Alliance Clinical Network — Regulatory Coordinator & QC Team Scaling | One CoreDev IT®
Confidential — Pre-Meeting Brief

Alliance Clinical Network:
Regulatory Coordinator Placement & QC Team Scaling

This brief covers two aligned opportunities: an immediate Regulatory Coordinator placement CORE has already sourced candidates for, and the strategic case for rebuilding Alliance's Manila QC team at scale. Both are ready to move.


Prepared forJosh Petersen, VP Quality & ControlCheree, Director — Regulatory Affairs & Quality Control
FromJonathan Miller, CEORaine Villarama, Operations Manager, Business Partnerships
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CORE has delivered this for Alliance before — at scale. At its peak, CORE managed 19 QC team members for Alliance across Phases I through III of active site operations. This is not an introduction to a new vendor. It is a proposal to rebuild a proven model with a deliberate growth roadmap aligned to where Alliance is heading.

Regulatory Coordinator: candidates are sourced and ready

CORE has pre-screened a shortlist of four candidates for the Regulatory Coordinator role Cheree has been prioritizing. Two are mid-level, two are senior. All have direct regulatory documentation and clinical trial experience. Alliance can review, select, and move to onboarding within 3 to 5 weeks from a go-decision.

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Mid-Level Profiles (x2)

Clinical Research Coordinator and CRA backgrounds with ICH-GCP certification, EDC platform experience (Medidata Rave, CRIO eReg), regulatory documentation, and TMF management. One carries a PhD in Genetics with direct US-based remote trial coordination experience at Arizona Liver Health. The other holds RN credentials with a PPD eTMF background spanning nearly four years.

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Senior Profiles (x2)

Senior CRA and clinical operations leadership backgrounds with Phase II through III global trial experience, FDA inspection support with zero critical findings, risk-based monitoring, and CAPA governance. One carries 15-plus years across IQVIA, PPD, and ICON plc. The other has managed multi-country clinical operations at Fortrea, Novotech, and GlaxoSmithKline, and holds a pharmacy license.

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This role does not require the QC rebuild conversation to proceed. CORE can engage Cheree on the Regulatory Coordinator independently, present the shortlist for her review, and move to placement on a standalone basis. The QC rebuild is the strategic roadmap. The Regulatory Coordinator is the immediate next step — and the profiles are already in hand.
4
Pre-screened candidates ready for Cheree's review
3–5 wks
From selection to team member go-live
~60%
Cost reduction versus a comparable US-based hire
Mid & Sr.
Two seniority tiers available — Cheree selects the fit

Onshore QC cannot scale as fast as your office footprint

Alliance's active QC job postings point to a pattern that most growing site networks eventually run into: the US clinical research labor market struggles to fill experienced QC roles fast enough, and even successful hires don't stay long. The combination of rapid site expansion and high onshore attrition creates a compounding capacity problem that traditional recruiting alone cannot solve.

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The attrition data is unambiguous. Studies on site-based clinical research staff — nurses and coordinators — show annual turnover of 35 to 61 percent in the US, with some programs approaching 100 percent. Each departure costs 1.5 to 2x annual salary in backfill, retraining, and lost institutional knowledge. For a 15-person onshore QC team, that is a recurring six-figure loss every year.
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Open QC postings signal a scaling gap, not a hiring backlog

The roles Alliance is advertising reflect demand that grows with each new office. Traditional recruiting timelines of 60 to 90 days per US hire cannot keep pace with that trajectory.

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Attrition erodes the team you already built

Experienced QC staff who leave take protocol familiarity and site-specific knowledge with them. Offshore teams managed by CORE average under 10% annual attrition — a structural advantage, not just a cost one.

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Each new Alliance office creates immediate QC demand

Every site expansion adds document volume, query management, and phase-specific review load. A Manila team scales to each new office without triggering a new domestic recruiting cycle.

payments

Fully-loaded US QC hires run $75K–$105K per seat

Add turnover risk and the cost compounds year over year. The offshore equivalent through CORE's managed services model runs $28K to $42K annually with all HR, compliance, and infrastructure included.

The site network market is growing. QC demand grows with it.

Alliance's expansion is following a durable industry trend. The context below matters for the Josh and Cheree discussion — and for what Anthony and Jason will ask when this goes up the org.

$4.5B
Projected US clinical trial site network market by 2030 (up from $2.88B in 2024)
7.7%
Annual CAGR driven by trial complexity, chronic disease volume, and specialized site demand
35–61%
Annual US turnover range for site-based clinical research staff per published industry studies
<10%
Attrition on mature managed offshore teams per McKinsey research on offshore operations
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What peer organizations are doing: The largest US site networks and CROs are building centralized offshore QC and clinical operations functions in the Philippines — specifically to handle document-based review, query management, and phase coordination work that does not require physical site presence. CORE is already operating in this space. Alliance has the advantage of a proven model to rebuild from.

The Philippines produces deep clinical talent — well beyond nursing

This is not a generalist offshore labor conversation. The Philippines has a broad, credentialed healthcare workforce spanning multiple licensed disciplines — RNs, pharmacists, medical technologists, biologists, clinical research coordinators, and pharmacovigilance specialists — actively placed in clinical research roles for US clients. For Alliance, that depth means CORE can staff across your QC function without compromising on credential level or clinical relevance.

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Phase I – III
QC Specialist (RN-Level)

Active Philippine nursing license. Clinical research background. ICH-GCP certified. Experienced with Medidata, Veeva Vault, and EDC platforms. Performs document-based QC review across trial records — source document verification, protocol adherence, data integrity, and regulatory compliance.

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Pharmacy / Clinical Trial Supply
Licensed Pharmacist

Philippine-licensed pharmacists with clinical research experience supporting investigational product accountability, drug dispensing documentation, protocol-defined dosing compliance, and pharmacy log maintenance. Particularly relevant for Phase I and II trials with complex IMP management requirements.

biotech
Laboratory & Diagnostics
Medical Technologist

Licensed Philippine medical technologists supporting lab data review, specimen processing documentation, reference range validation, and central lab reconciliation. Strong familiarity with clinical laboratory standards and GCP-compliant data handling for trial endpoints.

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Life Sciences
Biologist / Life Sciences Specialist

Biology-degreed professionals supporting protocol review, scientific data abstraction, case narrative drafting, and literature-based background research. Useful for oncology, immunology, and biologics trials where scientific depth in document review adds material value to QC output.

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Documentation & Admin
QC Coordinator / Study Admin / EC & Study Admin

Manages trial documentation workflows, tracks query resolution timelines, coordinates with site staff on outstanding items, and maintains TMF compliance and regulatory binders. Directly analogous to roles Alliance has previously used in the Manila team.

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Leadership
Offshore QC Team Lead

Supervises the Manila QC team, manages daily output against KPIs, serves as primary liaison with onshore QC management, and owns performance documentation. Reduces Josh's management overhead significantly as headcount scales.

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Safety & Pharmacovigilance
Drug Safety / PV Associate

Adverse event documentation, SAE reporting, safety database management, MedDRA coding under physician supervision. Philippine PV professionals are actively placed in US and global clinical research roles at scale.

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CORE's clinical talent pipeline spans multiple licensed disciplines. We maintain pre-screened candidate pools for RNs, licensed pharmacists, medical technologists, biologists, CRCs, and clinical operations roles in Makati. This breadth means Alliance is not limited to a single credential type as QC scope evolves across new offices and therapeutic areas. Placement timelines run 3 to 5 weeks from engagement start — not 60 to 90 days.

What the numbers look like for Anthony and Jason

CORE operates Alliance's team under a managed services model: all-in hourly rate, one vendor relationship. Alliance directs the work. CORE covers employment, HR, benefits, office, equipment, and Philippine statutory compliance. One rate. No hidden obligations on Alliance's books.

Role US Fully-Loaded Annual Cost CORE Managed Services (Est. Annual) Annual Savings Per Seat
Regulatory Coordinator (Mid) $65,000 – $80,000 $24,000 – $30,000 ~$40,000 – $52,000
Regulatory Coordinator (Senior) $85,000 – $105,000 $32,000 – $40,000 ~$52,000 – $68,000
QC Specialist (RN-Level) $85,000 – $105,000 $30,000 – $38,000 ~$55,000 – $67,000
QC Coordinator / Study Admin $60,000 – $75,000 $22,000 – $28,000 ~$40,000 – $50,000
Offshore QC Team Lead $100,000 – $120,000 $36,000 – $46,000 ~$60,000 – $80,000
Drug Safety / PV Associate $70,000 – $90,000 $26,000 – $34,000 ~$44,000 – $60,000
$500K+
Annual savings at 10 QC specialists
$1M+
Annual savings at 19-person team — Alliance's prior scale with CORE
<10%
Offshore attrition vs. 35–61% for US clinical research staff
1.5–2x
Annual salary cost of each US QC departure (backfill + retraining)

The attrition savings compound the cost argument.

At 35% annual turnover on a 15-person US QC team averaging $85K salary, Alliance absorbs $445,000 to $595,000 per year in turnover costs alone — before accounting for productivity loss during vacancy. The offshore model eliminates that exposure structurally, not just financially.

$1M+ Annual savings at prior team scale

What CORE manages so Alliance doesn't have to

Alliance directs the work. CORE owns the employment relationship, the HR function, the physical office infrastructure, and all compliance obligations on the Philippines side.

check_circlePhilippine labor law compliance and statutory contributions (SSS, PhilHealth, Pag-IBIG)
check_circle13th month pay, statutory leave, and all mandated benefits
check_circlePayroll processing and tax withholding — no involvement from Alliance's finance team
check_circleDay-to-day HR: performance documentation, disciplinary process, separation management
check_circleOffice infrastructure at The Peak Tower, Makati City — secure, equipped, professionally managed
check_circleHIPAA compliance training before any PHI is accessed — BAAs executed at engagement start
check_circleBackfill management: if a team member exits, CORE initiates replacement immediately
check_circleActive talent pipeline — pre-screened candidates, 3–5 week placement timeline
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Alliance's prior model with CORE worked because of this structure. At 19 team members supporting Phases I through III, Cheree managed the Manila team directly as an extension of Alliance's QC function — not a separate vendor layer. That direct management relationship, and the skills development culture Cheree has built, is what CORE proposes to rebuild and scale.

From decision to operational in 4 to 6 weeks

CORE maintains active candidate pools for clinical research roles. We are not starting from zero. The timeline below reflects a typical engagement from initial scoping to go-live.

1
Scoping Call — Week 1

Define role profiles, phase requirements, volume targets, EDC systems, and documentation standards. Align on KPIs and the reporting structure between Manila and Alliance's US QC management team.

2
Candidate Presentation — Week 1 to 2

CORE presents pre-screened candidates with verified clinical research backgrounds. Alliance reviews and approves. No placement without your sign-off.

3
Onboarding & Compliance Certification — Week 2 to 4

Team members complete your workflow training, EDC system orientation, and HIPAA compliance certification before handling live trial data. CORE manages the logistics. Alliance controls the content.

4
Go Live — Week 4 to 6

Manila QC team is operational and producing output against Alliance's KPIs. Initial performance review at 30 days. CORE manages ongoing HR, backfill, and compliance renewals from this point forward.

What we would like to cover on our call

This brief covers both the immediate Regulatory Coordinator placement and the broader QC team rebuild. The agenda below is what we would like to cover on our call so we can focus the time on specifics rather than background.

Agenda for our introductory discussion

1
Regulatory Coordinator placement (immediate) — CORE has four pre-screened candidates ready for Cheree's review across mid and senior levels. We will walk through the shortlist, confirm the profile fit, and align on next steps. This role can move to onboarding within 3 to 5 weeks from a go-decision.
2
Alliance's office expansion roadmap — how many new sites in the next 12 to 18 months, and what QC headcount each site requires.
3
Current QC team composition — onshore headcount, open roles, and where capacity pressure is most acute across phases.
4
Role-by-role scoping — which functions map most directly to offshore delivery: document review, query management, TMF maintenance, study admin, or PV support.
5
The rebuild proposal — CORE will prepare a specific headcount model with all-in managed services rate, projected savings, and deployment timeline for Anthony and Jason's review.
6
Cheree's continued leadership of the offshore team — as Director of Regulatory Affairs & Quality Control, Cheree has been the consistent anchor of the Manila team's performance. She manages the team directly, sets the standards, and has been instrumental in creating a skills development environment where offshore team members grow their QA and compliance capabilities over time. That continuity is a core part of what CORE brings to Alliance.
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