Project Manager

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

📋 Description

• Support researchers with the submission and initiation of human subject studies to scientific and Institutional Review Board (IRB) review committees.

• Prepare applications for committees and gather necessary documents for evaluation.

• Act as the main contact for faculty, staff, and sponsors regarding trial submissions, approvals, and activations.

• Oversee initial study submissions and secure endorsement from the Disease/Modality Team.

• Communicate with sponsors and submit research proposals to external IRBs such as WIRB and/or NCI CIRB.

• Manage ongoing regulatory obligations, including deviations, continuous reviews, and adverse event reporting.

• Collaborate with investigators and Clinical Trials Support Services on budget creation, Medicare coverage analysis, and OnCore calendar setups.

• Ensure prompt study initiations and provide sponsors with necessary regulatory documentation.

• Guide and mentor regulatory coordinators.

• Assist with the onboarding, training, and implementation of new procedures or modifications.

• Coordinate submissions for clinical trials, including obtaining approvals from IRB/DSMC/PRMC/WIRB/CIRB, preparing informed consent documents, and fulfilling activation criteria.

• Maintain regulatory documents and ensure adherence to institutional, state, federal, sponsor, FDA, and NCI standards.

• Collaborate with investigators, research teams, sponsors, IRBs, clinical departments, and other internal stakeholders.

• Facilitate team meetings, monitor deadlines and regulatory progress, participate in professional gatherings, and undertake additional clinical research responsibilities as assigned.

⛳️ Requirements

• Bachelor's degree.

• At least 2 years of experience in regulatory management and the conduct of oncology clinical trials within an academic environment.

• Familiarity with clinical trials.

• Understanding of federal, state, and local regulations.

• Knowledge of IRB requirements.

• Experience in developing consent forms and protocols.

• Proficient in the regulatory and operational aspects of clinical trials.

• Awareness of institutional, federal, and state policies.

• Capability to coordinate approvals and activation requirements for IRB/DSMC/PRMC/WIRB/CIRB.

• Understanding of regulatory documentation along with FDA and NCI requirements.

• Experience or capability to assist in budget development, Medicare coverage analysis, and OnCore calendar setups.

🏝️ Benefits

• Comprehensive benefits (details provided via employer benefits link).

• Equal opportunity employer.