About The Position

Join Rho, a Clinical Research Organization (CRO) focused on healing, curing, and solving major health challenges. Rho offers a stable and collaborative environment where employees are empowered to take risks, innovate, and grow. This role is for a Clinical Research Associate II with Respiratory experience, who will be integral to project success by performing and coordinating all aspects of clinical monitoring and site management. Responsibilities include conducting site visits, ensuring data audit readiness, and adhering to regulatory requirements and company SOPs. This is a remote position requiring travel for site visits.

Requirements

  • BA/BS, preferably in a life science, nursing, pharmacy or related field
  • Approximately 2 years+ of on-site monitoring experience within the CRO, pharmaceutical, or biotechnology industry
  • 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
  • Committed to Quality: Attention to detail, deep understanding of high-quality scientific standards, ability to care about every outcome, 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. Value a strong team spirit highlighted by loyalty, accountability, and mutual trust. Work smart together, work hard together, and laugh together. Take responsibility for our actions, forgive honest mistakes and respect one another.
  • Critical Thinker: Evaluate situations and opportunities objectively and incisively; craft novel, practical solutions.
  • Agile and Adaptable: Ability to change quickly. Eagerly anticipate, respond to, and take advantage of changes in our environment. Embrace risk but manage it by planning, accepting, and learning from both failures and successes.

Nice To Haves

  • Respiratory experience

Responsibilities

  • 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

Benefits

  • medical
  • vision
  • dental
  • HSA
  • FSA
  • EAP
  • life & disability insurance
  • 401(k)
  • paid time off
  • holidays
  • parental leave
  • bereavement leave
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