Clinical Research Associate II​/Sr. CRA; Major Depressive Disorder West Coast

Benefits

Qualifications

• •BA/BS, preferably in a life science, nursing, pharmacy or related field, along with approximately 4-5 years+ of on-site monitoring experience within the CRO, pharmaceutical, or biotechnology industry with a demonstrated understanding of medical/therapeutic area knowledge and medical terminology required for comprehension and execution of clinical protocol
• •Computer literacy, including proficiency in MS Office and use of EDC systems
• •Strong Communicator:
• •Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho's
• •Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome
• •Critical Thinker:
• •Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience
• •Agile and Adaptable:
• •Rho values the ability to change quickly
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Responsibilities

• •As our next CRA II or Senior CRA, you will play an integral role in driving project success
• •You'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Rho Standard Operating Procedures
• •For this role, you'll need proven monitoring skills in order to conduct site visits to assess site adherence to protocol and regulatory requirements as well as manage required documentation
• •You will also be responsible for ensuring the data remains audit ready and able to pass an audit by Rho, the Sponsor, or a regulatory agency
• •This position is a remote role to be located within a 1-hour commute of a US metropolitan airport with the commitment to conduct 8-10 site visits days per month (up to 80% travel)
• •Perform all site monitoring visit activities, inclusive of all study visit types (PSV, SIV, IMV and COV)
• •Participate in the site selection process with oversight from the Clinical Team Lead role
• •Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed, follow-up with sites until deficiencies are resolved
• •Contribute to the development and review of protocols, study tools, and materials as well as documentation for clinical trials
• •Provide mentoring, training, and co-monitoring of junior clinical team members
• •Develop and maintain effective working relationships with clinical sites and within Rho as well as ensure communication of project goals and critical requirements
• •Attend and present at meetings and conferences, including Investigator Meetings
• •Participate in the RFP process, including business development meetings
• •Participate in the Clinical Operations community at Rho by contributing to internal initiatives and standard operating procedures for the administration and monitoring of clinical trials
• •Perform both onsite & remote monitoring and study closure activities across multiple protocols
• •Contribute to our collaborative culture with honesty and integrity with a willingness to learn and train
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