Senior Clinical Research Associate - Remote Oncology Trials

Parexel; Denver (CO); Remote; USD 90,000 - 120,000; Full time

Job summary

Parexel is seeking an experienced Clinical Site Monitoring professional to oversee monitoring activities across oncology and non-oncology trials. You will manage site activation, monitoring, and closeout, coordinating with study teams to ensure compliance with SMP, SOPs, and GCP standards.

The role requires 60-80% travel, strong regulatory knowledge, and fluency in English with additional local language skills. A life sciences degree and oncology experience are preferred.

Qualifications

• Extensive knowledge of clinical trial methodologies and regulations (ICH/GCP/FDA).
• Minimum 3 years monitoring experience in clinical research (2 years in Oncology).
• Preferred experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases.
• Global clinical trial experience.
• Fluency in English and local language(s).
• Significant travel (60-80%) within area; some international travel.

Responsibilities

• Oversee monitoring responsibilities and study conduct to meet SMP requirements and timelines.
• Manage operational aspects at investigator sites from activation to database lock.
• Serve as primary contact for sites and coordinate with SCP for site delivery.
• Facilitate information flow among study team, vendors, and sites.
• Provide protocol training and address protocol questions from site staff.
• Attend investigator meetings and support enrollment and recruitment initiatives.
• Conduct onsite or remote monitoring per SOPs and SMP.
• Monitor AEs/SAEs and liaise with Drug Safety for resolution.
• Submit TMF docs, site reports, deviations, and progress metrics.

Skills

Clinical monitoring

GCP knowledge

FDA/regulatory knowledge

Oncology experience

Travel 60-80%

English fluency

Communication skills

Audit/CAPA

Training/mentoring

Education

Bachelor’s degree in life sciences

Job description

Parexel is seeking an experienced Clinical Site Monitoring professional to oversee monitoring activities across oncology and non-oncology trials. You will manage site activation, monitoring, and closeout, coordinating with study teams to ensure compliance with SMP, SOPs, and GCP standards.

The role requires 60-80% travel, strong regulatory knowledge, and fluency in English with additional local language skills. A life sciences degree and oncology experience are preferred.