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Clinical Research Associate II/III

Norwood, MA

Posted: 03/18/2019 Job Category: Clinical: Clinical Operations and Development Job Number: 2194

The Clinical Research Associate  II is a self-motivated individual able to work in a small-team environment and to independently identify tasks/issues of critical importance. In this role, you will develop a thorough knowledge of GCP, ICH and CFR principles. The successful candidate will be a highly-organized individual who can multitask and adjust direction based on changing project/corporate priorities.

As the primary point of contact for investigator sites, the CRA II ensures the clinical trial is conducted according to appropriate guidelines and protocols. You will be responsible for the efficient execution of monitoring and other clinical trial management activities while tracking the progress of assigned studies and project. Proactively identifying potential challenges, the CRA II develops appropriate actions to resolve issues and achieve target objectives.

PRIMARY RESPONSIBILITIES:
  • 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 successful outcomes)
  • 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 Investigator/Initiation Meetings and ensure that 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 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 and patient profile reviews, database lock, and site close-out activities
  • Ensure appropriate and timely submission of documents to the Trial Master File

REQUIREMENTS:
  • Bachelor’ s Degree in health sciences related field, RN or related discipline required
  • Minimum 3 years field-based monitoring or other relevant experience
  • 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.
    Clinical Research Associate III (CRA III)

    Job Description

    The CRA III is an experienced professional with a comprehensive understanding of CRA responsibilities, GCP and ICH principles.  The CRA III may act as a CRA team leader for an assigned study/program, and in doing so will demonstrate an ability to handle a diverse range of issues where situational awareness and data analysis is required.  With sound judgement in identifying issues and selecting methods and approaches to resolving said issues, the CRA III will effectively establish a stable network with internal and external personnel.  The successful candidate is self-motivated, highly-organized, can multi-task and able to work in a small-team environment.

    As the primary point of contact for investigator sites, the CRA III is responsible for ensuring the clinical trial is conducted according to CFR, ICH and GCP guidelines. The successful candidate is efficient at executing monitoring and other clinical trial management activities while tracking the progress of assigned studies/projects and identifying and resolving challenges to achieve target objectives.

     

    PRIMARY RESPONSIBILITIES:
  • 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 3-6 years field-based monitoring or other relevant experience.
  • Thorough knowledge of ICHGCP 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

 

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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