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Role Description

We are looking for a Clinical Research Associate II (with Post Operative Pain experience) to join our team. As our next Clinical Research Associate II, 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.

• Perform all site monitoring activities, inclusive of all study visit types (PSV, SIV, IMV, and COV) across multiple protocols with the opportunity to gain diverse therapeutic experience
• 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

Qualifications

• BA/BS, preferably in a life science, nursing, pharmacy or related field
• 2-4 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
• Previous clinical experience in acute and/or post-operative pain
• 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 and understanding of high-quality scientific standards
• High-Character: Contribute to a collaborative culture with honesty and integrity
• Critical Thinker: Evaluate situations and opportunities objectively and incisively
• Agile and Adaptable: Ability to change quickly and embrace risk

Requirements

• Proven monitoring skills to conduct site visits to assess site adherence to protocol and regulatory requirements
• Manage required documentation and ensure data remains audit ready
• Commitment to conduct 8-10 site visits days per month (up to 80% travel)

Benefits

• Comprehensive benefits package including medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k)
• Paid time off, holidays, parental leave and bereavement leave
• Flexibility to encourage work-life balance