The Clinical Research Associate reports to Senior Manager Clinical Research and is responsible for coordinating activities of participating study physicians and maintaining study records. Serves as the principal contact person with study sites, for the organization and conduct of pre- and post-market clinical research studies. Collaborates with other staff in the research setting to help encourage best practices in regards to integrity in the study and accuracy of data documentation and collection. Initiates and maintains liaison with investigators, site clinical coordinator, regulatory and administrative personnel. Ensures the study is conducted according to GCP and all clinical study related regulations.
Responsibilities and Duties:
Participate in the development and preparation of study documents such as Protocol, Case Report Forms, Informed Consent, and Subject Questionnaire.
Assist in IRB submissions and communications throughout the study duration.
Perform study initiation, site training, interim monitoring and study close-out, and complete timely and accurate site visit reports.
Manage study sites to ensure enrollment goals are met in accordance with study protocol and timelines.
Maintain regular contact and communication with sites (investigators and other personnel) during the course of studies to ensure compliance with the protocol and to identify any issues (e.g., slow enrollment, training, excessive staff turnover, site compliance, etc.).
Conduct pre-study site visits for assessment of investigator and site suitability.
Ensure studies are conducted in accordance with Cutera SOPs, FDA regulations, ICH Good Clinical Practice (GCP) guidelines and other applicable regulations.
Ensure CRFs and other study documents are accurately completed by sites and submitted within timelines.
Review of study data for completeness, accuracy and consistency. Request any necessary data clarification from investigators. Resolve any data queries/protocol deviations identified within a timely manner.
Ensure AEs are recorded and reported timely as they arise.
Create databases and perform accurate data entry within requested timelines.
Prepare and maintain the study essential documents including sponsor and site specific regulatory documentation (binders).
Undertake other project related tasks, such as support of the Regulatory Department for submissions and annual updates.
Maintain study tracking tools (study milestones, site payments, subject payments, vendors, etc.) and report metrics to supervisory staff.
Other duties as assigned.
Education / Training:
B.Sc. in the life sciences or related field, or equivalent experience.
Two to five years of experience in a clinical research environment, preferably in medical device, that includes hands-on site management for clinical trials.
Knowledge of GCP guidelines, medical terminology and clinical trial processes required.
Proficient in the use of Microsoft Office Applications (Word, Excel, PowerPoint, etc.)
Strong interpersonal and organizational skills.
Excellent oral and written communication skills.
Strong organizational skills with attention to details.
Knowledge of applicable Quality System Standards
Self-motivated, flexible, and independent thinker.
Ability to work in a fast-paced/demanding environment.
Problem solver, ability to prioritize and/or multi-task
Collaborative team member
Knowledge and experience of data management a plus.
Must be willing to work on-site at corporate headquarters (Monday through Friday).
Travel up to 30 percent of the time.
Applicants responding to this posting must be able to provide proof of eligibility to work in the United States. Competitive salary, benefits, ESPP and stock options. Cutera is an Equal Employment Opportunity Employer.