Senior CRA, FSP – Surgical / Medical Device

This is a fully remote position, open to applicants in Illinois, +9 more states.

📋 Description

• Oversee and manage clinical study sites, which includes conducting routine monitoring and closeout visits.

• Maintain study documentation and perform pre-study and initiation visits.

• Collaborate with vendors and oversee clinical trial supplies management.

• Ensure that study personnel receive appropriate materials and instructions.

• Confirm adherence to informed consent procedures and protocol compliance.

• Review source documents and uphold data integrity on CRFs and other data management tools.

• Monitor for missing or implausible data entries.

• Execute monitoring tasks effectively in accordance with SOPs and travel guidelines.

• Maintain site-level audit readiness.

• Prepare precise and timely trip reports.

• Manage smaller projects under the supervision of a Project Manager/Director.

• Act as the lead monitor, supporting monitoring plans and reviewing trip reports.

• Assess project progress and initiate actions to meet objectives.

• Organize and present at Investigator Meetings.

• Contribute to the development of protocols and Case Report Forms.

• Participate in writing reports for clinical trials.

• Engage with internal teams regarding needs, resources, and timelines.

• Oversee registry activities and conduct feasibility assessments.

• Conduct, report, and follow up on Quality Control visits.

• Recruit investigators and prepare submissions for ethics committees and regulatory bodies.

• Translate study documentation and arrange meetings.

• Negotiate study budgets and assist with contract agreements.

• Monitor and follow up on Serious Adverse Event reporting.

• Perform CRF reviews and generate as well as resolve queries in data management systems.

• Train, mentor, and develop new staff through activities such as co-monitoring.

• Coordinate clinical projects as a Local Project Coordinator and serve as the local client contact when assigned.

• Execute other duties as assigned by management.

⛳️ Requirements

• Minimum of 1 year of experience in surgical/medical devices.

• At least 3 years of experience in clinical monitoring.

• A university or college degree, preferably in life sciences, or certification in a related allied health profession, nursing, or medical/laboratory technology.

• Relevant equivalent experience may be accepted as a substitute for educational qualifications.

• Comprehensive knowledge of regulatory requirements, including a basic understanding of international regulations.

• In-depth understanding of the drug development process.

• Proficiency in the local office language and English, both written and verbal.

• Complete understanding of Serious Adverse Event (SAE) reporting.

• Advanced skills in site monitoring.

• Advanced capabilities in study site management.

• Advanced skills in registry administration.

• Ability to work independently with minimal supervision.

• Strong planning and organizational skills.

• Proficient computer skills and familiarity with relevant software packages.

• Advanced verbal and written communication skills.

• Ability to train and supervise junior team members.

• Capability to resolve project-related issues and prioritize tasks for oneself and the team.

• Ability to work collaboratively within a project team and matrix environment.

• Valid Driver's License required.

• Regular and consistent attendance is essential.

• Willingness to travel 60–80% overnight, including occasional domestic and international trips.

• Ability to meet the physical demands of the position, including prolonged periods of stationary work, repetitive hand movements, occasional crouching/stooping, bending/twisting, and lifting 15–20 lbs.

🏝️ Benefits

• Flexible remote/home-based work environment.

• 60–80% overnight travel requirements.

• Equal Employment Opportunity (EEO) and accommodations support.