Job details
Job type full-time
Full job description
Job overview:
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:
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
Ensure the protection of study patients 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 implausible data
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
Ensure audit readiness at the site level
Travel, including air travel, may be required and is an essential function of the job.
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 and trip report review as assigned
Review progress of projects and initiate appropriate actions to achieve target objectives
Organize and make presentations at investigator meetings
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
Conduct, report and follow-up on quality control (qc) visits 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
Track and follow-up on serious adverse event (sae) reporting, process production of reports, narratives and follow up of saes
Education/qualifications:
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered.
Thorough knowledge of regulatory requirements
Thorough understanding of the drug development process
Fluent in local office language and in english, both written and verbal
Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
Experience:
Minimum required:
Two (3) years of clinical monitoring experience
Have a full understanding of serious adverse event (sae) reporting, process production of reports, narratives and follow up of saes
Advanced site monitoring skills
Advanced study site management skills
Advanced 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
Advanced 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
Valid driver`s license
Preferred:
One (1) or more year`s additional experience in a related field (i.eMedical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
