CRA I, Early Phase
- Experience Level
- Experienced (non-manager)
Covance by Labcorp is still actively hiring throughout the COVID-19 outbreak.
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.
Full time and permanent office-based opportunity in Leeds, West Yorkshire, United Kingdom.
Are you an ambitious CRA?
* 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.
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? Do you want to become an expert in a specific Therapeutic Area? Or to diversify your scientificknowledge? Or gaining 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 department within a large organisation.
Your main responsibilities will include but not be restricted to:
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites maintenanceof study files, conduct of pre-study and initiationvisits, liaise with vendors and other duties assigned.
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter 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.
- Ensure studydata completeness, accuracy, consistency and compliance; identifies deficiencies, deviations and discrepancies and provide training and/or initiate corrective action as required.
- 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 reviewguidelines, with or without direct supervision, on Covance by Labcorp or client data management systems, as assignedby management.
- Monitoring in alignment with Cohort recruitmentto agreed deadlines.
- Update, track and maintain study-specific monitoringplans.
- Prepare and present training content for Site Initiation Visits.
- Pharmacy monitoring including IMP and documentaccountability, stability and storage conditions of clinical trials as required by Sponsor, investigational product inventory.
- No days-on-site metric adherence.
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 a minimum of 2 years of experience in a related role (e.g. site management, in house CRA, study coordinator, research nurse, etc.).
- A minimum of two years' experience in a related role (site management, in-house CRA, study coordinator etc.)
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing license) AND a minimum of 2 years of experience in a related role (e.g. site management, in house CRA, study coordinator, research nurse, etc.).
- Minimum of 6 months of experience as an In-House CRA OR a minimum of 2 years clinical trials or site management experience (e.g. study coordinator, project coordinator, project specialist, study start-up).
- Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirement
- Basic understanding of the clinical trial process
- Working knowledge of Covance by Labcorp SOPs for site monitoring is preferred
- Ability to monito r study sites according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Ability to work within a project team
- Good plannin g, organization and problem solving abilities
- Good communication skills, oral and written
- Good computer skills
- Works efficientlyand effectively in a matrix environment
- Fluent in local office language and in English, both written and verbal
- One or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data anal y sis, data management or technical writing) is preferred.
Join us and see why by Labcorp have 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.