Clinical Research Associate II

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

📋 Description

• Acts as the primary liaison for the investigative site.

• Demonstrates a high level of expertise or experience in providing contextual information regarding clinical trials.

• Aligns, educates, and motivates site staff and the principal investigator.

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

• Possesses an advanced understanding of site engagement and the ability to tailor engagement strategies for assigned studies.

• Collects local/site insights and employs site engagement tools effectively.

• Assesses and ensures effective recruitment and retention strategies based on the patient disease journey.

• Holds an experienced level of competency to mentor and train less experienced Clinical Research Associates (CRAs).

• Undertakes activities as assigned by the manager.

• Conducts continuous risk assessments proactively in collaboration with the Central Monitoring team.

• Implements preventative and corrective action plans as necessary.

• Continuously identifies, evaluates, and recommends new or potential investigators/sites.

• Ensures the quality of data submitted from study sites and guarantees timely data submission.

• Manages investigator payments in accordance with executed contract obligations.

⛳️ Requirements

• Bachelor’s degree or equivalent; a health-related field is preferred (e.g., Medical, Scientific, Nursing, Pharmacy).

• At least 1 year of clinically related experience, including a minimum of 6 months in clinical research monitoring of investigational drug or device trials.

• Familiarity with risk-based monitoring approaches, including both onsite and offsite monitoring.

• Knowledge of relevant therapeutic area indications.

• Advanced understanding of existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.

• Exhibits strong cross-functional collaboration skills with internal and external stakeholders.

• Demonstrates strong planning and organizational abilities.

• Advanced capability to leverage technology, tools, and resources for customer-centric support.

• Excellent interpersonal skills with strong written, verbal, active listening, and presentation abilities.

• Ability to apply functional expertise with appropriate guidance.

🏝️ Benefits

• Paid time off (vacation, holidays, sick leave).

• Medical, dental, and vision insurance.

• 401(k) plan for eligible employees.

• Participation in short-term incentive programs.