Clinical Research Associate II / Sr. CRA

This is a fully remote position, open to applicants in United States.

📋 Description

• Conduct all site monitoring visit activities, encompassing PSV, SIV, IMV, and COV study visit types.

• Engage in site selection with guidance from the Clinical Team Lead.

• Offer feedback to sites concerning identified deficiencies and necessary corrective actions, ensuring follow-up until resolution.

• Assist in the development and review of clinical trial protocols, study tools, materials, and documentation.

• Mentor, train, and co-monitor junior members of the clinical team.

• Establish and maintain productive working relationships with clinical sites and Rho.

• Communicate project objectives and critical requirements effectively.

• Attend and present at meetings and conferences, including Investigator Meetings.

• Take part in the RFP process and business development meetings.

• Contribute to Rho’s Clinical Operations community, internal initiatives, and standard operating procedures.

• Execute onsite and remote monitoring and study closure activities across various protocols.

• Ensure compliance with protocols and regulatory standards at sites.

• Maintain audit-ready data and documentation that can withstand audits by Rho, sponsors, or regulatory bodies.

⛳️ Requirements

• BA/BS degree, preferably in life sciences, nursing, pharmacy, or a related discipline.

• Approximately 2 years of onsite monitoring experience for CRA II; 4-5+ years for Senior CRA.

• Onsite monitoring experience in the CRO, pharmaceutical, or biotechnology sectors.

• Proven knowledge of medical or therapeutic areas and medical terminology sufficient to understand and implement clinical protocols.

• Proficient in computer use.

• Strong skills in Microsoft Office applications.

• Experience with EDC systems.

• Excellent written, verbal, and presentation abilities.

• Strong organizational skills with keen attention to detail.

• Capability to manage multiple sites and protocols within established timelines and budgets.

• Ability to work collaboratively with honesty, integrity, accountability, and mutual trust.

• Strong critical-thinking and practical problem-solving abilities.

• Flexibility to adapt swiftly to changing environments.

• Must be located within a 1-hour commute of a US metropolitan airport.

• Commitment to conducting 8-10 site visit days per month, with up to 80% travel required.

🏝️ Benefits

• Comprehensive medical, vision, and dental insurance plans.

• Health Savings Account (HSA).

• Flexible Spending Account (FSA).

• Employee Assistance Program (EAP).

• Life and disability insurance coverage.

• 401(k) retirement plan.

• Paid time off.

• Paid holidays.

• Parental leave.

• Bereavement leave.

• Work-life balance and flexibility.