Job Description

Summary:

Our client is a clinical-stage biotechnology company focused on building the

leading, fully integrated platform for precision genetic medicines. Their approach centers

on developing and refining gene editing and delivery technologies to create effective,

safe treatments. At the core of their work is homology directed repair (HDR), a

proprietary method that allows us to make precise, predictable, and efficient changes to

specific DNA sequences.

By leveraging natural repair processes evolved over time, they maximize safety and

accuracy, enabling a broad range of therapeutic strategies. This foundation supports

their diverse portfolio of HDR-based programs aimed at delivering life-long cures for

serious diseases.

Their first clinical trial, is now approaching Phase II with a novel technology treating

Severe Sickle Cell Disease. Based on Phase 1 data from our first- and best-in-class

true gene correction, they anticipate momentum in the clinical trial with feedback from

FDA on our path towards regulatory approval.

Role:

A high-caliber and detail-oriented Clinical Research Associate (CRA) to

support the execution of the NEW clinical trial, a core clinical program advancing

the company's autologous gene therapy. This is a critical role within our growing

Clinical Operations organization.

As a CRA, you will be responsible for making sure clinical trial sites operate in full

compliance with protocol requirements, regulatory standards, and company's

quality expectations, while maintaining the highest standards of patient safety and data

integrity.

This role is designed for a proactive operator who excels in the operational complexities

associated with advanced therapeutic modalities. The ideal candidate thrives in a fast-

paced startup environment where precision, strong site partnerships, and early

identification of operational risks are essential to successful trial execution.

By overseeing day-to-day site monitoring activities, maintaining inspection-ready

documentation, monitor and verify site compliance with chain-of-identity (COI) and

chain-of-custody (COC) procedures associated with the autologous gene therapy

workflow, and promptly escalate deviations, the CRA plays a vital role in supporting the

successful execution of the NEW study.

Through disciplined site oversight and data quality management, this role enables the

clinical team to generate reliable data and advance company's clinical development

efforts.

Key Responsibilities:

Site Monitoring & Oversight:

o Conduct site qualification, initiation, monitoring (on‑site and remote), and

close‑out visits per the monitoring plan and risk‑based monitoring approach.

o Ensure compliance with protocol, ICH‑GCP, regulatory requirements, and

company SOPs.

o Perform source data review/verification and ensure documentation supports

clinical endpoints.

o Monitor site performance metrics and drive corrective actions with the Clinical

Trial Manager.

Participant Protection & Informed Consent:

o Verify informed consent is properly obtained and documented.

o Ensure ongoing compliance with updated consent forms and protocol

amendments.

o Confirm participant rights, safety, and confidentiality are maintained.

Autologous Gene Therapy Execution (COI/COC):

o Monitor adherence to chain‑of‑identity and chain‑of‑custody processes.

o Oversee compliance with apheresis/cell collection workflows and shipment

procedures.

o Ensure proper handling of temperature‑controlled and cryogenic shipments.

o Coordinate with manufacturing, logistics, and supply chain teams to align

collection and infusion schedules.

Investigational Product &; Materials Accountability:

o Ensure accurate accountability of investigational materials and ancillary

supplies.

o Verify storage conditions, temperature logs, and excursion management.

o Confirm documentation of product receipt, reconciliation, and

return/destruction where applicable.

Data Quality & Systems:

o Review EDC entries for completeness and accuracy.

o Resolve queries with sites and data management.

o Ensure timely and accurate safety reporting including SAEs.

Documentation & Inspection Readiness:

o Ensure investigator site files and trial master file documentation are complete

and inspection ready.

o Maintain accurate monitoring reports and follow‑up documentation.

o Support audit and regulatory inspection readiness activities.

Site Relationship Management & Training:

o Serve as the primary monitoring contact for assigned clinical sites.

o Provide training on protocol procedures, amendments, and operational

workflows.

o Build strong working relationships while maintaining compliance standards.

Qualifications:

Education:

o Bachelor’s degree in life sciences, nursing, pharmacy, or related field

required. Advanced degree preferred.

Experience:

o 3+ years of clinical monitoring experience in biotech, pharma, or CRO

environments.

o Experience with cell therapy, gene therapy, oncology, or rare disease trials

preferred.

o Experience coordinating complex clinical logistics or centralized

manufacturing models is a plus.

The right candidate will have:

o Strong understanding of ICH‑GCP and regulatory requirements.

o Experience with EDC, CTMS, and electronic Trial Master File systems.

o Strong organizational skills and attention to detail.

o Ability to collaborate effectively across clinical, regulatory, manufacturing, and

supply chain teams.

Compensation:

The expected base salary range for this position is commensurate with experience and qualifications. Our client offers highly competitive equity participation, a performance-based incentive program, and a comprehensive benefits package designed to support employee well-being and professional growth.

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