Clinical Sub-Investigator (Nurse Practitioner)

Job Summary

We are seeking a skilled and dedicated Clinical Sub-Investigator to join our clinical research team. As a Clinical Sub-Investigator, you will play a critical role in the execution of clinical trials, contributing to the development of new therapies and medical advancements. You will be accountable and responsible for ensuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of subject-generated data, and directing the conduct of research according to federal and state regulations and guidance documents.

Key Responsibilities

• Patient Screening: Screen and evaluate potential study participants for eligibility based on protocol criteria.
• Informed Consent: Obtain informed consent from eligible participants, ensuring that they fully understand the study and their rights.
• Clinical Assessments: Perform medical assessments, physical examinations, and other clinical procedures as required by the study protocol, such as phlebotomy, intravenous infusions, and lab work evaluation.
• Data Collection: Accurately collect, record, and maintain clinical trial data, adhering to regulatory and quality standards.
• Safety Monitoring: Monitor and report any adverse events or side effects experienced by study participants. Perform clinical-related procedures and/or make important trial-related decisions delegated by the Principal Investigator.
• Compliance: Ensure strict adherence to Good Clinical Practice (GCP), local regulations, and ethical standards throughout the study. Manage the activities and performance of the clinical site staff.
• Collaboration: Collaborate closely with the Principal Investigator, study coordinators, and other team members to coordinate and manage the study activities.
• Protocol Adherence: Possess a thorough understanding of the requirements of each study protocol and implement all study procedures as outlined.
• Study Documentation: Create, maintain, and organize study documentation, including study files, source documents, case report forms, organizational SOPs, and guidance documents. Ensure all essential documents, including Investigator Site File (ISF) are accurate and up to date.
• Communication: Provide clear and timely communication with study participants, sponsors, and regulatory authorities as required.
• Education: Stay updated on relevant clinical research developments and participate in continuing education opportunities to enhance your clinical knowledge and skills.
• Any other matters as assigned by management.