Clinical Research Associate II

The Clinical Research Associate II (CRA II) is responsible for overseeing the execution of clinical trials at Investigative Sites. The Clinical Research Associate acts as a liaison between the study Sponsor, CRC and Investigative Sites. They will proactively identify and resolve clinical project issues and participate in process improvement initiatives as applicable. The CRA facilitates successful execution of studies by Investigative Sites and helps to ensure the rights, safety and welfare of human research participants as well as data integrity in clinical trials.

Essential Duties and Responsibilities

• Independently initiates, monitors, and closes investigational sites in accordance with FDA regulations, ICH‑GCP guidelines, study protocols, and company SOPs.

• Manages assigned sites with minimal supervision, ensuring high‑quality monitoring outcomes and acceptable QA and audit readiness.

• Conducts on‑site and remote monitoring visits (SIVs, IMVs, COVs) per the Clinical Monitoring Plan (CMP).

• Performs comprehensive source document review (SDR) and source data verification (SDV) to ensure accuracy, completeness, and protocol compliance.

• Reviews CRFs/eCRFs to identify missing, inconsistent, or erroneous data and ensures timely resolution.

• Generates, tracks, and resolves data queries in collaboration with investigative sites and data management teams.

• Maintains and updates study‑specific non‑CRF tracking databases and supports data collection, entry, cleaning, and reconciliation activities.

• Verifies investigational product (IP) accountability, including storage conditions, dispensing, reconciliation, and shipment tracking.

• Collects, reviews, and maintains essential regulatory documentation to support TMF/ISF completeness and inspection readiness.

• Identifies, documents, and escalates site issues, risks, and protocol deviations, proposing mitigation strategies as appropriate.

• Develops and maintains effective working relationships with Principal Investigators, study coordinators, pharmacists, and site staff.

• Prepares accurate and timely monitoring visit reports, follow‑up letters, and other required study documentation.

• Participates in the development and review of study protocols, CRFs/eCRFs, and monitoring tools, providing operational input.

• Develops and utilizes study tracking tools, monitoring tools, and project management materials to support efficient study execution.

• Serves as lead monitor for assigned studies or protocols, including organizing study files, coordinating monitoring schedules, and supporting study team meetings.

• Assists with day‑to‑day study operations and collaborates cross‑functionally with minimal oversight.

• Mentors and supports junior CRAs or clinical staff as assigned, including training and task oversight.

• Utilizes computer and presentation skills to prepare study communications, newsletters, slide decks, and project management tools.

• Travels as required to support study needs in accordance with project and monitoring requirements.

• Performs other duties as assigned.

Qualifications

• Bachelor’s degree, or RN, in a related field or equivalent combination of education, training and experience

• Minimum 2 years’ documented experience as a CRA; experience overseeing clinical trials in the pharmaceutical, hospital or CRO industry

• Ability to work and travel independently with minimal supervision

• Experience with numerous EDC systems

• Strong knowledge of GCPs, ICH guidelines, FDA and other applicable regulations

• Specialized knowledge of CNS therapeutic areas (preferred)

• Proficient in Microsoft Office, Zoom and Adobe

• Effective writing and verbal skills, English language proficiency

• Meticulous attention to detail

• Time management and ability to prioritize tasks

• Ability to travel up to 70%