The Senior Clinical Research Associate will design, plan and implement the overall direction of clinical research projects. The primary responsibility is to assist the study team with all operational activities for new and/or on-going infectious disease and cancer diagnostic test product clinical evaluations.
- Independently responsible for all activities of the clinical trial including clinical site selection, study initiation visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness, and clinical report preparation and presentation.
- Devise and write study protocols, investigator manuals, site specific instruction manuals and design case report forms for new and modified products.
- Prepare clinical reports and clinical/non-clinical sections of regulatory submissions and prepare scientific abstracts, posters and publications arising from the trials.
- Assist with the management of key study parameters (i.e. start-up activities, enrollment, data collection, etc.)
- Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem.
- Maintain a high level of familiarity with clinical literature in field of study and related areas and stay up to date on major advances in infectious disease diagnosis and cancer detection and the use of new tests and advances in clinical practice.
- Bachelor's degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent.
- Minimum of 5 to 8 years experience with monitoring In Vitro Diagnostic (IVD) products.
- Excellent knowledge of good clinical trial design, including the number and types of subjects and specimens that will be required, the conditions under which specimens must be collected, potential interferants for a given disease, and the current gold standard for the diagnosis of that disease.
- Experience in all aspects of a clinical trial including, but not limited to, clinical site selection, study visits, preparation of study contracts and budgets, and drafting study-specific documents (study protocol, monitoring plan, case report forms, etc.).
- Excellent oral and written communication skills.
- Must remain current with regulatory and clinical requirements for diagnostic products and translate the regulatory requirements into clinical trials.
- Must also know who the thought leaders are for a given disease condition and the institutions with access to the required study populations.
- Knowledge of GCP & ICH guidelines and FDA regulations.
- Basic understanding of statistics.
- Must be able to develop strong rapport with investigators and site staff.
- Travel requirements of 20-40%.
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