks/issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing project/corporate priorities. The Senior CTA may act as a team lead or mentor and/or train more junior team members.


This role will be local to Norwood, Ma onsite 3 days a week/remote 2 days a week.



PRIMARY RESPONSIBILITIES:



  • Ensure compliance with protocol and overall objectives across all investigator sites
  • Perform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines
  • Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes
  • Execute study activities according to study protocol, regulatory guidelines and operational plans
  • Review Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures
  • Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards
  • Participate in study start-up, conduct and closeout activities
  • Assist in preparation of vendor requests for proposals and track receipt of proposals, MSAs and SOWs
  • Collect and review site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.)
  • Assemble and distribute regulatory binders to clinical sites
  • Draft and/or assist with preparation of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)
  • Support project management activities including taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study-status trackers.
  • Assist with preparation and distribution of investigator site contracts and budgets
  • Maintain the Trial Master File all clinical projects



Qualifications



SKILLS & REQUIREMENTS:



  • Bachelor’s Degree in health sciences related field, RN, or related discipline required
  • Minimum 3-5 years relevant experience
  • Excellent written and verbal communication skills
  • Strong PC skills (MS Word, MS Excel, MS Project)
  • Sound analytical and problem-solving skills
  • Act with consistent sense of urgency with acute attention to detail
  • Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred.
  • Experience with Veeva preferred
  • Exceptional organizational and time management skills

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