Clinical Research Associate II

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

📋 Description

• Conduct Site Evaluation Visits, Site Initiation Visits, Interim Monitoring Visits, and Close Out Visits.

• Develop the study reference manual while collaborating with the Contract Research Organization (CRO) team, which includes central labs, specialty labs, and vendors.

• Ensure that investigator sites comply with all contractual and regulatory requirements prior to site initiation and the initial release of the study drug.

• Contribute to the formulation of study and program plans, such as the Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, and Safety Management Plan.

• Oversee patient recruitment strategies by proactively identifying potential barriers and proposing effective solutions.

• Monitor recruitment, data quality, and patient safety both on-site and remotely through EDC systems and direct communication with sites.

• Collaborate with study site personnel to guarantee the accurate and timely entry of data into the eCRF, addressing data queries promptly.

• Maintain comprehensive project files, which include ethics committee approvals, investigators' curricula vitae, clinical investigators brochures, protocols, case report forms instructions, consent documents, clinical trial material shipping orders, records of start-up meeting attendance, letters of agreement, lab reference ranges, and all correspondence with investigators and sites.

• Identify and follow up on Serious Adverse Events (SAEs) at study sites.

• Assist with data listing, coding, patient profile reviews, database lock, and site close-out procedures.

• Ensure the timely and appropriate submission of documents to the Trial Master File.

• Conduct inventory, reconciliation, and reviews of investigational products (IP), ensuring their storage and security.

• Verify that the IP has been dispensed and administered to subjects/patients in accordance with the protocol, and assess any issues or risks related to blinded or randomized information regarding the IP.

⛳️ Requirements

• Bachelor’s degree in a health science or related field.

• A minimum of 2 years of independent monitoring of Oncology trials.

• Strong verbal and written communication skills are essential.

• Excellent organizational, multitasking, and time management abilities are required.

• Proven experience in developing and maintaining relationships with sites while ensuring compliance.

• Familiarity with the International Conference on Harmonization Good Clinical Practice guidelines.

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint, Teams) and various clinical trial systems (e.g., CTMS, EDC, and eTMF).

• Willingness to travel as required (50-75%).

🏝️ Benefits

• Health insurance coverage.

• 401(k) matching contributions.

• Paid time off.

• Flexible work arrangements.