Experienced Clinical Research Associate
Reading, イギリス
Job Description
Responsibilities
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Collaborate and liaise with study team members for project execution support as appropriate
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis
Requirements
- Experience of independent on-site monitoring in the UK
- Life science degree educated or equivalent industry experience
- Flexibility to travel to sites as required
#LI-ADAMTHOMPSON
*Please note - this role is not eligible for UK visa sponsorship*
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
類似職種
-
R1435466
Sr. CRA 1
複数勤務地詳細はこちら
-
R1417984
Experienced Clinical Research Associate, Sponsor Dedicated
複数勤務地詳細はこちら
Join our Global Talent Network
最近情報を配信しています。新しい希望に合った求人がオープンした際にご案内させていただきますので、ご登録ください。