Clinical Research Associate II / Sr. CRA, West Coast US

Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.

At Rho, you’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to take risks, innovate, and develop over a long and rewarding career. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.

We are currently hiring a Clinical Research Associate II or Senior Clinical Research Associate in experience in monitoring pain studies to join our team! As our next CRA II or Senior CRA, you will play an integral to 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).

Our Clinical Monitoring team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!

What you'll be doing:

• 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

Requirements

• BA/BS, preferably in a life science, nursing, pharmacy or related field, along with approximately 2 years (CRA II) or 4-5 years+ (Senior CRA) 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.
• Committed to Quality: 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. This includes strong organization skills, ensuring effective management of multiple sites and protocols within timeframes and on budgets
• High-Character: Contribute to our collaborative culture with honesty and integrity with a willingness to learn and train. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another.
• Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience. We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions.
• Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment. We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us.