Essential Job Duties
The below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties.
1) 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; liaising with vendors; and other duties, as assigned
2) Responsible for all aspects of site management as prescribed in the project plans
3) General On-Site Monitoring Responsibilities
4) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
5) Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
6) Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
7) Monitor data for missing or implausible data
8) Ensure the resources of the Sponsor and Labcorp Drug Development are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses economically according to Labcorp Drug Development travel policy
9) Ensure audit readiness at the site level
10) Travel, including air travel, may be required and is an essential function of the job.
11) Prepare accurate and timely trip reports
12) Responsible for all aspects of registry management as prescribed in the project plans
13) Undertake feasibility work when requested
14) Participate in and follow up on Quality Control Visits (QC) when requested
15) 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 the supervisor
16) Might be requested to work in a client-facing environment
17) Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE
18) Independently perform CRF review; query generation and resolution against established data review guidelines on Labcorp Drug Development or client data management systems as assigned by management
19) Assist with training, of new employees, e.g. co-monitoring
20) Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
21) Perform other duties as assigned by management
Experience
At least one year of clinical monitoring experience
Have a full understanding of the 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 prioritize workload for self and team
Ability to work within a project team
Works efficiently and effectively in a matrix environment
Valid Driver’s License
Education/Qualifications/Certifications and Licenses
Minimum Required:
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
Thorough knowledge of regulatory requirements
Thorough understanding of the drug development process