The Clinical Research Associate (CRA) II manages study activity from site selection, start-up, to close-out with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals associated with the I-SPY Trials – www.ispytrials.org

As a key contributor to the Clinical Affairs team, this position develops and assesses SOPs, assesses processes for efficiency and compliance. This position requires the ability to be detailed-oriented, organized, and productive with a keen interest in pharmaceutical research.

Principal Responsibilities

• Independently manage all phases of a clinical study including protocol, essential document management, contract execution, IRB/EC support, recruitment, and development of site tools.
• Good Remote Data Review skills are required.
• Conducts Qualification, Site Initiation, Interim, and Close-Out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations.
• Train site personnel regarding the protocol and applicable regulatory requirements.
• Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment.
• Facilitate corrective action assessment and maintain TMF in BIMO readiness.
• Provide study status updates to the Management team and develop sufficient resolution of identified action items.
• Contribute to annual reports, data management, data analysis, and publication support.
• Monitor emerging trends to help integrate new requirements into department procedures.
• Maintain current knowledge of applicable US and international clinical regulations and guidance documents.
• Participate in department systems and development initiatives including related trainings.
• Support investigator meetings as needed.
• Ensure CTMS is current and capable of generating reports upon request.
• Support Protocol Deviation and Adverse Event review and reporting.
• Maintain credentialing requirements at hospitals and clinics as needed.
• Complete projects and tasks consistent with corporate objectives.
• Support the Clinical Affairs team in general and with various improvement projects.
• Perform other duties as assigned.
• Contribute to the company culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

Preferred Education and Experience

• Bachelor of Science degree preferably in natural sciences or related field, or related practical experience and at least 5 years of clinical research experience preferably in the pharmaceutical industry. Or a Master’s degree preferably in natural sciences or related field, or related practical experience and at least 3 years of clinical research experience preferably in the pharmaceutical industry. Doctor of Medicine (M.D.) (or medical training equivalent) and at least 18 months of clinical research experience preferably in the pharmaceutical industry.

Preferred Skills

• Knowledge of oncology and infectious Disease or willingness to undergo rigorous and fast learning independently.
• Experience working on adaptive platform trials.
• Excellent time management skills.
• Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified.
• Ability to make critical, independent decisions and be accountable for actions within a fast-moving environment.
• Ability to perform at high-levels with limited supervision and effectively partner with team members when necessary.
• Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria.
• Proficient in Microsoft Word, Excel, and Access and the ability to quickly learn other software tools and applications.
• Ability to develop strong relationships with investigative sites.