[Hiring] Clinical Research Associate II / Senior Clinical Research Associate @Rho Inc

Role Description

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 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.
• Manage required documentation.
• Ensure 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.

Qualifications

• BA/BS, preferably in a life science, nursing, pharmacy, or related field.
• Approximately 2 years (CRA II) or 4-5 years+ (Senior CRA) 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.

Requirements

• Strong Communicator: Demonstrate written, verbal, and presentation skills to help showcase the successes of your work and Rho’s.
• Committed to Quality: Attention to detail, a deep understanding of high-quality scientific standards, and effective management of multiple sites and protocols within timeframes and on budgets.
• High-Character: Contribute to a collaborative culture with honesty and integrity, willingness to learn and train.
• Critical Thinker: Evaluate situations and opportunities objectively and craft novel, practical solutions.
• Agile and Adaptable: Ability to change quickly, respond to, and take advantage of changes in the environment.

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.
• Encouragement of work-life balance.