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Lead Medical Research Associate

Employment Type Contract
Field of Work Clinical/Medical

 

The lead Medical Research Associate (Lead MRA) will be responsible for supporting the Clinical Monitor Local (CML) in leading the trial teams and be responsible for end-to-end Site Management activities. This includes but is not limited to:

  • Assistance in leading the trial team
  • Operationalize the strategic direction given by the CML during planning, conduct and closure of assigned trials
  • Maintain quality oversight for assigned trial
  • Enters country level information in Company CTMS and other related systems
  • Perform user acceptance testing
  • Facilitate local trial team meetings
  • Update trial budget, systems, project plans and tracker
  • Serves as single point of contact for all MRAs assigned to the trial including the coordination and harmonization of activities, answering trial related questions, etc.
  • Provide reports to CML on OPU contribution status, local issues, budget etc.
  • Partner with the CML in the development of a local trial implementation strategy (incl. site engagement/selection/start-up strategy)
  • Work with local colleagues to ensure start-up is achieved according to local timelines/goals
  • Support the CML in study sites review and selection
  • Support CML in the preparation and conduct (may include delivery of presentations and trainings) in (local/regional) Investigator Meetings if required
  • Maintain oversight of key trial deliverables, take appropriate action and make recommendations to the CML (e.g. site initiation, patient recruitment, data cleaning, DBL)
  • Follow up on audit/inspection findings and actively support implementation of CAPA
  • Maintain accurate local budget and collaborate with controlling to be aligned with binding trial budgets
  • In collaboration with LDS/GDS ensure quality of country level TMF
  • Supports the CML in ensuring quality oversight and data integrity of the trial at the country level
  • Support site & sponsor inspection readiness preparation, represent the trial (OPU level) during inspections if appropriate
  • In close partnership with R&R group, TCM and CML, implement recruitment and retention strategies
  • Maintain vendor oversight (e.g. lab, ancillary supplies, pharmacy cards)
  • Oversee close out activities (collection of essential documents, etc.)

Site Management Activities:

  • Serve as first line of contact for site staff in trial related questions pertaining to planning, conduct and closure of assigned clinical trials and sites
  • Maintain oversight of all site start-up and conduct-related activities (e.g. contracts, Essential Documents (e.g. RegDocs), training, Informed Consent Form updates, IMP re-supply)
  • Responsible for site logistics including review, distribution and tracking of site related documents & materials (e.g. ICFs, protocols, supplies)
  • Update and maintain trial-specific system/databases/tracker
  • Responsible for project compliance according to project plans and related tools
  • In close partnership with other stakeholders (e.g. Manager, Site Monitoring) maintain quality and operational oversight for assigned sites and escalate issues to the CML, as appropriate.
  • In close partnership with other stakeholders (e.g. CRAs) take appropriate actions and make recommendations to the CML for improving site performance and/or quality
  • Identify risks and propose and implement mitigation strategies
  • Perform monitoring trip report review & sign-off. Communicate significant issues to the CML
  • Serve as CAPA lead
  • Develop trial specific documents (e.g. newsletters). Submit for review and approval to CML
  • Closely track site recruitment and patient retention
  • Maintain oversight of data quality and integrity through review of systems and trackers
  • In collaboration with Local Document Specialist (LDS)/Global Document Specialist (GDS) ensure quality of TMF for assigned sites
  • Review and reconcile invoices/payments with internal partner(s), as appropriate
  • Actively participate in trial team meetings including the creation and distribution of meeting minutes
  • Create trial specific slide decks, training material, etc. in accordance with Company requirements
  • May support Customer Relations Group in answering and appropriately routing site calls
  • Participate in (local/regional) Investigator Meetings, as requested
  • Support site & sponsor inspection readiness activities
  • Provide support to US-based Trial Clinical Monitors (TCM) who lead global trial teams during planning, conduct and reporting clinical trials
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