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Clinical Research Associate Manager

Norwood, MA

Posted: 03/24/2019 Job Category: Clinical: Clinical Operations and Development Job Number: 2001

The Clinical Research Associate Manager (CRAM) is a seasoned professional with wide-ranging experience and a thorough understanding of GCP and ICH principles. The CRAM proactively identifies and resolves complex issues where an analysis of situations and data requires an in-depth evaluation of multiple factors. Exercising sound judgement in selecting methods and techniques and evaluating criteria for resolving issues, the CRAM will establish strong, positive relationships with both internal and external partners. The successful candidate contributes to the determination or development of methods and procedures at the project and company levels.

The CRAM must be self-motivated, independent and able to work in a small team environment. The successful candidate will be a highly organized individual who can also multitask and adjust direction based on changing project/corporate priorities. The CRAM will provide leadership and career development, mentoring and training for CRA staff. The CRAM will conduct regular performance reviews with direct reports and will make recommendations regarding resourcing and career progression to Management.

Primary Responsibilities:
  • Provides support to clinical program managers in resourcing CRAs for planned and ongoing clinical trials
  • Supervises and assists with CRA study team assignments and work load
  • Monitors performance of CRAs on a continuous basis including review of monitoring visit reports, ensuring appropriate and timely investigator site visit schedules
  • Conducts CRA monitoring performance assessments (e.g., co-monitoring) and/or other training as warranted
  • May be assigned to study team or other projects based on program/company needs including:
    • Perform investigator site pre-study site qualification visits including collection of site regulatory documents
    • Assist with site start-up activities including site contracts and budget development/negotiation, and preparation of IRB submissions (including follow through to ensure successful outcome)
    • Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team (i.e., central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites
  • Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug
  • Participate in/lead the Investigator/Initiation Meetings, ensuring the study staff conducting the study have received the proper materials, instructions and training to safely and accurately conduct the study in line with protocol requirements
  • Assist in the development of study/program plans (i.e., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.)
  • Track the movement of laboratory samples and the resulting data, including the trans-shipment of samples to specialty laboratories, or movement of samples to sample-management storage
  • Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e., study-site webinars, newsletters or other potential creative solutions)
  • Monitor recruitment, data quality and patient safety while on site and remotely through EDC systems and direct site communication
  • Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries
  • Maintain project files including ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical-trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, all investigator and site correspondence, and schedules of payment
  • Identify and complete follow-up of SAEs at study sites
  • Assist with data listing, data coding, patient profile reviews, database lock, and site close-out activities
  • Ensure appropriate and timely submission of documents to the Trial Master File

Skills & Requirements:
  • Bachelor’ s Degree in health sciences related field, RN or related discipline required
  • Minimum 4 years' field-based monitoring or other relevant experience
  • Prior line management experience is a plus
  • Thorough knowledge of ICH GCP guidelines
  • Strong written and verbal communication ability
  • Strong PC skills (MS Word, MS Excel, MS Project)
  • Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred
  • Experience with Outsourced Clinical Trials required
  • Ability to travel 25-50% required
  • Ability to mentor and train other CRAs

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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