CRA II/Senior CRA, Early Phase
- Experience Level
- Experienced (non-manager)
Across the globe, we keep our commitment to improve health and improve lives and at Covance by Labcorp we are looking for exceptional people who are eager to play an important role pushing new frontiers in how we diagnose, monitor and treat patients.
Our Drug Development business continues to support and meet the needs of our pharmaceutical and biotechnology client partners: we continue to initiate new studies from Early Development through Phase IV, and our Central Labs are fully operational.
As a CRA II, you will be monitoring cutting edge, novel, newly evolving and numerous types of Phase 1 studies and avariety of Protocols/study designs. Typically monitoring, from study start to finish, smaller subject populations.
WHY Covance by Labcorp?
At Covance by Labcorp you'll experience:
* Career progression & learning: Covance by Labcorp works with a wide number of clients, you'll have the possibility to learn different ways of working and developing in your role.
* Where do you see yourself moving forward long-term? Do you want to become an expert in a specific Therapeutic Area? Or to diversify your scientificknowledge? Or gain expertise in a specific study phase (from I - IV)? We will support you to accommodate your career expectations.
* Unlike other CROs, there are not fixed boundaries between teams: we offer flexibility with great opportunity to grow into a variety of areas such as Project Management, Clinical Team Leadership, Line Management and cross border roles.
*We are a small Phase I Monitoring Services department within a large organization.
Your main responsibilities will include but not be restricted to:
- Responsible for all aspects of Phase 1 study site monitoring including process monitoring, routine monitoring and close-out at the Leeds Clinical Research Unit and occasionally external clinical sites; maintenance of study files, conduct of initiation visits (limited pre-study visits).
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter healthy volunteers into the study.
- Ensure the protection of study volunteers by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausibledata.
- Travel to Leeds CRU and external Phase I units and/or hospital sites will be required and is an essential function of the job. Majority of monitoring is at the same site/Leeds CRU. Air travel may be required.
- Prepare accurate and timely trip reports.
- Independently perform 100% source data review and verification/eCRF review, query generation and resolution against established data review guidelines on Covance by Labcorp or client data management systems, as assigned by management.
- Monitoring in alignment with Cohort recruitment to agreed deadlines.
- Update, track and maintain study specific trial management tools/systems.
- Track and follow-up on site issues.
- Implement and maintain study specific monitoring plans.
- Prepare and present training content for Site Initiation Visits.
- Pharmacy monitoring including IMP and document accountability, stability and storageconditions of clinical trials materialsas required by Sponsor, investigational product inventory.
- Assist with training of new employees, e.g. co-monitoring.
Covance by Labcorp Clinical Pharmacology Services: today's 50 top-selling FDA approved drugs were supported by Covance by Labcorp. By working in-house on Covance by Labcorp studies, you will be immersed in tools and processes that have allowed us to successfully conduct over 720 oncology trials since 2012 in over 75 countries.
Full and clean UK driving licence.
- University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing license)AND
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
- Thorough knowledge of monitoring procedures.
- Basic understanding of the clinical trial process.
- A minimum of 2 years of clinical monitoring experience.
- A minimum of 2 years of Clinical Monitoring experience.
- Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
- Good planning, organization and problem solving abilities
- Good communication and interpersonal skills
- Good analytical and negotiation skills
- Computer competency
- Fluent in local office language and in English, both written and verbal
- Works efficientlyand effectively in a matrix environment
- Oneor more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
Join us and see why Covance by Labcorp has been named by Forbes as one of the World's Best Employers 2020 and more than 90% of the top 20 global pharmaceutical companies are repeat customers. We can offer you not only a job, but a stable, long-term international career.