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Edgewise Therapeutics · 1 month ago

Senior Clinical Research Associate - Cardiovascular (EDG-2025017)

Boulder, CO

Full-time

Hybrid

Mid, Senior Level

$100K/yr - $140K/yr

4+ years exp

Edgewise Therapeutics is on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. They are seeking a Senior Clinical Research Associate to lead site start-up activities, collaborate with internal teams, and ensure the successful execution of complex clinical trials.

BiopharmaBiotechnologyHealth Care

Responsibilities

Lead site start-up activities (e.g. oversight of CRO start-up activities, accountable for essential document package review, site initiation slide deck, vendor training, participate in remote/or on-site initiation visits) and contribute to feasibility, as required

Collaborate with contracts team to lead review and negotiation of site and vendor budgets/contracts

Contribute to the development and review of study, patient and site facing documents (e.g. protocols, ICFs and study plans)

Oversee Edgewise contract CRA and/or CRO monitoring activities (e.g. visit schedules, monitoring visit reviews, monitoring plan review). May include on-site co-monitoring with CRO CRA, ensuring compliance with protocol and regulatory requirements. Provide additional clinical monitoring training support to CRO personnel, as needed. Attend CRO monitoring meetings. May include assigned monitoring responsibilities for sites

Review and oversee site KPIs, protocol deviations and metrics to identify trends and maintain data quality. Escalate site level risks or non-compliance, and in collaboration with Quality Assurance, review Site Corrective and Action Plans (SCAPAs), Corrective and Action Plans (CAPAs) and Site Audits

Support the Edgewise clinical study lead in managing progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment and other tasks as assigned

Proactively review electronic data capture (EDC) for completion and to identify issues and generate queries. Identify and monitor risks and decisions at the study level and implementation of mitigation strategies. Identify potential operational challenges, and in collaboration with senior team members, provide guidance and solutions to ensure study execution remains on track

Contribute to drafting Standard Operating Procedures (SOPs) and adhere to Clinical Operations processes and SOPs to ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and attending the inspections

Responsible for the oversight of assigned vendors

Collaborate with internal teams (e.g. Clinical Operations, Regulatory Affairs, Data Management, Medical Monitoring, CMC, etc) to ensure seamless trial execution and provide regular study updates to the appropriate internal stakeholders

May be accountable for reviewing site or vendor invoicing and financial management in accordance with the clinical trial agreement / scope of work

Support TMF activities as required (e.g. review of TMF index, document provision, etc.)

Support onboarding and mentoring of new department members

Qualification

Clinical operations experienceOn-site monitoring experienceCardiac study experienceFDA knowledgeICH Guidelines knowledgeGCP knowledgeMS Office proficiencySmart Sheet proficiencyAttention to detailInterpersonal skillsPresentation skillsTeam player

Required

At least 4+ years of relevant clinical operations experience and a BS or BA (Life Sciences)

Minimum 4 years of independent on-site monitoring experience (across all visit types and inclusive of remote monitoring), with at least 3 years cardiac study experience in a pharmaceutical sponsor environment preferred (global pharma or biotech preferred)

Excellent attention to detail, verbal, written, interpersonal and presentation skills are required

Must be familiar with routine medical/scientific terminology

Proficiency with MS Office required (inclusive of PPT); Smart Sheet proficiency desirable

Knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials is required

Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision

Highly productive, engaged and accountable

Team-player desiring to work in a fast-moving, dynamic start-up environment