Specialized Recruiting. Temporary Staffing. Managed Services. 800 876 2314


Regional CRA

Employment Type Permanent
Field of Work Clinical/Medical

 

Position Summary

Responsible for performing study activities regarding the implementation, monitoring and summarization of clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and Standard Operating Procedure (SOPs). Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within Clinical Medical Regulatory (CMR).

 

Primary Responsibilities

  • Ensures compliance with the application and communication of all Company policies, procedures and fundamentals.
  • May participate in continuous improvement processes for function.
  • Acts as primary liaison for assigned study sites while on-site to convey project information, answer questions and resolve site-related issues in accordance with the CTM escalation pathway to the Lead Clinical Research Associate (CRA).
  • Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of site related performance and documentation.
  • Prepares, collaborates and implements Corrective Action Plans (CAP) with investigative sites with oversight from Lead CRA.
  • Assures adequate and appropriate dissemination of information between project team members to ensure project success in accordance with the CTM Communication Pathway or Project Specific Communication Plan.
  • Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and Company SOPs.
  • Attends Investigator Meetings and study-specific training for assigned trials.
  • Attends site audits according to the CTM Audit Management Plan and executes audit action plans with support from Lead CRA/PM as appropriate.
  • Collaborates with the Lead CRA(s) to obtain/share trial-specific issues across all study sites concentrating on areas related to quality, site performance and metrics.
  • Responsible for communicating issues in accordance with the CTM escalation pathway to the Lead CRA(s) as appropriate.
  • Completes Site Selection, Site Initiation, Routine Monitoring and Closeout Visits according to SOPs, and completes reports and follow-up letters to quality standards within company specified timelines.
  • Develops and maintains collaborative working relationships with clinical investigative sites.
  • Accountable for data integrity, patient safety and regulatory compliance for all assigned sites.
  • Knowledgeable of assigned protocol(s) and trial-specific manuals/plans to ensure quality and deliverables are met across assigned sites.
  • Maintains current Investigator Trial Files (ITF) in accordance with Company SOPs.
  • Performs ongoing reviews of ITF to assure quality of the documentation and compliance with Company SOPs, GCP and ICH Guidelines while on site.
  • Monitors recruitment and data quality while on site and remotely through EDC systems and communication with sites.
  • Performs on-site drug accountability, reconciliation and return.
  • Verifies trial product storage meets protocol and SOP requirements.
  • May provide guidance, mentoring and training to less experienced CTM staff to build talent across the department. May support the maintenance of guidelines, training programs, policies and procedures.
  • Active participation on local project teams. Ensures the mandatory trial entries are made in the applicable systems. Maintains focus for specific project activities within CMR priorities.
  • Participates in cross-functional teams, locally, to assure timely attainment of project milestones. Responsible for the compliance and quality of CATS reporting for self.
  • Attends relevant symposia, conferences and scientific meetings, as necessary. May provide support of training needs across CTM and may support the creation, development and potentially provide training support to meet those needs. This includes sharing of lessons learned across the project team members and/or CTM.

Qualifications

  • A minimum of 2 years of on-site monitoring experience (with Bachelor’s degree) or 3 years of on-site monitoring experience (with RN)
  • A minimum of 4 years of clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting; some experience in area of specialty preferred
  • A Registered Nurse (RN) or Bachelor’s degree required (in science-related discipline preferred)
  • Demonstrated computer skills (MS Office, MS Project, MS PowerPoint)
  • Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan
  • Knowledge of GCP as relates to clinical trial management

Physical Requirements

  • 50-75% overnight travel required. Must live within 50 miles of the regional workload center within assigned region
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