Clinical Research Associate II – Oncology

This is a fully remote position, open to applicants in Michigan.

📋 Description

• Acts as the main point of contact for the investigative site.

• Performs site evaluations, training, routine monitoring, and site closure activities.

• Aligns, instructs, and motivates the site personnel and principal investigator.

• Develops a thorough understanding of the therapeutic area, asset, and clinical landscape/patient journey.

• Ensures the integrity and quality of data submitted by study sites.

• Safeguards the safety of study participants.

• Oversees investigator payments in accordance with contractual obligations.

⛳️ Requirements

• At least 1 year of experience in a clinically related field.

• A minimum of 6 months experience in clinical research monitoring of investigational drug or device trials is required.

• Familiarity with a risk-based monitoring approach.

• Knowledge of relevant therapeutic area indications is preferred.

• In-depth understanding of current and emerging local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.

• Excellent cross-functional collaboration skills with both internal and external stakeholders.

• Strong capability to utilize technology, tools, and resources effectively.

🏝️ Benefits

• Medical, dental, and vision insurance.

• 401(k) plan available to eligible employees.

• Paid time off for vacation, holidays, and sick leave.

• Opportunity to participate in short-term incentive programs.