Senior CRA

Hobson Prior are currently in search for a Senior CRA to join a Global CRO who help people improve and accelerate the delivery of therapies that can impact health worldwide. This is a permanent position based in Copenhagen, Denmark.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• Accountable to perform site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
• Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
  - Assesses site processes
  - Conducts Source Document Review of appropriate site source documents and medical records
  - Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
  - Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
  -Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
  -Verifies site compliance with electronic data capture requirement
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
• Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
• Supports subject/patient recruitment, retention and awareness strategies.
• Any other assigned duties.

Key Skills:

• Excellent communication, presentation, and interpersonal skills.
• Requires good computer skills with the ability to embrace new technologies.
• Basic level of critical thinking skills.

Requirements:

• Requires a bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Ability to manage required travel of up to 75% on a regular basis.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.