Senior Clinical Research Associate - Cardiovascular

Senior Clinical Research Associate - Cardiovascular

At Edgewise Therapeutics, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders. We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!

About the Position

Edgewise is headquartered in Boulder, Colorado; this is a position for a growing Colorado-based Clinical Development team. The assigned clinical trials will be highly complex and high risk, e.g. multiple indications, data monitoring committees, interim analyses, adaptive design, requiring the coordination of multiple vendors, or other special assessments. Candidates may be asked to provide support to the Edgewise clinical study lead for more than one study or across programs.

Key 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.

Required Education, Experience, Skills

• 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

This is a full-time position (40 hours/week), hybrid, Colorado based preferred. 20-50% travel. Salary range: $90,000 - $140,000, title and salary commensurate with experience

Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan. There is no deadline because the employer accepts applications on an ongoing basis.