Clinical Research Associate – 12 Month Contract

Research AnalystResearch AnalystContractRemoteMid LevelTeam 10,001+Since 1999H1B SponsorCompany SiteLinkedIn

Location

Canada

Posted

4 days ago

Salary

$109.1K - $143.3K / year

Seniority

Mid Level

Bachelor DegreeExperience acceptedEnglishGoogle Cloud Platform

Job Description

Clinical Research Associate – 12 Month Contract

AstraZeneca

• Contributes to the selection of potential investigators • In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance • Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study • Trains, supports and advises Investigators and site staff in study-related matters, including Risk Based Quality Management (RbQM) principles • 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 • Ensures the sites are inspection ready at all times • Actively participates in Local Study Team (LST) meetings • Contributes to National Investigators meetings, as applicable • Initiates, monitors and closes study sites in compliance with AZ Procedural Documents • Shares information on patient recruitment and study site progress (site quality/performance) within the LST • Drives performance at the sites • Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate • Updates CTMS and other systems with data from study sites as per required timelines • Manages study supplies (ISF, etc), drug supplies and drug accountability at study site • Prepares study drug for destruction, if applicable • Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study-specific Monitoring Plan • If required, determines and discusses with LSAD the correct timing and type of visits • 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 • Ensures data query resolution in a timely manner • Works with data management to ensure robust quality of the collected study data • Ensures accurate and timely reporting of Serious Adverse Events and their follow-ups • Prepares and finalises monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP • Follows up on outstanding actions with study sites to ensure resolution in a timely manner • Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required • Assists site in maintaining inspection-ready ISF • Prepares for and collaborates with 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 ICH-GCP, AZ SOPs and local requirements • Supports/participates in regular QC checks performed by LSAD or delegate • Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF • Provides feedback on any research-related information including sites/investigators/competing studies that might be useful for the local market • Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment) • Ensures compliance with local, national and regional legislation, as applicable • Collaborates with local MSLs as directed by LSAD or line manager

Job Requirements

  • 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
  • Good medical knowledge and ability to learn relevant AZ Therapeutic Areas
  • Basic understanding of the drug development process
  • Good understanding of Clinical Study Management including monitoring, study drug handling and data management
  • Excellent attention to details
  • Good written and verbal communication skills
  • Good collaboration and interpersonal skills
  • Good negotiation skills
  • Ability to travel nationally/internationally as required
  • Valid G driving license

Benefits

  • competitive Flex Benefits & Retirement Savings Program
  • 4 weeks’ paid vacation
  • annual Personal Days

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