Clinical research support for AMCs & Cancer Centers

Academic Medical Centers, Cancer Centers & Research Hospitals

Your teams are stretched thin, activation backlogs are growing, and high-priority trials need to open yesterday. We have sat in your chair.

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Your Challenges

What slows you down, and what we do about it

Study activation takes months: Startup and activation support, from essential documents through IRB/EC and ancillary committee approvals, with milestone tracking and escalation.
Backlogged budgets, contracts, and regulatory submissions: Senior startup and regulatory coordinators who clear the queue and keep the dependencies between Finance, Legal, and the IRB moving.
Coordinator and regulatory staff turnover: CRC and regulatory coordinator backfill with a documented handover, so studies do not stall when someone leaves.
Staff on leave with no coverage plan: Time-boxed coverage from our Coverage & Backfill package: a vetted professional for the leave period, then a clean handback.
Investigator-initiated trials without IND or GCP infrastructure: IND documentation, annual reports, and GCP guidance for sponsor-investigators.
Inspection anxiety before an audit: Inspection Readiness Review: a gap assessment of regulatory files and investigator site files, with a remediation plan.
Pressure to open more industry-sponsored trials: Activation Cycle-Time Assessment, SOPs, and training that make startup faster and more predictable across the portfolio.

Roles We Place

Professionals who fit AMCs & Cancer Centers

Study Start-Up Specialist

Gets trial sites ready to enroll patients. Collects and reviews essential documents, prepares IRB/EC submissions, tracks approvals, and coordinates with sites so each one opens on time and in compliance with Good Clinical Practice (GCP).

Study Start-Up Manager

Leads the full startup process for one or more studies, from site selection through activation. Sets timelines, manages the startup team, removes contract, budget, and regulatory roadblocks, and reports progress to leadership.

Regulatory Coordinator

Prepares and maintains IRB submissions, regulatory binders, and essential documents at the research site.

Clinical Research Coordinator (CRC)

Runs the study at the hospital or clinic: recruits and consents patients, schedules visits, collects data, and acts as the link between patients, doctors, and the sponsor.

Site Contracts & Budget Specialist

Negotiates clinical trial agreements and budgets between sponsors and sites. Delays here are one of the most common reasons trials open late.

Regulatory Affairs Specialist

Handles communication and paperwork with regulators such as the FDA. Prepares and submits applications (such as an IND), amendments, and annual reports, and keeps the trial compliant from start to finish.

See all roles we place

Fixed-Scope Packages