Senior CRA – Oncology Site Lead

Parexel; Augusta (ME); On-site; USD 90,000 - 120,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate (Sr. CRA) to manage investigator sites, monitor trials, and drive close-out activities for oncology-focused studies in the United States.

You will ensure patient safety, data quality and adherence to GCP in collaboration with the SCP and study team. This role requires 3+ years of site monitoring experience, strong knowledge of ICH/GCP and FDA regulations, and a willingness to travel 60-80%.

Qualifications

• Minimum 3 years of clinical site monitoring experience.
• Oncology experience preferred.
• Global clinical trial experience preferred.
• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local regulations.
• Fluent in English; knowledge of local language(s) is a plus.
• Travel 60-80% within area required.
• Valid driver’s license and passport required.

Responsibilities

• Ensure proper conduct of clinical trials in accordance with SMP, laws, GCP and sponsor standards.
• Manage site activation through database lock with timelines and quality.
• Serve as primary contact for investigator sites; coordinate with SCP and study team.
• Interface with study team, vendors and investigator sites to ensure information flow.
• Provide training and coaching to site personnel to ensure protocol compliance.
• Attend investigator meetings and support enrollment progress.
• Conduct onsite and remote monitoring per SMP and SOPs.
• Monitor AEs/SAEs and collaborate with Drug Safety Unit for necessary follow-up.
• Submit TMF and site reports within required timeframes.

Skills

Monitoring experience

Oncology experience

Global trials

GCP/ICH knowledge

English fluency

Travel 60-80%

Driver's license

Education

Bachelor's degree in life sciences

Nursing/Pharmacy/Medical degree

Job description

Parexel is seeking a Senior Clinical Research Associate (Sr. CRA) to manage investigator sites, monitor trials, and drive close-out activities for oncology-focused studies in the United States.

You will ensure patient safety, data quality and adherence to GCP in collaboration with the SCP and study team. This role requires 3+ years of site monitoring experience, strong knowledge of ICH/GCP and FDA regulations, and a willingness to travel 60-80%.