Due to continued growth, we are looking for a Clinical Research Associate (Level II or Senior) to work for a global and prestigious pharmaceutical company.
This is a full time permanent role. Office-based in Kiev.
Previous experience in on-site monitoring is required or work experience as a sub-investigator.
Experience in on-site monitoring of oncology clinical trials would be an adtvantage
Previous experience as a Clinical Research Associate (CRA)
Willingness to travel with occasional overnight stay away from home.
Good written and oral communication skills.
Be able to work office-based in Kiev
Summary of the job
CRA serves as primary contact point between the sponsor and the investigational site. A CRA is assigned to clinical trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock.
Responsibilities include site selection, pre trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out. Partnera with the CTA/IDA, LTM and GTM to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement, training and mentoring of other CRAs.
Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
Acts as primary local company contact for assigned sites for specific trials.
Attends/participates in investigator meetings as needed.
Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
Contributes to site level recruitment strategy
Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
Ensures site staff complete the data entry and resolve queries within expected timelines.
Ensures accuracy, validity and completeness of data collected at trial sites
Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate.
Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints.
Fully documents trial related activities in particular monitoring. Writes visit reports and uploads into eTMF
Collaborates with Local Trial Managers for documenting and communicating site/study progress and issues to trial central team.
Prepares trial sites for close out, conduct final close out visit.
Negotiates investigator budgets at site level, if applicable.
Tracks costs at site level and ensure payments are made, if applicable.
Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff.
CRA, Clinical Research Associate, Clinical Trial Monitor, Sub-Investigator, Investigator, Assistant Professor, Remote CRA, Inhouse-CRA, CTA, Clinical Trial Assistant, Clinical Research, Clinical Trials, Clinical Studies, Hospitals, Medical University, Pharmaceutical, CRO, Pharma, Contract Research Organisation, Biotech, Health, Monitoring, Kiev, Ukraine
DOCS has partnered with a highly prestigious organisation with one of the most robust pipeline within the industry. We have a great job opportunity for a physician/medical doctors who are ready to further develop their career and enjoy working for a global organisation in their offices in Kiev, Ukraine.