CRA I or CRA II (all genders)
- Experience Level
The CRA will be assigned clinical monitoring activities in a single country or in several countries ensuring quality service and appropriate clinical study conduct.
The CRA shall guarantee the adequacy, the reliability and quality of the data collected from sites and shall participate in the quality control processes.
The 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 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, CRF Completion Guideline, Patient Information and Informed Consent Form and validation tools etc.
- Assists in the submission to the Independent Ethics Committees (central and local) and to Competent / Regulatory Authorities
- Assists in developing of Investigator and Institution contracts, negotiates budgets 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, perform 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
- Manages his/her own visit schedule, appointments and the follow-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 CRA informs the PM (directly or via the Lead CRA) of any issues with the centre and the PM/ Lead CRA is responsible for the close communication with the Sponsor. If Linical provides only monitoring services the 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.
- Participates in relevant job/study related trainings
- Participates in investigator meetings
- Performs activities in other clinical research areas according to the directive of superior
At Linical, we embrace the opportunities and possibilities that are held by diversity, equal opportunity and inclusion. We value bringing together individuals from diverse backgrounds regardless of race, disability, ethnicity, gender, sexual orientation or any other legally protected characteristic. Linical will consider all candidates that match with the requirements of the position, promoting diversity and equal opportunity for all.