Parexel

Parexel

Senior Clinical Research Associate - Oncology - Midwest or Southwest US - FSP

United States - Remote · Senior

Sponsorship not specifiedDetected 13 days ago
GCPNegotiationClinical TrialsClinical ResearchGMPResearchCommunicationCollaborationProblem Solving

About the role

  • The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s).
  • The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner.
  • The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.

Responsibilities

  • Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the
  • Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles.
  • Initiates, monitors and closes study sites in compliance with client's Procedural Documents.
  • Drives performance at the sites.
  • Manages study supplies (ISF, etc), drug supplies and drug accountability at study site.
  • Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
  • Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
  • Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and CQAD.
  • Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, client's SOPs and local requirements.
  • Supports/participates in regular QC checks performed by LSAD or delegate.

Requirements

  • 5+ years of on site monitoring experience in a CRO or pharma organization
  • 1+ years of oncology monitoring experience
  • Bachelor degree in related discipline, preferably in life science, or equivalent qualification
  • Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
  • Good knowledge of relevant local regulations.
  • Ability to travel nationally/internationally as required.
  • In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance.
  • Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study.
  • Updates CTMS and other systems with data from study sites as per required timelines.
  • If required, determines and discusses with LSAD the correct timing and type of visits.

Skills

  • Ability to work in an environment of remote collaborators.
  • Good analytical and problem-solving skills.
  • Familiar with risk-based monitoring approach including remote monitoring.
  • Good cultural awareness.
  • EEO Disclaimer
  • Parexel is an equal opportunity employer.

Benefits

  • At Parexel, we all share the same goal - to improve the world's health.
  • Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient.

Company info

  • When our values align, there's no limit to what we can achieve.
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