In-House CRA II

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

📋 Description

• Act as the primary contact for project teams and investigative sites.

• Conduct and document communications with sites, including preparing contact reports for telephone interactions.

• Monitor site performance and collaborate with the CRA to implement action plans.

• Assist with recruitment tracking and discuss potential study risks and opportunities alongside the Project Manager and CTL.

• Support CRAs in preparing for site visits, generating reports, ensuring file quality control, and resolving action items.

• Oversee site maintenance activities ensuring compliance with renewals and local regulatory as well as IRB/IEC requirements.

• Review Case Report Forms and manage query generation/resolution within data management systems.

• Execute designated on-site monitoring responsibilities, including CRF review, SDR/SDV, Site Regulatory File review, and drug accountability.

• Carry out remote monitoring visits, including remote SDV/SDR following MEA training.

• Collaborate with laboratories, sponsors, medical monitors, project teams, and CTAs.

• Provide training to sites via phone or teleconference/web meetings.

• Conduct IVRS/IWRS reviews and reconciliations.

• Organize study visits and manage the shipment of drugs and laboratory samples.

• Manage sites to ensure adherence to protocol compliance, study visits, and timelines.

• Distribute and track clinical trial supplies.

• Input weekly study information in CTMS and assist with status report preparation.

• Support submissions and notifications to Ethics Committees and Regulatory Authorities.

• Facilitate the translation and back-translation of essential documents.

• Complete administrative tasks related to the project, such as tracking recruitment and preparing site documents.

• Attend and present at investigator, sponsor, kick-off, and face-to-face meetings.

• Ensure adherence to Fortrea SOPs and local regulatory standards.

• Perform any other assigned duties.

⛳️ Requirements

• A university or college degree in biological or life sciences is preferred, or certification in a related allied health profession from an accredited institution (e.g., nursing licensure, medical or laboratory technology).

• Alternatively, 2 or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered.

• At least 2 years of industry experience in a related position.

• Basic understanding of ICH-GCP guidelines.

• Fundamental comprehension of the clinical trial process.

• Capacity to monitor study sites following protocol monitoring guidelines, SOPs, ICH Guidelines, and GCP.

• Ability to work effectively within a project team.

• Strong planning, organization, time management, and problem-solving abilities.

• Excellent oral and written communication skills.

• General proficiency with computers.

• Ability to work efficiently and effectively in a matrixed environment.

• Capability to sit for extended periods and operate a vehicle safely.

• Ability to perform repetitive hand movements and occasional crouching, stooping, bending, and twisting.

• Proficient in using various computer software applications.

• Ability to lift and carry weights of 15–20 lbs.

• Consistent and regular attendance is required.

• Varied hours may be necessary.

🏝️ Benefits

• Option for remote work.

• Participation in the Fortrea Monitoring Excellence Academy (MEA) training program.

• Opportunities for travel, including both domestic and international.

• Commitment to equal employment opportunities and support for accommodations.