Senior Specialist, Study Start-Up Coordination and Regulatory Administration

Senior individual contributor across all sites and studies

Reports to: Director, Clinical Trial Business Operation
Direct reports: None
Administrative support: No assistant; this is a hands-on execution role

The opportunity and its scope

UniTope conducts industry-sponsored trials at investigator sites. This senior individual contributor leads the Administrative and Regulatory division across all sites and studies. Study startup coordination is a core responsibility: you personally complete regulatory startup deliverables and coordinate readiness for a timely Site Initiation Visit (SIV). After SIV, you retain study-level regulatory administration through closeout.

All studies use central IRBs, and sponsors handle most IRB submissions. This is not an investigator-initiated research or sponsor-side regulatory affairs position. It does not perform sponsor Trial Master File (TMF) work, develop sponsor regulatory strategy, or handle sponsor regulatory submissions. You maintain the Investigator Site File (ISF) and site regulatory binder.

This role does not find or solicit sponsors, secure studies, conduct feasibility assessments, or prepare, negotiate, or approve contracts or budgets. You obtain status updates from the responsible business owners and track their effect on the startup schedule.

What you will personally do

• Serve as the regulatory and administrative project coordinator during startup: maintain the plan, owners, deadlines, and dependencies; follow up across teams and escalate obstacles to timely SIV readiness.
• Personally complete regulatory startup checklists and site documents, coordinate sponsor requests and SIV scheduling, and track open activation requirements without making other teams’ readiness decisions.
• Handle verified study-level administrative communications with sponsors, CROs, and monitors; track requests and close the loop.
• Maintain accurate regulatory binders and ISFs; reconcile signatures, dates, versions, approvals, and site-specific requirements.
• Control protocols, amendments, manuals, and approved templates; distribute current versions and track required reviews and implementation evidence.
• Maintain training logs, PI-authorized delegation records, CVs, licenses, and credentials; personally pursue and resolve documentation gaps.
• Support sponsor-led central IRB processes and assigned site submissions; prepare regulatory monitoring records and maintain closeout and archive records.

Experience judgment and professional conduct

What you bring

• Extensive investigator-site experience in industry-sponsored trials, including regulatory startup and ongoing maintenance; ability to manage startup schedules, dependencies, and follow-up across teams without supervisory authority.
• Strong practical knowledge of GCP, central IRB workflows, ISFs, document control, training and delegation records, and electronic regulatory systems.
• Intellectual judgment: evaluate information critically, distinguish facts from assumptions, identify inconsistencies, and recognize when a decision exceeds your authority.
• Emotional intelligence: remain composed under pressure, listen carefully, communicate tactfully, and manage disagreement with discretion and professionalism.
• Organizational intelligence: understand reporting lines, decision rights, sensitive context, and when and how to involve the right leaders.
• Exceptional attention to detail, dependable follow-through, strict confidentiality, and consistently professional conduct in every interaction.

Authority and escalation

You work within a defined administrative remit. The Director of Compliance and Legal Affairs owns compliance interpretation and legal review. If you have any doubt about authority, accuracy, confidentiality, reporting obligations, or an appropriate response or action, promptly escalate to both the President of UniTope and the Compliance Director before responding substantively or proceeding. Keep your reporting director informed.

Communicate only verified information within your authority. Protect confidential information through approved systems and need-to-know sharing; do not speculate or make unauthorized commitments. Present concerns with concise facts, urgency, and a clear decision request, and follow through after direction is provided.

Working boundaries and success

The Director, Clinical Trial Clinical Operation leads participant-level operations, including eligibility coordination, dosing, source monitoring, and safety reporting. This role may assist with IRB submission mechanics when requested. Feasibility, contracts, budgets, RCM, recruitment, and marketing belong to other functions.

Success means timely regulatory startup deliverables and SIV coordination, accurate files, sound judgment, and fewer avoidable errors and follow-up demands on the President. This requires personally doing the detailed work without an assistant, while escalating concerns promptly. Multiple-site, oncology or theranostic experience and a relevant research certification are welcome.

Pay: $95,000.00 - $110,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• How many years of experience do you have coordinating clinical trial study start-up activities?
• Have you maintained and tracked study start-up timelines and milestones across multiple sites or studies to ensure sites are activated on schedule?
• Briefly describe your experience coordinating study start-up, including site readiness, SIV preparation, regulatory submissions, or tracking start-up timelines.
• What is your desired salary range for this position?

Work Location: In person

Salary : $95,000 - $110,000