Clinical Research Associate (II-SCRA) (Southeast)

Novotech Global•South San Francisco, CA

2d•$70,000 - $140,000

About The Position

The Clinical Research Associate (II-SCRA) builds relationships with Principal Investigators, study coordinators, pharmacists, and other site personnel to support efficient clinical-trial management and delivery. The role works with internal teams and external customers to meet study requirements and timelines, supports site documentation and ethics and regulatory submissions, and helps sites meet recruitment targets. The position monitors investigational sites in accordance with ICH GCP §5.18, the Clinical Monitoring Plan, applicable regulations, and study procedures. Monitoring activities span site selection, initiation, monitoring, and closeout, including unblinded pharmacy and co-monitoring visits; visits may be onsite or remote as specified by the plan. The CRA safeguards participant rights and wellbeing, verifies data and investigational product management, maintains study records and systems, supports audit readiness, and provides progress updates and escalation of issues. The role also collaborates on site payments and assists the Project Manager with study plans, templates, and other execution tasks.

Requirements

Graduate in a clinical or life sciences-related field; relevant experience or qualifications in allied professions may also be considered.
Good time-management skills and attention to detail.
Ability to work well in a team.
Computer literacy.
For 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.

Nice To Haves

Experience working in research, the pharmaceutical industry, or a related field.
For CRA III: at least 2–3 years of Clinical Research Associate experience in the clinical industry.
The posting also lists a CRA III qualification of at least 4+ years of Clinical Research Associate experience in the clinical industry.

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 timely and productive project delivery in line with study requirements and timelines.
Collaborate with the IHCRA and 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.
Drive site recruitment and engagement, ensure recruitment targets are pursued, and prepare and update site-specific recruitment plans.
Monitor investigational sites in accordance with ICH GCP §5.18, the Clinical Monitoring Plan, and applicable study requirements. Monitoring includes site selection, initiation, monitoring, and closeout visits, unblinded pharmacy visits, and co-monitoring visits, onsite or remotely as specified by the plan.
Protect trial participants’ rights and wellbeing by checking consent, confirming eligibility and protocol compliance, reviewing investigational drug compliance and adverse events/SAEs, 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 Clinical Monitoring Plan timelines.
Ensure study drug is stored, dispensed, accounted for, and reconciled in accordance with the Clinical Monitoring Plan and protocol.
Collaborate with the IHCRA or DMA team to keep the project 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 study progress updates, including monitoring visit reports, to the PM/LCRA according to study requirements, timelines, and applicable SOPs; escalate key issues in accordance with the Issue Escalation SOP.
Collaborate with the IHCRA and Site Contract Associates, as applicable, on site payments and take ultimate responsibility for ensuring payment execution according to the Clinical Trial Agreement.
Assist the PM with study-related project plans and templates and support tasks needed for successful study execution.