Senior Clinical Research Associate

This is a fully remote position, open to applicants in Iowa, +6 more states.

📋 Description

• Oversee and nurture trusted relationships with sites, executing on-site and remote monitoring activities for Phase I–IV clinical trials.

• Facilitate the initiation, progression, and timely completion of trials in accordance with ICH/GCP, local regulations, SOPs, and monitoring protocols.

• Act as the primary site manager and the initial point of contact between site personnel and Novartis.

• Foster collaboration, achieve milestones, and deliver results as a key liaison.

• Manage designated sites and networks in line with monitoring plans and Novartis protocols.

• Conduct site initiation visits and offer ongoing training to site staff.

• Perform ongoing on-site and remote monitoring to ensure compliance with protocols, GCP, regulatory requirements, process integrity, and patient safety.

• Aid in the preparation and collection of site- and country-specific documents.

• Identify potential risks, resolve issues, and escalate concerns when necessary.

• Collaborate with cross-functional teams to enhance study execution and implement process improvements.

• Provide timely, high-quality, and dependable site data to support Trial Monitoring objectives.

• Collaborate with SSU CRA to ensure a smooth transition of site responsibilities.

• Serve as a subject matter expert across study activities as needed.

• Assist in audit and inspection readiness activities, as well as in the implementation of corrective actions.

⛳️ Requirements

• Minimum of 3 years of experience in site monitoring.

• Bachelor’s degree in a Scientific, Healthcare, or related field.

• Comprehensive understanding of the drug development process, particularly in clinical trials and research.

• Familiarity with international standards (GCP/ICH, FDA, EMEA).

• Proven ability to manage multiple priorities and utilize time effectively.

• Strong site management skills, demonstrating effective negotiation and problem-solving abilities.

• Excellent communication and presentation skills, both oral and written.

• Proficient in both written and spoken English.

• Must possess a valid and unrestricted driver’s license.

• Willingness and ability to travel by plane or car up to 80% of the time.

• Experience in RLT, CAR T, or Oncology is a plus.

🏝️ Benefits

• Performance-based cash incentive.

• Eligibility to be considered for annual equity awards, depending on role level.

• Health benefits.

• Life benefits.

• Disability benefits.

• 401(k) plan with company contribution and match.

• Vacation time.

• Personal days.

• Holidays.

• Additional leave options.

• Reasonable accommodations for qualified individuals with disabilities.