Clinical Research Associate (II-SCRA) (Central)

Novotech Global•South San Francisco, CA

2d•$70,000 - $140,000

About The Position

The Clinical Research Associate (CRA) protects trial participants’ rights and wellbeing and ensures trial data are accurate, complete, and verifiable against source documents. The CRA serves as the primary contact among investigational sites, Novotech, and the sponsor, and manages site relationships to help ensure trials comply with ICH GCP guidelines, applicable local and global regulatory requirements, and Novotech and client SOPs. The role involves coordinating and monitoring clinical trial sites across all phases of a study, supporting site start-up and regulatory processes, promoting participant recruitment, overseeing participant safety, data quality, and study-drug accountability, and maintaining study documentation and systems. The CRA also communicates site progress and issues to the project team, supports audit and inspection readiness, and assists with project planning and site payments.

Requirements

Graduate qualification in a clinical or life sciences-related field; relevant experience or qualifications in allied professions may also be considered.
Good time-management skills.
Attention to detail.
Ability to work well in a team.
Computer literacy.
CRA II: approximately 1–2 years of Clinical Research Associate experience, or equivalent experience in another clinical-industry role for the CRA II fast track.
The description also specifies experience by job level: CRA III requires at least 2–3 years of Clinical Research Associate experience, and Senior CRA requires at least 3–5 years.

Nice To Haves

Experience in research, the pharmaceutical industry, or a related field, with the preferred level depending on the job level.

Responsibilities

Build relationships with principal investigators, study coordinators, pharmacists, and other site trial personnel to support efficient clinical-trial management.
Foster internal and external customer relationships to support efficient, timely, and productive project delivery.
Collaborate with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA) to prepare essential site documents and support ethics and regulatory submissions and approvals.
Work with the Regulatory Start-up team to understand applicable local and international regulatory requirements.
Support participant recruitment against site targets, lead site recruitment and engagement initiatives, and prepare and update site-specific recruitment plans.
Monitor investigational sites according to ICH GCP §5.18 and each study’s Clinical Monitoring Plan, including site selection, initiation, monitoring, and close-out visits, unblinded pharmacy visits, and co-monitoring visits; visits may be onsite or remote as specified in the plan.
Protect participants’ rights and wellbeing by checking consent forms and eligibility, monitoring protocol and investigational-drug compliance, reviewing adverse events and serious adverse events, and promptly reporting safety issues to the sponsor.
Verify trial data for accuracy and completeness, and ensure CRF data and queries are completed and resolved within study timelines.
Ensure study drug is stored, dispensed, accounted for, and reconciled according to the Clinical Monitoring Plan and protocol.
Collaborate with the IHCRA or DMA team to keep the Trial Master File current and complete throughout the study.
Support sites in maintaining audit and inspection readiness.
Keep clinical trial management systems current with relevant trial data.
Provide written and verbal site progress updates, including monitoring visit reports, to the PM/LCRA according to study timelines and applicable plans and SOPs; escalate key issues according to the Issue Escalation SOP.
Collaborate with the IHCRA and Site Contract Associates, as applicable, on site payments, and take ultimate responsibility for ensuring payments are executed according to the Clinical Trial Agreement.
Assist the PM with developing study project plans and templates and support other tasks needed for successful study execution.