Clinical Research Associate
Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures.
Adhere to monitoring plan protocols, e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates.
Monitor clinical trial progress through a combination of data review and on site monitoring visits.
Verify that trial data is consistent with patient clinical notes and other source
documentation (source data verification/review).
Ensure identification and reporting of safety issues (e.g., Adverse Events, Serious Adverse Events, etc.)
Monitor safety reviews and adverse event reporting for investigational drug to assure adherence to Good Clinical Practices (GCP), FDA and MDD regulations.
Ability to travel extensively, perhaps 25-50% of the time, locally and statewide.
Ensure essential study documents are accurate, complete, and properly organized and stored as quality records.
Independently coordinate ongoing and upcoming monitoring assignments.
Meet expected timelines for completion of monitoring activities and submission of written monitoring reports.
Ensure complete reporting and proper documentation of monitoring activities (e.g., complete monitoring reports in a timely manner, follow up with sites to complete open action items, etc.)
Writes clear, succinct, and detailed clinical study and technical summary reports.
Assist in the development and writing of clinical trial monitoring plans.
Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.
Participate in regular monitoring team group meetings.
Assist in writing study monitoring plan.
Assist in preparing SOPs for clinical trial operation.
Assist in QC study clinical report.
Support project teams to QC IND documents for IND submissions
Education and Experience
Bachelor’s degree in health care discipline or a field related to research compliance. 3+ years of clinical trial study experience with 2+ years of monitoring experience. Knowledge of ICH guidelines, GCP, and the clinical trial study process. Ability to work effectively in teams as well as independently. Strong verbal and written communication. Ability to manage multiple projects at a time.
Essential Skills and Abilities
Must have experience in clinical trials. Experienced in clinical operations and the process of building clinical database. Familiar to ICH guidance for GCP. Should be able to work with minimal supervision. Must be strong in verbal and written skills in English.
Uses computer system for MS Word, Excel, processing, EDC, computer data acquisition, data analysis, graphing and plotting results, report writing, and analysis. Must be able to drive to clinical sites, local and statewide, may require up to 25-50% of time.