Primary Function:

The Clinical Research Associate will play a key role in providing operational support to coordinate the conduct and data management of clinical studies to ensure compliance with Intuitive Fluorescence Imaging LLC, standard operating procedures, Good Clinical Practices (GCP), good documentation practices, and applicable regulations.

The ideal candidate will have good understanding of clinical trials regulatory requirements.

Roles and Responsibilities:

• Collaborate with internal stakeholders and key opinion leaders (KOLs) to develop and review study concepts, protocol and study outlines and subsequently driving identified initiatives.
• Responsible for the planning and execution of the clinical studies including investigator selection, analysis of potential patient recruitment, creation of study related documents (protocols, case report forms, informed consents, clinical trial agreements, monitoring plan), organizing Institutional Review Board (IRB) / Ethics Committee (EC) submissions with follow thorough to ensure successful outcome.
• Responsible for independently conducting clinical studies on schedule and within budget while ensuring high quality and compliance.
• Interact with external vendors and sites to negotiate contracts and budgets.
• Track study progress and provide status report on a weekly basis with internal team and vendors.
• Participate in data analysis, interpretation and synthesis, instruction in order to develop clinical study reports and /or support development of scientific publications.
• Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., 21 CFR Part 312, GCP and US and OUS guidelines).
• Conduct literature reviews to stay abreast of scientific knowledge and to determine evidence gaps.
• Collaborate with commercial groups (i.e., marketing) to understand market trends and utilize information to support of business goals through Clinical Affairs activities.
• Author and assist in the development of preclinical and clinical documents including protocols and amendments, Investigator’s Brochures, IRB applications, informed consent forms, statistical analysis plans (SAP), clinical monitoring plans (CMP), Investigational New Drug (IND) Submissions, annual reports and clinical study reports.
• Design and assist in the development, review and pre-validation of case report forms (CRFs), electronic data capture strategies (EDC with eCRFs), and clinical study databases.
• Establish, organize, and maintain trial master file and clinical trial management system to ensure regulatory and protocol compliance including maintenance of study essential documentation (e.g., correspondence, CRFs, study approval documents, curriculum vita), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget).
• Support payment and budget tracking of clinical sites and vendors.
• Prepare and ship site binders and patient binders as necessary.
• Responsible for data trial data management and working with documentation specialist to archive and store clinical trial data.
• Coordinate and manages ordering, shipping, labeling and tracking of study supplies (including investigational products) 

Skill/Job Requierements:

• Excellent communication, organization, and interpersonal skills with strong attention to detail.
• Minimum Bachelor’s degree, Masters or PhD is a plus.
• Strong ability to organize, prioritize and manage multiple priorities.
• Prior experience in Pharmaceutical sciences
• Prior experience in medical device clinical trials, regulatory support, clinical project coordination is preferred.
• Clinically savvy and good knowledge of basic medical terminology is preferred
• Possess working knowledge of Good Clinical Practice as detailed in 21CFR and ISO 14155, and regulation such as 21 CFR Part 812.
• Minimum of 2 years of related experience in clinical research with high school diploma or secondary education or equivalent.
• Research/clinical trial management certification/education is a plus.
• Proficient in MS Office suite, Adobe, video and web conferencing solutions
• Able to travel 25% of time

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.