Clinical Research Associate

Sotalent; New York (NY); On-site; USD 75,000 - 175,000; Full time

Job summary

Sotalent is seeking an experienced Clinical Research Associate (CRA II) to monitor solid tumour oncology studies and support clinical development in a contract research setting. The role requires on-site monitoring experience, attention to protocol compliance, and effective collaboration with investigators, site staff, and study teams.

You will ensure quality data, participant safety, and timely delivery of milestones while navigating regulatory standards and study requirements.

Qualifications

• Bachelor's degree or equivalent in life sciences/related field.
• At least one year of hands-on, on-site CRA monitoring experience.
• Experience in oncology studies with solid tumours is preferred.
• Solid knowledge of GCP/ICH regulatory standards and quality practices.

Responsibilities

• Coordinate and conduct site qualification, activation, routine monitoring and study closure visits.
• Review site activities to ensure alignment with GCP/ICH and regulatory requirements.
• Support site recruitment plans and training for site staff on study procedures.
• Track monitoring findings, follow-up actions and TMF/ISF documentation.
• Collaborate with project teams to maintain timelines and data quality.

Skills

On-site monitoring

Oncology trials

GCP & regulatory knowledge

Communication

Travel willingness

Education

Bachelor's degree in life sciences/related

Job description

We are looking for an experienced Clinical Research Associate (CRA II) to support the delivery of clinical studies in solid tumour oncology. This opportunity is suited to a clinical research professional who has at least one year of hands‑on, on‑site monitoring experience and is confident working with investigative sites, study teams, and clinical research documentation.

The successful candidate will help ensure that clinical trials are conducted in accordance with approved protocols, applicable regulations, and recognised quality standards. Through regular site engagement, careful review of study records, and proactive management of emerging issues, the CRA will contribute to participant safety, reliable clinical data, and the timely delivery of research milestones.

This position offers the opportunity to work across clinical development programmes within a contract research environment supporting biotechnology companies and their efforts to advance new treatments.

Key Duties and Responsibilities

Clinical Site Oversight

• 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.

Site Collaboration and Participant Recruitment

• 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.

Study Documentation and Data Quality

• 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.

Project Coordination

• 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.

Essential Qualifications and Experience

Candidates should meet the following requirements:

• 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.

The ideal candidate will demonstrate:

• 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.

About the Organisation

The employer operates within the clinical research and healthcare intelligence sector, supporting pharmaceutical and biotechnology organisations throughout the development of new medical treatments. Its work combines clinical trial services, healthcare data, and scientific expertise to help sponsors make informed decisions and progress therapies through development.

The clinical monitoring team works with research sites and project stakeholders to maintain high standards of trial conduct, documentation, and data integrity.

The employer is committed to providing fair and equitable employment opportunities. Applicants will be considered without discrimination on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.

Recruitment Integrity

Applicants are expected to provide accurate, complete, and truthful information throughout the recruitment process. Misrepresentation of qualifications, employment history, professional credentials, or other material information may result in withdrawal of an employment offer or termination of employment, subject to applicable law.

Compensation and Benefits

The anticipated annualised base salary range for this position is $74,500 to $175,100.

The final offer will depend on relevant factors, including the candidate's qualifications, clinical monitoring experience, technical knowledge, geographic location, and whether the position is full‑time or part‑time.

Depending on the role and applicable compensation arrangements, additional remuneration may be available through incentive programmes, bonuses, or other compensation components. Eligible employees may also receive health coverage, welfare benefits, and other employment‑related benefits.