Linical Co., Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With approximately 900 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.
Linical’s European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-established affiliate operations in key emerging markets in Central- and Eastern Europe.
We offer individualized solutions that are tailored to the specific needs of our sponsors. We work as integrated teams functioning with maximum transparency throughout each study, making sure that the sponsor is kept up to date on all study parameters and progress. We are dedicated to the highest standards of quality, with a special focus on the therapeutic areas oncology, immunology and CNS, based on experience and expertise
SCRA Job Scope:
The Senior CRA will be assigned clinical monitoring activities in a single country or in several countries ensuring quality service and appropriate clinical study conduct. The Senior CRA shall guarantee the adequacy, the reliability and quality of the data collected from sites and shall participate in the quality control processes. The Senior CRA will make sure that the conduct of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with any applicable regulatory requirements in the assigned countries.
The Senior CRA will have to anticipate, recognize and resolve issues in the served study sites.
Description of the tasks / routine work:
- Review and/or input to study protocol, CRF and validation tools
- Preparation and/or review of any kind of study documents, Monitoring Guidelines, CRF Completion Guidelines, Patient Information and Informed Consent Form etc.
- Prepare the submission to the Independent Ethics Committees (central and local) and when applicable to Competent/Regulatory Authorities
- Assists in developing of Investigator and Institution contracts and budget template, negotiates budgets with sites and arranges site payments
Participates to Investigators selection/feasibility: e.g. phone contacts, questionnaire in the appropriate country
- Conduct of site qualification visits (pre-study visits)
- Conduct of site initiation- and site close out visits
- Conduct of regular monitoring visits: check of accuracy of study procedures, source data/document verification to ensure protocol compliance and that the clinical data are complete, logical and accurate, check consistency within CRFs, perform translation, collection of CRFs, follow-up of SAE, visit the pharmacy or designated Investigator facility (if applicable) to ensure that the IP has been adequately delivered, checks that there is an adequate stock, performs IP accountability control, checks that the storage conditions are eligible, that the storage temperature control is adequately documented and ensures the IP destruction or return
- Ensures that the site is equipped with all necessary supplies for timely reporting and that the procedures (sampling storage and shipment logistics) are appropriately adhered to
- Writes a site visit report after each type of visit, in which the tasks performed during the visit and any problems encountered are reported, along with follow-up on any outstanding issues. This report must be completed with the appropriate logs (CRF transmission form, drug accountability log, samples log etc.) according to the study and the Sponsor’s requests
- Writes a corresponding site visit follow-up letter for the purpose of on-site quality optimization
- Distributes any documents collected during the monitoring visit to the appropriate department (data entry, assistants for archiving etc.)
- Responsible for the quality of data from his/her own sites
- Resolves questions/issues with investigator/trial staff including query verification
- Resolves and writes Data Clarification Forms, and reviews datalistings
- Manages his/her own visit schedule, appointments and the following-up of issues between visits under, along with regular communication with the sites and the clinical study team
- Maintain close contact with the investigators on-site, the centre study coordinator the pharmacist and other involved parties to be aware of any possible patient enrolments, the enrolled patients’ status, the IP stock and any further site requests or problems. The Senior CRA informs the PM (directly or via the Lead CRA) of any issues with the centre and the PM/Lead CRA is responsible for close communication with the Sponsor. If Linical provides only monitoring services the Senior CRA reports directly to the sponsor’s responsible person
- Filing and update of study documentation in the Investigator Site File and Pharmacy File (if applicable) and the TMF or Project File within the Linical office throughout the study.
- Review of Trial Master File (TMF) and ensure that all documents are in order, logical, accurate, complete, up-to-date and ready for a study audit and/or inspection
- Participates in relevant job/study related trainings
- Participates in investigators meetings and assists in the preparation of these meetings
- Performs activities in other clinical research areas according to the directive of superior
- Provide project specific training/mentoring to new team members
- Perform co-monitoring training with new CRAs
University degree (e.g. Master), scientific background (e.g. Pharmacy, Pharmacology, Biology, Chemistry, Medicine, Veterinary Medicine) or education as medical documentalist, nurse, medical/ pharmaceutical/ biological technical assistant, doctor’s assistant, or other profession if experience beyond four years within clinical research (at a Clinical Operations Division in a CRO or Pharmaceutical company) or equivalent education is demonstrated and a minimum of 4 (+) years of experience as CRA in a CRO or Pharmaceutical company
Familiar with the principles of ICH GCP, SOPs and any applicable regulatory requirements and legislation governing the conduct of clinical trials in those countries in which the study is conducted and the CRA is responsible for.
Familiar with MS Office tools
Very high level of English language in speaking and writing