[Hiring] Clinical Research Associate II / Sr. CRA @Rho Inc

Role Description

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.

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 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).

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
• 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: Ability to evaluate situations and craft novel, practical solutions
• Agile and Adaptable: Ability to change quickly and manage risk

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

Compensation

The range of starting pay for this role is $90,000 to $140,000 per year.