Clinical Research Associate

SoTalent is recruiting for an employer that is not identified by name. The Clinical Research Associate will monitor solid tumour oncology trials, oversee site compliance and data quality, support participant recruitment, and coordinate with sites and study teams throughout the study lifecycle.

Responsibilities

Coordinate and conduct site qualification, activation, routine monitoring, and study closure visits in accordance with study requirements, contractual obligations, and applicable monitoring plans

Evaluate site readiness and ongoing performance, identifying potential risks to participant protection, protocol compliance, and data quality

Review study activities and documentation to confirm alignment with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidance, and relevant regulatory requirements

Identify deviations, operational concerns, and quality issues, ensuring appropriate documentation, follow-up, and escalation

Maintain accurate records of monitoring activities, findings, outstanding actions, and communications with research sites

Establish effective working relationships with investigators and site personnel to support consistent study delivery

Help sites develop and implement recruitment plans that reflect enrolment targets and study timelines

Monitor recruitment progress and identify barriers that could affect enrolment or participant retention

Provide guidance on protocol requirements, study procedures, and trial-specific processes

Deliver appropriate training to site staff and address questions or operational challenges as they arise

Review site records and study data for completeness, consistency, and compliance with protocol requirements

Track participant enrolment, regulatory submissions, clinical data entry, and outstanding data queries

Follow up with sites to support the timely resolution of discrepancies and missing information

Verify that essential trial documentation is maintained appropriately within the Trial Master File (TMF) and Investigator Site File (ISF)

Prepare monitoring reports and maintain clear correspondence documenting findings, agreed actions, and follow-up activities

Work closely with clinical project managers and other study stakeholders to maintain alignment with study objectives, timelines, and quality expectations

Communicate site-level progress, emerging risks, and operational challenges to the appropriate project team members

Contribute to the identification and implementation of practical solutions to monitoring and site management issues

Where required, assist with site budget administration, collection of invoices, and tracking of study-related financial documentation

Support effective planning and execution of clinical activities throughout the study lifecycle

Benefits

Additional remuneration may be available through incentive programmes, bonuses, or other compensation components, depending on the role and applicable compensation arrangements.

Eligible employees may receive health coverage.

Eligible employees may receive welfare benefits.

Eligible employees may receive other employment-related benefits.

Company

Recruitment media and candidate acquisition for employers

New York, US

https://sotalent.us/

Founded in 2020

2-10 employees

Qualifications

a clinical research professional who has at least one year of hands-on, on-site monitoring experience

A bachelor's degree in life sciences, healthcare, or a related discipline, or an equivalent combination of relevant education and experience

At least one year of practical experience conducting on-site clinical trial monitoring visits

Previous experience monitoring oncology studies involving solid tumours

Working knowledge of GCP principles, ICH guidance, and the regulatory standards governing clinical research

The ability to assess clinical site compliance, identify discrepancies, and manage follow-up actions effectively

Strong written and verbal communication skills, with the ability to engage professionally with investigators, study coordinators, and internal stakeholders

Good organisational skills and the ability to manage competing priorities while meeting study deadlines

Willingness and ability to travel in line with assigned study requirements

A methodical and quality-focused approach to clinical trial oversight

Sound judgement when evaluating site performance and escalating potential risks

Attention to detail when reviewing clinical data and essential documents

The ability to work independently while contributing effectively to multidisciplinary project teams

A proactive approach to resolving issues and maintaining productive relationships with research sites

A strong commitment to participant safety, ethical research practices, and the reliability of clinical study results

A clinical research professional who has at least one year of hands-on, on-site monitoring experience

At least one year of practical experience conducting on-site clinical trial monitoring visits.

Required skills

On-Site Clinical Trial Monitoring, Solid Tumor Oncology, Clinical Practice (GCP), International Council for Harmonisation (ICH) Guidance, Clinical Research Regulatory Requirements, Organization and Prioritization

Experience

1+ years