The Clinical Research Associate is responsible and accountable for site monitoring and site management. Has responsibility for clinical studies according to Company, and/or Sponsor Standard Operating Procedures, and local regulatory guidelines. Assures the implementation of project plans, as assigned. Act in the project role of a Local Project Coordinator or Lead CRA as assigned.
Essential Job Duties:
1) 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.
2) Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, the conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
3) Responsible for all aspects of site management as prescribed in the project plans
4) General On-Site Monitoring Responsibilities
5) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
6) Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
7) Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
8) Monitor data for missing or implausible data
9) 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 in an economical fashion according to Labcorp Drug development travel policy
10) Ensure audit readiness at the site level
11) Travel, including air travel, may be required and is an essential function of the job.
12) Prepare accurate and timely trip reports
13) Responsible for all aspects of registry management as prescribed in the project plans
14) Undertake feasibility work when requested
15) Participate in and follow up on Quality Control Visits (QC) when requested
16) 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
17) Might be requested to work in a client facing environment
18) Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE
19) 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
20) Assist with training, of new employees, e.g. co-monitoring
21) Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
22) Perform other duties as assigned by management
• A minimum 2 years of Clinical Monitoring experience is required, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted.
• Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory Guidelines
• Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Good planning, organization and problem-solving abilities
• Ability to work with minimal supervision
• Good communication and interpersonal skills
• Good analytical and negotiation skills
• Computer competency
• Fluent in local office language and in English, both written and verbal
• Works efficiently and effectively in a matrix environment
• One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred, however an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
Education/Qualifications/Certifications and Licenses:
• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
• Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements
• Thorough knowledge of monitoring procedures
• Basic understanding of the clinical trial process
• Thorough knowledge of Company SOPs regarding site monitoring