Vasomune Therapeutics, Inc., is a private clinical-stage therapeutic biopharmaceutical company developing the next generation of medicines to harness the body’s ability to defend against illness. Vasomune discovers and develops drugs using a unique therapeutic approach focused on normalizing the vasculature. Vasomune’s lead clinical candidate is a novel first-in-class Tie2 receptor agonist being developed for the treatment of hospitalized patients with pneumonia due to COVID-19 and/or other viral and bacterial infections at risk for or with Acute Respiratory Distress Syndrome (ARDS). Vasomune’s corporate headquarters and laboratories are located in Toronto, Canada with US offices in San Mateo, CA. For more information about the company and its product candidates, please visit www.vasomune.com.
Vasomune is a leading private clinical-stage therapeutic biotechnology company developing innovative mediations that address unmet medical need, with offices in Toronto, Canada and San Mateo, California.
We are hiring a Senior Clinical Research Associate (CRA) to join our Clinical Research Project Team (CRPT).
The Senior CRA will maintain oversight and manage the conduct and execution of clinical studies at Vasomune in compliance with company policies, as well as applicable regulatory requirements. This individual will be a key member of the Clinical Research Project Team (CRPT) responsible for monitoring clinical studies and working closely with other CRPT team members, external consultants and CROs to ensure efficient coordination and implementation of clinical trial activities. The person in this role will begin as a Senior CRA but, will have the opportunity to advance to a Clinical Manager position as Vasomune grows.
- Work with Project Manager in the development of study timelines and budgets per team and corporate goals;
- Ensure clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Vasomune SOPs;
- Participate in the identification, evaluation, qualification, selection, and oversight of clinical trial sites; partner efficiently, effectively, and professionally with participating study sites to ensure smooth study conduct; Implement strategic operational activities to ensure efficient study enrollment and high-quality monitoring activities at participating clinical sites;
- Review invoices and track study budget according to the forecast, working closely with clinical affairs, finance and project management;
- Manage multiple clinical study vendors with oversight of activities;
- Responsible for implementation and oversight of Trial Master File for inspection readiness;
- Participates in the development, review and sign-off of key study documents including clinical protocols, protocol amendments, consent forms, project plans, logs, templates, newsletter and clinical study reports, as needed;
- Provide study status updates and PROMPT reports to senior management;
- Lead ongoing study data reviews and data cleaning activities; Provide oversight of CRAs assigned to clinical trials and provide oversight of activities related to site qualification, initiation, interim monitoring, and close-out visits, as needed;
- Develop and deliver study training to investigators, site staff, and internal staff on select study processes;
- Develop processes and provide oversight of study supplies management;
- Participate in the preparation and follow-up of internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections;
- Conduct internal meetings for clinical trials;
- Conduct and participate in external meetings (e.g., Investigator Meetings), conferences and events;
- Participate in RFP and vendor selection process working closely with other members of the clinical research project team (CRPT);
- Train and mentor new clinical trial staff with appropriate delegation; may assume dotted-line management of team members;
- Escalate study issues/risks in a timely manner with solid communication skills;
- May develop SOPs and best practices and facilitate their implementation.
- B.A./B.S. degree with minimum 4 years of experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment;
- Strong leadership, effective decision making, and problem-solving skills required;
- Demonstrated knowledge of strategic clinical operations. Strong experience with clinical study conduct from start-up through close-out, with global trial and CRO management experience highly preferred;
- Infectious disease, ARDS or other acute care setting clinical experience desired;
- Working knowledge of relevant GCPs and FDA regulations; Independ self-starter with a tolerance of ambiguity that thrives in a fast-moving entrepreneurial environment;
- Experience operating in a small company semi-virtual matrix-based organization;
- Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables;
- Attention to detail and ability to prioritize tasks to meeting critical program deadlines;
- Team player with excellent written and oral communication skills;
- Proficiency with Microsoft Word, Excel and PowerPoint is required.
Working Conditions and Physical Requirements:
- May require occasional evening and weekend work;
- Full-time remote work with occasional travel to Company’s headquarters in Toronto, Ontario or in San Mateo, California;
- Up to 30% time traveling to clinical sites and clinical/professional meetings; may include international travel;
- Applicants must be currently authorized to work in the United States or Canada on a full-time basis;
- Opportunity to work remotely( i.e. from a location other than Ontario/California)