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Project management·Project management & clinical coordination

The arm OCR was built on.

Before research development, AI tools, and strategic partnerships, our core work was helping investigators move clinical and translational research from idea to execution — building the infrastructure, regulatory scaffolding, and day-to-day coordination that human subjects research actually requires.

29
Active programs & projects in 2025
3
Connected areas of support
5
Team members on the bench
Project management·Origin

Bridging a gap
the field created.

01The shift

Basic science went to the clinic.

More basic and translational researchers are now pursuing human subjects work — but not every investigator has the clinical connections, clinic access, or experience navigating the regulatory and operational requirements that make these studies possible.

02The gap

Good science needs more than a question.

Human subjects research demands the right clinical partners, a feasible protocol, IRB approval, biospecimen and data workflows, participant-facing coordination, regulatory documentation, and ongoing project oversight.

03The response

OCR builds the infrastructure.

Our team supports projects from the earliest planning stages through active execution — serving as the connective tissue between the research lab, clinical collaborators, regulatory offices, and operational teams.

Project management·Three connected areas

One arm,
three points of entry.

Most programs draw on more than one. We tailor support to the study, not the other way around.

Biospecimen Pipelines01

From clinic to bench, sample by sample.

Design and operation of sample-collection workflows that connect clinical settings to research labs — consent, processing, chain-of-custody, banking, and downstream assay hand-offs.

  • Biospecimen pipeline design
  • Protocol consultation & IRB submission
  • Database development & QC/QA
  • Project launch & coordination
Clinical Studies & Trials02

Investigator-initiated and industry-sponsored.

Full-spectrum support for clinical studies and clinical trials, from activation through monitoring — meeting investigators wherever they are in the lifecycle of the study.

  • OCTA activation
  • Budget development & negotiation
  • Contract coordination & study startup
  • Clinical coordination & monitoring
Clinical Research Operations03

Supervising and standing up CRUs.

With experienced senior Clinical Research Coordinators on the team, OCR provides operational leadership, staff supervision, and workflow standardization for groups that need additional structure or capacity.

  • CRU operational leadership
  • Staff supervision
  • Workflow standardization
  • Hands-on capacity support
Project management·Current portfolio

29 active programs
and projects in 2025.

  • →Total volume has grown steadily each year, reflecting strong expansion across all support areas.
  • →We're operating at near-full bandwidth; further growth would require new hires, space, and management overhead.
  • →The current Project Management surge (18 in 2025) reflects CoProjects, which is expected to wind down within 1–2 years.
Active programs & projects by area
2023
2024
2025
1
2
2
Program Management
2
9
18
Project Management
4
11
15
Clinical Coordination
3
4
13
Data Management
Project management·Clinical coordination model

Three ways
we deploy CRCs.

Our coordination model flexes with the science. The same team takes on three distinct shapes depending on what the study needs.

  1. Niche 01

    OCR as a flexible CRU for non-clinical researchers

    Acts as an on-demand Clinical Research Unit for groups without a dedicated one — guiding investigators new to human-subjects work through regulatory and procedural requirements.

    In practice
    • Sjögren's Clinic
    • Lupus Nephritis at UCSF & ZSFG
    • Prostate Cancer Program
  2. Niche 02

    OCR partners with existing CRUs to extend capacity

    Shares CRCs with established CRUs whose bandwidth is consumed by clinical trials, ensuring non-clinical projects still get timely, adequate coordination.

    In practice
    • Gastrointestinal Oncology
    • Brain Tumor Center
  3. Niche 03

    OCR embeds CRCs within departments or institutions

    Places CRCs strategically inside specific institutions or departments to act as an honest broker — supporting research across multiple divisions and bridging clinical groups.

    In practice
    • St. Mary's & St. Francis Hospitals
    • ZSFG
Project management·Specimen & data pipelines

Every sample — and
every data point — accounted for.

From the clinic to the assay, our lifecycle keeps science moving and provenance intact. Alongside every specimen runs a data pipeline we build and maintain with the same care.

Biospecimen flow
  1. 01
    Collect

    Consent + SOP-driven sample collection at the site.

  2. 02
    Process

    Centrifuge, aliquot, label — chain-of-custody logged.

  3. 03
    Bank

    Biorepository integration: barcoded, temperature-monitored.

  4. 04
    Ship

    Manifested, IATA-compliant shipping to downstream cores.

  5. 05
    Assay

    Hand-off to single-cell, proteomics, sequencing partners.

Data flowBuilt with OCR data management
  1. 01
    Collect

    Clinical and sample metadata captured at the source, in REDCap or the study database.

  2. 02
    De-identify

    PHI stripped or coded under the IRB-approved plan before anything leaves the clinic.

  3. 03
    Upload

    Secure transfer to the study's data environment — logged, versioned, and access-controlled.

  4. 04
    Store

    Structured, backed-up storage linked to the specimen record by a shared ID.

  5. 05
    QC & curate

    Range checks, missingness reports, and harmonized variables — in partnership with OCR data management.

  6. 06
    QA

    Periodic audits against source so the dataset is ready for analysis and sharing.

Project management·In motion

Two partnerships
shaping what's next.

Pilot · UCSF Health

OCR & St. Mary's / St. Francis Hospitals

UCSF Health acquired St. Mary's and St. Francis earlier in the year. With Ted Abraham leading affiliate networks, OCR is piloting an on-site CRC for three years to broaden the clinical research portfolio — acting as an honest broker across community physicians and multiple departments.

  • 3-year on-site CRC pilot
  • Expanding industry-sponsored & registry portfolio (~11 protocols today)
  • Possible extension to MarinHealth, Sonoma Valley, John Muir, Washington Hospital
Program · with ImmunoX

New Biospecimen Pipeline Development

A funded award that helps researchers establish or improve pipelines for obtaining human biospecimens from clinical settings — allocating up to 50% of an OCR CRC's effort for study setup, participant recruitment, consent, sample acquisition, and data management.

2024 awarded applications
  • Chronic Rhinosinusitis
    Airway Brushings · Kotas
  • Immune Development
    Pediatric Tissues · Crouch
  • Brain Metastasis
    Brain Tumors · Young
  • Prostate Cancer
    Prostate Tumors · Bose
  • Tuberculosis
    Tissue Biopsies · Sithole
Project management·The bench

Five people.
Fractional, flexible, shared.

Project Managers and CRCs contribute fractional effort across multiple studies — making high-quality clinical research support accessible to investigators who don't need (or can't fund) a full-time hire.

Role
On bench
Focus
Project Manager
1
Cross-program oversight & study setup
Senior Clinical Research Coordinator
3
Translational & clinical trial leads
Clinical Research Coordinator
1
Participant-facing coordination & sample workflows
Project management·In their words

From the investigators
we run studies with.

“OCR gave us the connective tissue between our lab, the clinic, and the regulatory office. Our study would not have launched without them.”
— Principal Investigator, Translational Research
“We didn't need a full-time coordinator — we needed the right twenty percent of one. OCR made that possible.”
— PI, Investigator-Initiated Study
“Their senior CRCs brought structure to a group that had been improvising for years. The standardization was immediate.”
— Division Chief, UCSF Health
Run with us

Have a study that needs
a steady hand?

Tell us where you are — pre-award, in startup, or mid-flight — and we'll show you exactly where our team can plug in.