Covance Bulgaria is looking for Senior Clinical Research Associate!
Nr ref.: /JOBS.pl
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
We are currently seeking a proactive, driven Senior Clinical Research Associate to join our expanding CoSource team in Bulgaria.
About the job:
• Site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP • Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP • Assures the implementation of project plans as assigned • Function as leader for projects of limited scope as assigned • Assume line management responsibilities as assigned • Act in the project role of as Local Project Coordinator or Lead CRA as assigned
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned • Responsible for all aspects of site management as prescribed in the project plans • General On-Site Monitoring Responsibilities: o Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study o Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements o 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 implausible data o Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy • Prepare accurate and timely trip reports • Manage small projects under direction of a Project Manager/Director as assigned • Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned • Review progress of projects and initiate appropriate actions to achieve target objectives • Organize and make presentations at Investigator Meetings • Report, write narratives and follow-up on serious adverse experiences • Participate in the development of protocols and Case Report Forms as assigned • Participate in writing clinical trial reports as assigned • Interact with internal work groups to evaluate needs, resources and timelines • Act as contact for clinical trial supplies and other suppliers (vendors) as assigned • Responsible for all aspects of registry management as prescribed in the project plans • Undertake feasibility work when requested • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned • Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned • Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs • Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management • Assist with training, mentoring and development of new employees, e.g. co-monitoring • Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology • In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries • Thorough understanding of the drug development process • Fluent in local office language and in English, both written and verbal
• Minimum of four years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) • In lieu of the above requirements, candidates with > four (4) years supervisory experience in a health care setting and three (3) years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may be considered • Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs • Excellent site monitoring skills • Excellent study site management skills • Excellent registry administration skills • Ability to work with minimal supervision • Good planning and organization skills • Good computer skills with good working knowledge of a range of computer packages • Excellent verbal and written communication skills • Ability to train and supervise junior staff • Ability to resolve project-related problems and prioritizes workload for self and team • Ability to work within a project team • Works efficiently and effectively in a matrix environment
Preferred: • One or more year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred • Local project coordination and/or project management
THERE IS NO BETTER TIME TO JOIN US!
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.