Clinical Research Associate – Site Director

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

📋 Description

• Accountable for the effective initiation, oversight, and execution of Phase I-IV studies at designated clinical sites.

• Conduct clinical site management and monitoring tasks in accordance with ICH-GCP principles, standard operating procedures (SOPs), local laws and regulations, study protocol(s), relevant study plans, and operational guidelines.

• Act as the primary liaison for clinical sites throughout all phases, from initiation to closure of clinical studies.

• Coordinate monitoring availability and ensure adherence to data entry timelines at assigned sites.

• Carry out necessary monitoring, including source data verification, and guarantee that site activities are performed within established timelines.

• Build and maintain strong relationships with sites to ensure ongoing collaboration.

• Engage with investigators and site personnel on matters related to protocol execution, recruitment, protocol deviations, inspection readiness, and overall site performance.

• Identify, evaluate, escalate, and resolve site performance or quality concerns promptly.

• Complete feasibility assessments and site selection activities for new clinical studies.

• Conduct start-up and maintenance tasks for assigned sites, including the preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments).

• Support communication with relevant site staff involved in start-up and IRB/EC submissions.

• Assist in site budget and contract negotiations, ensuring timely finalization of necessary clinical trial agreements for assigned sites in partnership with clinical program management and finance.

• Responsible for developing site-specific recruitment, retention, and follow-up strategies.

• Facilitate and assist with investigator site audits and/or inspection activities as needed.

• Conduct remote data reviews and address queries for designated sites.

• Enhance the overall clinical operations team's knowledge by sharing best practices and engaging in improvement initiatives.

• Provide coaching and mentorship to colleagues as necessary.

• Participate in the evaluation of Codera’s systems and procedures when required.

• May assist in other areas of study management and staff training as needed.

• Perform additional duties as assigned.

⛳️ Requirements

• A Bachelor’s Degree in a Life Science discipline is mandatory.

• A Bachelor’s Degree in Nursing or an RN qualification is advantageous.

• A minimum of 3 years of direct site monitoring experience is essential.

• Comprehensive understanding of all facets of clinical site monitoring and overall drug development is required.

• In-depth knowledge of FDA, ICH, and GCP guidelines, along with relevant local regulations, is necessary.

• Strong critical thinking abilities and the capacity to comprehend complex patient histories, medical terminology, and treatment landscapes are essential.

• Ability to analyze study-level metrics data and proactively detect and mitigate risks throughout the study lifecycle.

• Detail-oriented, organized, and dedicated to maintaining quality and consistency.

• Results-oriented and capable of handling competing high-priority tasks with a proven history of meeting deadlines.

• Excellent collaboration skills and the ability to thrive in team environments.

• Ability to adapt in a dynamic setting with a high degree of flexibility.

• Capacity to enhance the culture of process improvement, focusing on streamlining processes that add value to the company’s business needs.

• Strong written and verbal communication skills are crucial.

• Experience and demonstrated proficiency in CTMS and eTMF systems are preferred.

• Must be willing and able to travel up to 50-65% of the time.

🏝️ Benefits

• Employer-sponsored insurance plans, including medical, dental, and vision coverage.

• Generous paid time off.

• Options for retirement plans.

• Additional wellness and professional development programs.