Clinical Research Associate

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

📋 Description

• Gather, monitor, and assess investigational site records concerning subject screening and enrollment.

• Support the formulation of study plans and status updates.

• Gather, monitor, and evaluate all site regulatory documentation.

• Aid in the creation and evaluation of Informed Consent Forms.

• Engage with sites, clients, vendors, and internal study team members.

• Oversee the clinical trials management system (CTMS) and other project tracking tools.

• Monitor study supplies and arrange for the shipment of supplies to sites as necessary.

• Manage the Trial Master File (TMF) for the study and ensure regular TMF audits.

• Coordinate efforts with CRAs conducting on-site monitoring.

• Execute on-site co-monitoring and remote monitoring tasks.

• Conduct regular evaluations of data entered by investigational site personnel in line with data review/monitoring protocols.

• Collaborate with the Project Manager, traveling CRAs, and Lead CRA to facilitate clinical trial monitoring activities.

• Assist CRAs with resolving queries and conducting data reviews.

• Ensure that studies are conducted in accordance with study protocols, Rho SOPs, ICH/GCP guidelines, and federal regulations.

• Potentially mentor other team members.

⛳️ Requirements

• Bachelor's Degree in a life science, nursing, or pharmacy field.

• Minimum of 1 year of direct experience managing essential documents within the CRO, pharmaceutical, or biotech sectors.

• Strong understanding of the clinical research process.

• Knowledge of Regulatory and Central/Local ethics submission processes for the designated countries.

• Familiarity with current ICH GCP guidelines and relevant regulations.

• Aspiration to transition into a traveling CRA role.

• Excellent written, verbal, and presentation capabilities.

• Keen attention to detail and a commitment to high-quality scientific standards.

• Integrity and honesty.

• Ability to assess situations objectively and develop innovative, practical solutions.

• Capacity to adapt quickly to changing environments.

🏝️ Benefits

• Medical insurance.

• Vision insurance.

• Dental insurance.

• Health Savings Account (HSA).

• Flexible Spending Account (FSA).

• Employee Assistance Program (EAP).

• Life insurance.

• Disability insurance.

• 401(k) plan.

• Paid time off.

• Holidays.

• Parental leave.

• Bereavement leave.

• Flexibility for work-life balance.