Vitalief Inc.

Project Manager

• Provide operational oversight and coordination for Pediatric Acute Leukemia clinical trials.
• Serve as the primary liaison between pharmaceutical clinical research team and CROs.
• Ensure trials are executed efficiently, on budget, and in compliance with regulatory standards.
• Bridge scientific and operational aspects of clinical research.
• Lead cross-functional teams to deliver high-quality studies.

Clinical Trial Project Manager

• Provide operational oversight and coordination for Pediatric Acute Leukemia clinical trials.
• Serve as the primary liaison between the pharmaceutical clinical research team and CROs.
• Ensure trials are executed efficiently, on budget, and in compliance with regulatory standards.
• Lead cross-functional teams to deliver high-quality studies evaluating safety and efficacy of pharmaceuticals.
• Monitor study activities for compliance with protocols and regulatory requirements.
• Identify potential delays or out-of-scope work and implement mitigations.
• Oversee study documentation, including case report forms, drug records, and regulatory filings.
• Maintain regular communication with sponsors and internal teams.
• Develop realistic budgets and timelines.

Clinical Trial Assistant – Project Manager

Accounting Manager

• Prepare and execute monthly close processes, including journal entries, reconciliations, and financial reporting.
• Process vendor invoices, ensure timely and accurate payments, and maintain accurate AP records.
• Review, process, and record employee and contractor expense submissions with accuracy and timeliness.
• Generate and issue invoices, track collections, and maintain accurate AR records.
• Assist with payroll processing through ADP, ensuring data integrity, accuracy, and adherence to deadlines.
• Identify and recommend opportunities to enhance efficiency and accuracy in financial workflows.

Interim Accounting Specialist

Compliance

• Reporting to the Export Control Manager and AVP for Regulatory Affairs.
• Conduct export control determinations for research projects, agreements, equipment, and material transfers.
• Perform restricted party screenings against U.S. government lists (e.g., BIS Entity List, OFAC SDN List).
• Identify compliance risks and escalate complex issues to the Export Control Manager.
• Assess license requirements and applicability of exceptions/exemptions under EAR, ITAR, and OFAC.
• Assist in the preparation, submission, and monitoring of export licenses and Technology Control Plans (TCPs).
• Ensure ongoing compliance with license terms and conditions.
• Determine appropriate jurisdiction and classification for items, technology, and software.
• Review and interpret export/import documentation, including commercial invoices, bills of lading, ITATA/IMDG, SED, POA, and CBP forms (7501/3461).
• Support compliance reviews of Material Transfer Agreements (MTAs).
• Maintain export control databases (eCOI+, RAPSS, and others) with accurate, up-to-date information.
• Log export determinations, license status, and screening results in compliance systems.
• Support internal compliance audits and generate reports for regulatory reviews.
• Work Hours: 40 hours per week; Contract Duration: 6 months (possible extension); initial 2 weeks on-site training in Piscataway, NJ, then 100% remote.

Export Compliance Analyst

• Provide staff support for preliminary assessments, inquiries, and investigations of alleged research misconduct.
• Coordinate meetings of inquiry committees and investigative panels.
• Facilitate forensic analyses of digital and physical evidence.
• Review and analyze case materials involving plagiarism, data falsification, or fabrication.
• Ensure proper confidential record retention in accordance with federal and institutional policies.
• Collaborate with the Office of General Counsel to prepare and submit required reports to federal agencies (e.g., ORI, NSF OIG).
• Draft official communications and summaries of investigative findings.
• Maintain secure and well-organized records for all misconduct cases.
• Support internal tracking systems for case progress, outcomes, and reporting metrics.
• Work remotely, supporting a clinical research academic university client; coordinate with cross-functional stakeholders.

Misconduct Investigations Analyst – Regulatory Affairs

• Report to the Export Control Manager and AVP for Regulatory Affairs and support client adherence to U.S. export control regulations.
• Conduct export control determinations for research projects, agreements, equipment, and material transfers.
• Perform restricted party screenings against U.S. government lists (e.g., BIS Entity List, OFAC SDN List) and log screening results.
• Identify compliance risks and escalate complex issues to the Export Control Manager.
• Assess license requirements and applicability of exceptions/exemptions under EAR, ITAR, and OFAC; assist in preparation, submission, and monitoring of export licenses and Technology Control Plans (TCPs).
• Determine commodity jurisdiction and classification for items, technology, and software; review and interpret export/import documentation.
• Support compliance reviews of Material Transfer Agreements (MTAs) and ensure ongoing compliance with license terms and conditions.
• Maintain export control databases (eCOI+, RAPSS, and others) with accurate information; log export determinations and license status.
• Support internal compliance audits and generate reports for regulatory reviews; ensure accurate documentation for transactions involving controlled materials, technology, and research.
• Work 40 hours per week on a 6-month contract (possible extension); 100% remote with EST zone work hours.

Regulatory Affairs – Export Compliance Analyst

Clinical Operations

Clinical Research Operations Assessment Specialist

Clinical Research

• Lead the engagement as SME for the current-state operational assessment across Technology, Organization, Process, People, and Finances, with focus on Non-Oncology programs.
• Conduct structured stakeholder interviews with clinical research staff and stakeholders across the trial lifecycle to identify gaps, bottlenecks, and opportunities for improvement in Non-Oncology operations.
• Collaborate with the Vitalief delivery team to design interview templates and assessment tools.
• Compare Oncology and Non-Oncology operations to surface transferable best practices.
• Develop prioritized, actionable recommendations to address immediate operational deficiencies while protecting long-term integration potential.
• Outline a clear transformation roadmap to achieve operational excellence and improved coordination across the system.
• Provide regular project status updates to executive stakeholders, ensuring alignment and on-time delivery of engagement milestones.
• Deliver a final executive-level presentation summarizing findings, recommendations, and measurable next steps.
• Engage in part-time 20 hours/week schedule and support on-site visit logistics as needed.