The Senior Clinical Research Associate reports to Senior Manager Clinical Research and is responsible for independently managing study activity from site selection and start-up to close out with adherence to regulations, maintaining data integrity and aligning deliverables with corporate goals. 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 and efficiency of data documentation and collection. Initiates and maintains liaison with investigators, site clinical coordinator(s), and 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.
Manage IRB submissions and communications throughout the study duration.
Record and track clinical trial studies in online government databases. (www.clinicaltrials.gov)
Independently perform site qualification, study initiation, site training, interim monitoring and study close-out visits, 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.).
Ensure studies are conducted in accordance with Cutera SOPs, FDA regulations, ICH Good Clinical Practice (GCP) guidelines and other applicable regulations.
Monitor data -- remotely, on site, and via other approved modes – with a focus on data integrity (completeness, accuracy and consistency) and patient safety.
Ensure CRFs and other study documents are obtained from investigators within timelines.
Request any necessary data clarification from investigators. Resolve any data queries/protocol deviations identified within a timely manner.
Ensure AEs are recorded and reported accurately and 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).
Develop and maintain study tracking tools and reporting metrics (on study milestones, site payments, subject payments, study data deliverables, etc.) to supervisory staff.
Undertake other project related tasks, such as support of the Regulatory Department for submissions and annual updates.
Consistently assess clinical research processes and systems for efficiency and compliance.
Knowledge and experience of data management and statistical analysis a plus.
Other duties as assigned.
Education / Training:
B.Sc. in the life sciences or allied health/medical related field, or equivalent experience.
Two years of experience as a Clinical Research Associate, which includes independent on-site monitoring experience from site qualification and study start up through close out.
Two through five years of experience in a clinical research environment, preferably in medical device and/or dermatology or aesthetic space, 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
Must be willing to work on-site at corporate headquarters (Monday through Friday).
Travel up to 30 percent of the time.