PRAHS

2017-41608

- | US-PA-Blue Bell
3 months ago
Title
Site Management Associate - Late Phase Services

Overview

The Site Management Associate performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, in-house site management, and data review activities in accordance with the study protocol, client and/or PRA standard operating procedures (SOPs), and all applicable guidelines and regulatory requirements (e.g. ICH-GCP, and country/region specific).
The Lead Site Management Associate (Level 3 - Advanced) will directly oversee the management of study sites for assigned studies, and coordinate and provide oversight for all activities of the Site Management Associates to ensure all tasks meet client and PPA expectations, are delivered in compliance with the late phase study design. Works with the OTL to provide oversight for the study team. For studies which require minimal or no on-site monitoring, the Lead SMA may act as the primary lead for the clinical study team. The Lead SMA contributes to Business Development activities by participating in proposals and bid defenses, as required.

Responsibilities

  • Recruits and evaluates potential sites for participation in LPS studies
    • Utilizes assessment tools, questionnaires, and study site materials in evaluation of study sites
  • Performs Essential Document Collection, Review, Maintenance and Close Out activities
    • Ensures sponsor and investigator obligations are met in compliance with applicable guidelines and local regulatory requirements
    • Supports investigators with submissions according to applicable local, regulatory, and IRB/IEC requirements
  • Performs Study Tracking to ensure that the study files are current, accurate, and complete
    • Tracks clinical study management information in CTMS
    • Documents site and client contact and study interactions in a timely and professional manner
  • Liaises With Internal and External Customers to meet project specific goals
    • Participates in sponsor and project-related meetings and appropriately interacts with client and team
    • Acts as a liaison with clinical supply/service vendors and other functional area team members to meet project team goals 
  • Manages study sites to ensure adherence to the late phase study design
    • Acts as primary point of contact for assigned study sites
    • Tracks patient enrollment, study supplies, and data entry efforts for assigned study sites
    • Escalates unresolved issues to the appropriate project team member(s)
    • Will have study coordinating center responsibility on a rotational basis as assigned by Manager, or designee
  • Performs data review and query resolution tasks for assigned sites
    • Reviews the clinical data for enrolled patients and data discrepancies within clinical databases
    • Creates queries related to the CRF/eCRF data (DCF - Data Clarification Forms)
    • Communicates with study sites to achieve resolution to outstanding data queries 
  • Follows database closure procedures for freezing, locking, and unlocking clinical databases 
  • Resolves internal and external clinical issues for client research projects
    • Assists in maintaining clinical project documents, including Site and/or Data Management Plans, Monitoring Guidelines, Data Review Guidelines, Site Operations Manuals and Monitoring Visit Letter Templates under guidance of Operational Team Lead/Lead SMA
    • Interacts with client(s), vendors and PRA functional areas as secondary project contact for clinical issues
    • Provides clinical status information to team members and project management under guidance of Operational Team Lead/Lead SMA 
  • Implements and monitors post-marketing studies to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines
  • Coordinates and conducts telephone PSSV, SIV, and COV visits in order to assess the qualification of potential study sites, to initiate and instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected, and to terminate studies
    • Provides regular clinical status information to team members and project management
    • Ensures Serious Adverse Event (SAE) reporting according to project specifications
  • May create assessment tools, questionnaires, and study site materials to be used in evaluation of study sites
  • Supports Operational Team Lead/Lead SMA in management of clinical budget and evaluation of study processes
    • Manages time and project requirements based on study contract; identifies and documents out of scope activities
    • Evaluates metric data to identify process improvements
  • Coordinates and provides oversight for specific activities to ensure client and PRA expectations are met in compliance with late phase study design
  • Perform submissions and notifications to Regulatory Authorities, IECs and other bodies according to applicable guidelines, regulatory requirements and SOPs
  • Conducts patient interviews, when applicable, for assigned studies.
  • Utilizes relevant tools/instruments (e.g. QoL questionnaires, surveys, etc.) during interview process to obtain study required information.
  • Addresses patient questions utilizing acquired knowledge of the areas under study, specialized training received as part of the assigned study(ies), applicable frequently asked questions lists (FAQs), and via sponsor/PRA/study approved references.
  • Escalates questions to appropriate personnel as defined by the study(ies) as necessary while ensuring patient confidentiality is maintained.
  • Identifies potential unreported Adverse Events and Serious Adverse Events during patient interview and appropriately processes according to study protocol guidelines and Sponsor/PRA SOPs.

Qualifications

 

  • Read, write, and speak fluent English; fluent in host country language required.
  • Prior experience using computerized information systems required. 
  • Minimum of one year Clinical trials support, Data Coordination or pharmaceutical industry experience required.
  • Office-based or clinical experience required



  • Undergraduate degree or its international equivalent from an accredited institution is required.



  • A degree in a clinical, science, or health-related field is preferred.
  • Prior customer service experience preferred
  • Proficiency in additional languages preferred
  • Prior experience using computerized information systems required; experience with Electronic Data Capture, PC Windows, word processing, and electronic spreadsheets preferred
  • Knowledge of ICH and local regulatory authority drug research and development regulations preferred.





PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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