Clinical Research Coordinator II - Cell Engineering & Therapy

Responsibilities

• Aid Principal Investigators in study start-up and submissions to appropriate institutional offices.
• Collaborate with the regulatory team to maintain regulatory documentation and administrative files for assigned protocols.
• Ensure compliance with essential regulatory needs to comply with protocol activities.
• Manage supply chain and inventory, including coordination of shipping and receipt of investigational products, biopsies, and other samples.
• Maintain updated training in human research protection rules and regulations, GCP, ICH, etc.
• Comply with various institutional and CICET standard operating procedures involving patient care and trial conduct.
• Coordinate cell therapy-related study enrollment, protocol treatment, and follow-up care for patients participating in clinical trials.
• Ensure timely scheduling of appointments/clinical procedures and pend laboratory orders as per study schedules.
• Work with research nurses, treating physicians, and Principal Investigators to confirm patients’ eligibility as specified in clinical protocols.
• Collect follow-up data on patients' post-treatment as required by the protocol.
• Complete timely research billing review.
• Maintain and update sponsor-related, university and department databases/logs.
• Maintain procedures necessary for timely and complete data management and complies with required supervision tools such as work logs and regular meetings.
• Implement research protocol and CICET agreements for appropriate data management requirements.
• Ensure completeness of patient visit data at each study visit, reconcile data queries, and discrepancies, prospective data entry of ongoing research activities, and other activities related to data management.
• Collaborate with research nurses, study coordinators, and Principal Investigators to ensure data quality, integrity, and compliance with all regulatory, institutional, and department requirements.
• Maintain patient research records and work in conjunction with study teams to gather all required data and relevant clinical information.
• Coordinate monitoring visits by medical monitors, support query resolution, resolve pre-and post-monitoring action items, and review monitoring reports.

Qualifications

• Bachelor's degree in Health Sciences or equivalent in education and experience required.
• Excellent interpersonal and organizational skills.
• Basic knowledge of medical terminology and procedures.
• Strong analytical, critical thinking, and problem-solving skills.
• Ability to exercise professional judgment and discretion in dealing with confidential matters.
• Excellent verbal and written communications.
• Proficient in Microsoft Office Suite and database management.

Preferred Qualifications

• Two years of related experience or equivalent.
• Master’s degree in Health Sciences with related experience or equivalent.
• Experience in clinical research setting with knowledge of HIPAA and GCP.
• Experience with paper Case Report Forms (CRFs) and/or electronic research databases.

Minimum Qualifications

• Bachelor's degree in Health Sciences or equivalent in education and experience required.
• Excellent interpersonal and organizational skills.
• Basic knowledge of medical terminology and procedures.
• Strong analytical, critical thinking, and problem-solving skills.
• Ability to exercise professional judgment and discretion in dealing with confidential matters.
• Excellent verbal and written communications.
• Proficient in Microsoft Office Suite and database management.