|Site:||Naval Medical Center San Diego|
San Diego - San Diego County|
|Employment Type:||Full Time|
|The Clinical Research Associate II will be supporting the Naval Medical Center San Diego Ophthalmology’s Refractive Surgery Center on various research projects. |
This position will serve as a protocol coordinator and will be the primary contract for admistrative issues pertaining to the Patient Reported Outcomes with LASIK (PROWL-1) study, a collaborative protocol of the US Navy, Food and Drug Administration (FDA), and the National Institute of Health (NIH).
This is a contract solicitation position.
|-Serve as primary contact for administrative issues pertaining to the Patient Reported Outcomes with LASIK (PROWL-1) study, a collaborative protocol of the US Navy, Food and Drug Administration (FDA), and the National Institute of Health (NIH).|
-Inform prospective subjects about available research studies at the Navy Refractive Surgery Center as they complete their routine preoperative exams in the clinic.
-Provide informed consent counseling for Navy Refractive Surgery Center research studies should a subject agree to enroll.
-Enter and track research data in various electronic and hardcopy databases while ensuring quality assurance of the data.
-Review and update study records, study-related datasets, and other documents for accuracy and completeness, and identify and resolve any discrepancies/inconsistencies.
-Notify patients when it is time to complete their required study questionnaires and examinations.
-Maintain study consents, research binder, and other documents as required by the IRB and the FDA.
-Assist the Principal Investigator in preparing and presenting Annual Study Reviews as required by the IRB.
-Assist the Principal Investigator in preparing for FDA site visits to Navy Refractive Surgery Center as required.
-Aid in the statistical analysis of data, prepare tables and graphs of results, and participate in manuscript preparation.
-Organize and store medical records, worksheets, Case Report Forms (CRFs), Data Clarification Forms (DCFs), and other study data forms.
-Other duties related to coordinating research studies at Navy Refractive Surgery Center San Diego as required.
|-Possess a Bachelors of Science degree from an accredited university or minimum of two years experience in ophthalmic/vision research coordination.|
-Proof of completion of Responsible Conduct of Research (RCR) course from the Collaborative Institutional Training Initiative (CITI).
-Basic knowledge of Windows-based computer systems and applications to include Microsoft Word, Excel, PowerPoint, Access, and Outlook email.
-Must read, write, speak, and understand the English language fluently and maintain good communication skills with patients and other health care personnel.
-Two letters of reference written within the past six months attesting to the contract worker's experience in an ophthalmic/vision research setting. Letters must be from practicing eye care professionals (ophthalmologists/optometrists), scientists, professors, and/or research managers. Letters must include the name, title, and telephone number, date of reference, address and signature of the individual providing the reference.