Senior Clinical Research Associate

BioTalent; United States; Remote; USD 126,000 - 154,000; Full time

Job summary

BioTalent in the United States is seeking a Senior Clinical Research Associate (CRA) / Lead CRA to provide leadership and operational oversight for a multi-site clinical trial. This remote role emphasizes team mentoring, monitoring oversight, and cross-functional collaboration across study leadership and PM.

The successful candidate will drive CRA performance, review monitoring visits, ensure TMF completeness, and address site-related issues in partnership with Project Management.

Qualifications

• Extensive hands-on CRA experience supporting multi-center clinical trials.
• Previous Lead CRA or mentoring/oversight experience.
• Strong knowledge of site monitoring visits (SQV/SIV/IMV) and TMF processes.
• Ability to identify and mitigate site risks and operational issues.
• Excellent organizational, communication, and problem-solving skills.

Responsibilities

• Provide day-to-day leadership and operational support to the CRA team.
• Conduct regular one-on-one meetings with CRAs to review progress and address challenges.
• Coordinate regional or global CRA meetings and develop materials.
• Promote consistent monitoring practices and accountability across the team.
• Ensure monitoring activities align with the study monitoring plan and regulatory requirements.

Skills

CRA leadership

Mentoring

Multi-site monitoring

Regulatory compliance

Study leadership collaboration

Job description

Senior Clinical Research Associate (CRA) / Lead CRA

Location: Remote – United States (Eastern or Central Time Zone Preferred)

Employment Type: Full-Time

Salary: $140,000 annually

About the Opportunity

We are seeking an experienced Senior Clinical Research Associate (CRA) / Lead CRA to provide leadership, guidance, and operational oversight to a team of CRAs supporting a complex, multi-site clinical trial across the United States.

This position is ideal for an experienced CRA professional who enjoys mentoring and supporting other CRAs, ensuring consistent monitoring practices, and proactively addressing operational challenges across multiple clinical trial sites.

Unlike a traditional Senior CRA position focused primarily on managing an individual portfolio of sites, this role emphasizes CRA team leadership, monitoring oversight, risk identification, and cross-functional collaboration.

The successful candidate will serve as a key liaison between the CRA team, Project Management, and study leadership to ensure effective trial execution, regulatory compliance, and timely resolution of site-related issues.

Key Responsibilities

• Provide day-to-day leadership, guidance, and operational support to the CRA team.
• Conduct regular one-on-one meetings with CRAs to review progress, address challenges, and provide ongoing support.
• Serve as a primary point of contact for CRA-related questions and operational concerns, escalating issues to Project Management or study leadership when necessary.
• Lead and coordinate regional or global CRA meetings, including preparing agendas, facilitating discussions, and developing meeting materials.
• Promote consistent monitoring practices, effective communication, and accountability across the CRA team.

Clinical Monitoring & Site Oversight

• Oversee clinical monitoring activities across multiple investigational sites to ensure alignment with the study monitoring plan.
• Review Site Qualification Visit (SQV), Site Initiation Visit (SIV), and Interim Monitoring Visit (IMV) reports to ensure quality, completeness, and timely follow-up.
• Track outstanding monitoring action items and drive their resolution.
• Maintain visibility into site performance, monitoring activities, and operational challenges across the study.
• Support site readiness and preparation for upcoming Site Initiation Visits.
• Ensure monitoring activities are conducted consistently and in accordance with study requirements.

Documentation & Compliance

• Oversee the completion, accuracy, and appropriate filing of essential clinical trial documentation.
• Collaborate with CRAs and Project Management to identify and resolve missing or outstanding Trial Master File (TMF) documentation.
• Support oversight of essential documents and site-level regulatory documentation.
• Ensure appropriate follow-up and documentation of monitoring findings and outstanding action items.

Risk Management & Cross-Functional Collaboration

• Identify recurring site-level issues, monitoring trends, and potential operational risks across multiple sites.
• Proactively communicate emerging challenges to Project Management and study leadership.
• Support the development and implementation of mitigation strategies to address identified risks.
• Facilitate effective collaboration between CRAs, Project Management, and other study stakeholders to maintain operational efficiency and study quality.

Qualifications & Experience

Required Qualifications

• Extensive hands‑on Clinical Research Associate experience supporting multi‑center clinical trials.
• Previous experience as a Lead CRA or demonstrated experience mentoring, coordinating, or providing operational oversight to CRA teams.
• Strong understanding of clinical monitoring activities, including Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), monitoring reports, follow‑up activities, and site issue management.
• Experience reviewing monitoring visit reports, identifying deficiencies, and ensuring timely closure of action items.
• Thorough knowledge of clinical monitoring plans, visit compliance requirements, and site‑level risk management.
• Strong understanding of Trial Master File (TMF) processes and essential clinical trial documentation requirements.
• Ability to identify and address trends and operational risks across multiple investigational sites.
• Experience facilitating CRA meetings, conducting individual check‑ins, and supporting team performance.
• Strong organizational, communication, problem‑solving, and clinical operations decision‑making skills.
• Ability to collaborate effectively with CRAs, Project Managers, and study leadership.
• Must be based in the United States.

Preferred Qualifications

• Experience supporting clinical trials in respiratory indications or Neonatal Intensive Care Unit (NICU) populations.
• Experience with clinical trials involving medical devices or drug‑delivery components.
• Located in the Eastern or Central Time Zone.

Ideal Candidate

The ideal candidate is an experienced Senior CRA or Lead CRA who combines strong clinical monitoring expertise with the ability to lead, mentor, and support a team of CRAs.

This individual should be comfortable overseeing monitoring activities across m