Clinical Research Associate II

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Manages all facets of study site operations to ensure the protection of patient safety.

• Provides direction at both the site and project levels to meet audit readiness standards.

• Updates, monitors, and maintains study-specific trial management tools and systems.

• Oversees site startup processes, including feasibility assessments and recruitment efforts.

• Aids in the negotiation of study budgets and facilitates the execution of investigator contracts.

• Confirms the process of obtaining informed consent.

• Conducts various types of site visits, including pre-study, initiation, routine monitoring, and close-out visits.

• Records activities through confirmation letters, follow-up letters, trip reports, and communication logs.

• Reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.

• Reconciles the contents of the ISF with the Trial Master File (TMF).

• Effectively and proactively communicates with site personnel, as well as Precision Project and Clinical Trial Management.

• Establishes and maintains positive working relationships with investigators and study staff.

• Conducts inventory and reconciliation of investigational products, and oversees their storage and security.

• Identifies issues or risks related to blinded or randomized information concerning investigational products.

• Engages in data review tasks, which include remote EDC CRF and patient profile evaluations.

⛳️ Requirements

• A bachelor's degree or equivalent experience in a scientific or healthcare field.

• At least two (2) years of experience as a Clinical Research Associate (CRA) in a CRO or within the pharmaceutical/biotech sector, or equivalent relevant experience and/or demonstrated competencies.

• Strong communication and organizational skills are crucial.

• Experience in monitoring oncology trials is preferred.

• Demonstrated client-focused approach is essential.

• Familiarity with computerized information systems, electronic spreadsheets, word processing, and email communication.

• Willingness to travel overnight, with an average of up to 60% travel based on regional needs.

• Proficiency in English, and for positions in non-English speaking countries, fluency in the local language is required.

🏝️ Benefits

• Health insurance.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.

• Discretionary annual bonus.