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In-House CRA Manager

Norwood, MA

Posted: 10/31/2018 Job Category: Clinical: Clinical Operations and Development Job Number: 2199

The In-House CRA Manager (Clinical Trial Associate Manager) is a line management position and may be integrated into a study team based on program needs. Based on experience, the CTAM 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 CTAM 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 CTAM is responsible for providing guidance, mentorship, and training for more junior team members. The CTAM will conduct regular performance reviews with direct reports and will make recommendations regarding resourcing and career progression to Management.

PRIMARY RESPONSIBILITIES:
  • Ensure compliance with protocol and overall objectives across all investigator sites and studies
  • Ensures 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 are developed and maintained
  • Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes
  • Ensures execution of study activities according to study protocol, regulatory guidelines and operational plan
  • Reviews Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures
  • Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards
  • Participates in the planning and execution of study start-up, conduct and closeout activities
  • Assist preparation of vendor requests for proposals and track receipt of proposals, MSAs and SOWs
  • Provides oversight for the collection and review of site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.)
  • Provides oversight for the assembly and distribution of regulatory binders to clinical sites
  • Provides oversight for the development of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)
  • Provides oversight for project management activities ensuring consistency and completion of tasks such as 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
  • Provides oversight for the maintenance of the Trial Master File for all clinical projects

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
  • Exceptional organizational and time management skills

Kelley Ross
Clinical Recruiter

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