Senior Clinical Research Associate

Position Summary:

The Senior Clinical Research Associate reporting to the Director of Clinical Research is responsible for leading and coordinating activities among participating study physicians and maintaining study records. Serving as the primary point of contact for study sites this role oversees the organization and execution of pre and postmarket clinical research studies. The Senior CRA collaborates with research staff to uphold best practices ensuring study integrity and accurate data documentation. Additionally you will establish and maintain relationships with investigators site coordinators and regulatory personnel ensuring compliance with GCP guidelines and all relevant clinical study regulations.

Duties & Responsibilities:

• Lead the development production and compilation of study documents such as protocol case report forms (paper or electronic) informed consent subject questionnaire clinical study reports clinical portions of applicable regulatory submissions IRB submission data management or statistical analysis plans or other controlled documentation.
• Perform site qualification study initiation site training interim monitoring and study closeout visits and complete timely and accurate site visit reports.
• Design forms (electronic or paper based) for receiving processing or tracking data.
• Develop and maintain study and data tracking tools and report study/ data metrics to supervisory staff.
• Track and ensure the timely flow of study documentation and case report forms including inhouse data flow and/or electronic forms transfer.
• Monitor data remotely on site and via other approved modes with a focus on data integrity (completeness accuracy consistency timeliness) and patient safety.
• Create and manage clinical databases and process clinical data including receipt entry verification or filing of information.
• Prepare data analysis listings and activity performance or progress reports.
• Generate data queries and liaise with the study sites to resolve identified problems in a timely manner.
• Prepare and maintain the study essential documents including sponsor and sitespecific regulatory documentation (binders or eTMF)
• Write work instruction manuals data capture guidelines and other study specific standard operating procedures.
• Consistently assess processes systems and technologies for efficiency and compliance with procedures; suggest revision to increase productivity as applicable.
• Analyze clinical data using appropriate statistical tools
• Help record and track clinical trial data on online government databases. ()
• Help select specific software programs for various research procedures and scenarios as needed.
• Train staff on study procedures photography and software program usage.
• Provide support and information to functional areas such as clinical affairs regulatory research & development and marketing.
• Ensure study documentation procedures data collection and analysis are conducted in accordance with Cutera SOPs FDA regulations ICH Good Clinical Practice (GCP) guidelines and other applicable regulations.
• Other duties as assigned.

Qualifications :

Minimum Requirements & Qualifications: 

• B.Sc. in the life sciences or allied health/medical related field or equivalent experience.
• 3 years of experience in a clinical research environment preferred.
• Experience independently running a study from startup through closeout required.
• Experience in the medical device and/or dermatology or aesthetic space preferred.
• Knowledge of GCP guidelines medical terminology and clinical trial processes required.
• Proficient in the use of Microsoft Office Applications (Word Excel PowerPoint etc.)
• Working knowledge of EDC eTMF and/or other clinical research or data management software preferred.
• Experience participating in FDA bioresearch monitoring (BIMO) audits preferred.
• Strong interpersonal and organizational skills.
• Excellent oral and written communication skills.
• Strong organizational skills with attention to details.
• Selfmotivated flexible and independent thinker.
• Ability to work in a fastpaced/demanding environment.
• Problem solver ability to prioritize and/or multitask
• Collaborative team member
• Must be willing to work onsite at corporate headquarters in Brisbane CA (Monday through Friday).
• Travel up to 30 percent of the time.

Additional Information :

Compensation:

Cutera expects to reasonably pay in the range listed below for this position based on the city and state listed in the job posting. The actual compensation is influenced by a wide array of factors including but not limited to skill set level of experience education and candidate residence if the position is remote or fieldbased.

Base salary range:  $110000 $130000

All your information will be kept confidential according to EEO guidelines.

If you are ready to become part of our spectacular growing and FUN company then apply today!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race religion color national origin sex gender gender expression sexual orientation age marital status veteran status or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process perform essential job functions and receive other benefits and privileges of employment. Please contact us to request accommodation.

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.

Remote Work :

No

Employment Type :

Fulltime