Location: Lebanon Junction,KY, USA
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 Labcorp are spent wisely by performing the required monitor tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp travel policy
- 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 Visits (CQC) 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 Labcorp 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 Labcorp or client data management systems as assigned by management
- Assist with training, mentoring and development of new employees, egg. Co-monitoring
- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
- Perform other duties as assigned by management
Education/Qualifications:
Minimum Required:
- External Candidates
- University or college degree, or certificate in a related health profession from an appropriately accredited institution (e.g., nursing licensure),
AND
- A minimum of 4 years of Clinical Monitoring experience.
- In lieu of the above education requirement, external candidates with a minimum of 6 years recent clinical monitoring experience will be considered
- Internal Candidates
- Internal candidates with a minimum of 4 years of clinical monitoring experience
- 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
Preferred:
- Thorough knowledge of Labcorp SOPs regarding site monitoring
Experience:
Minimum Required:
- External Candidates
- University or college degree, or certificate in a related health profession from an appropriately accredited institution (e.g., nursing licensure),
AND
- A minimum of 4 years of Clinical Monitoring experience.
- In lieu of the above education requirement, external candidates with a minimum of 6 years recent clinical monitoring experience will be considered
- Internal Candidates
- Internal candidates with a minimum of 4 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 priorities workload for self and team
- Ability to work within a project team
- Works efficiently and effectively in a matrix environment
- Valid Drivers License
Preferred:
- One (1) or more years 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