Senior Clinical Research Associate-Oncology

Senior Clinical Research Associate

• Opportunity:

Direct Hire / Full Time

• Schedule:

Monday – Friday, 8:00 AM – 5:00 PM; preferred Western region of USA

• Location:

Fully Remote

• Salary Range:

$120,000\.00 - $125,000\.00 annually; 12% annual bonus potential

• Travel:

Willingness to travel up to 75%

Kelly Science and Clinical

is hiring a Sr CRA for one of our clinical-stage biopharmaceutical clients who is dedicated to advancing immunotherapy innovations. Join our client and shape the future of cancer immunotherapy; one patient at a time!

As a Senior Clinical Research Associate, you will play a key role in supporting Clinical Operations by ensuring site management and monitoring activities comply with GCP guidelines, regulations, and SOPs:

• Site Management:

Support clinical trial site feasibility and site selection processes.

• Monitoring:

Conduct all aspects of clinical monitoring, including site qualification, initiation, routine monitoring, and close-out visits.

• Documentation:

Support the maintenance of Investigator Site Files and sponsor Trial Master Files (eTMF).

• Reporting:

Prepare accurate and timely trip visit reports.

• Trial Oversight:

Review progress of clinical trials, especially patient recruitment and data capture, and initiate appropriate actions to achieve objectives.

• Collaboration:

Participate in regular clinical trial team meetings and act as the primary contact for clinical trial supplies and vendors.

• Presentations:

Organize and make presentations at Investigator Meetings.

Secondary Functions:

• Mentor less experienced or new CRA colleagues.
• Perform Clinical Trial Manager (CTM) tasks as appropriate and as delegated.
• Contribute to continuous improvement of Clinical Operation processes and templates.

Required Experience and Education

• Education:

Minimum Bachelor’s Degree, preferably in life science or nursing, or equivalent.

• Experience

: At least 4 years of on-site monitoring experience in the pharmaceutical or biotechnology industry (including all monitoring visit types).

• Required experience monitoring oncology trials

focused on

cell therapy

such as but not limited to

CAR-T, melanoma, and gynecology cancers

to name a few focused areas

• Phase III experience is required
• Compliance:

In-depth knowledge of ICH-GCP, FDA, and EMA and applicable local regulations and laws.

• Technical Skills

: Demonstrated computer skills, including Microsoft Office and clinical trial systems such as eTMF and CTMS.

• Soft Skills

: Exceptional attention to detail and advanced presentation and organizational skills.

• Authorization:

Legal eligibility to work in the United States is required.

Our client believes in investing in their team’s health, safety, and well-being

• Comprehensive Benefits:

Competitive rates for Health, Dental, and Vision Insurance.

• Paid Time Off:

4 weeks of PTO (granted up front), 56 hours of Sick Time, and 12 Paid Holidays.

• Financial Security:

401(k) with immediate eligibility and company match (up to 5% based on tenure).

• Insurance:

100% employer-paid Life Insurance and Short- and Long-Term Disability coverage.

• Growth:

Opportunities to work with leading experts in the field of T-cell immunotherapy and company-provided learning and development opportunities.