Clinical Research Associate (CRA), Norway

Clinical Research Associate (CRA), Norway
TFS, Norway

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
As mentioned in job details
Total Vacancies
1 Job
Posted on
Aug 21, 2021
Last Date
Sep 21, 2021
Location(s)

Job Description


Responsibilities

  • Obtain and maintain essential documentation in compliance with ICH-GCP, AZ procedural documents and local regulations both in trial master file (TMF) and investigator study file (ISF).
  • Actively participate in local study team meetings.
  • Contribute to the selection of potential investigators.
  • Train, support and advise investigators and site staff in study related matters.
  • Contribute to national investigators meetings.
  • Initiate, monitor and close study sites in compliance with AZ procedural documents. Share information on patient recruitment and study site progress within local study team.
  • Drive performance at the sites. Proactively identify study-related issues, solutions and escalate as appropriate.
  • Update CTMS and other systems with data from centers as per required timelines.
  • Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
  • Perform source data verification according to SDV plan.
  • Oversee data query resolution by the site.
  • Verify accurate and timely reporting of serious adverse events.
  • Prepare for activities associated with audits and regulatory inspections in liaison with local study delivery team lead and CQM.
  • Provide the required monitoring visit reports within required timelines.
  • Work with data management to confirm quality of the study data.
  • Support and work together with lead CRA, LSM and regulatory affairs to see to timely delivery of study documents for submissions to RA and EC.
  • Contribute to financial agreements with relevant staff at investigational site in collaboration with lead CRA and/or LSM.
  • Oversee timely preparation of country specific CSA in collaboration with LSM and/or lead CRA.
  • Verify compliance with AZ’s code of conduct and company policies and procedures relating to people, finance, technology, security and safety, health and environment.
  • Track and manage agreed payments at study site level.
  • Participate in training and mentoring of new members of the local study team verifying compliance with ICH/GCP and AZ procedural documents.
  • Confirm that all study documents are ready for final archiving and sign-off completion of local part of the trial master file.
  • Contribute to process improvements, knowledge transfer and best practice sharing.
  • Actively share applicable information that may be relevant to marketing and sales and the MC medical department and in accordance with corporate ethical guidelines.

Benefits

- Car Allowance

- Flexible Working Hours

- Corporate pension plan

- Life insurance

- Health care insurance

Job Specification

Job Rewards and Benefits

TFS

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