Sr. Clinical Research Associate
Location: Redwood City, CA
- Rezolute is a clinical stage biopharmaceutical company dedicated to advancing therapies for rare, metabolic, and life-threatening diseases.
- In October 2020, Rezolute announced a $41 million private placement which was led by CAM Capital with Federated Hermes Kaufmann, Surveyor Capital and BVF Partners participating, among others.
- Rezolute has initiated a global Phase 2b trial in Europe for their lead asset, RZ358, which is a potential treatment for CHI, a rare pediatric endocrine disorder.
- Rezolute is preparing to initiate a Phase 1 study, for RZ402, in Q1 2021. RZ402 is an IND-ready orally available plasma kallikrein inhibitor for the treatment of diabetic macular edema.
- Earlier this year, Rezolute received a rare pediatric disease designation, for RZ358, enabling eligibility for a priority review voucher.
- More information can be found at rezolutebio.com
The Senior Clinical Research Associate will report to the Director of Clinical Operations and will lead various clinical operational aspects of the trial management in collaboration with other clinical team members. Responsible for providing expert and overall support to the clinical study team in matters related to the clinical study documentation, investigational site management and other study related activities, including study start-up, vendor management during the course of the study, interim study management and monitoring as well as trial closeout activities.
- Participate in and/or chair meetings or conference calls with CROs, CRAs and cross-functional study teams
- Work closely with relevant functional areas (preclinical development, CMC, regulatory, clinical development) to accurately coordinate and support clinical study activities
- Participate in study feasibility assessments and selection of countries and sites for study conduct
- Develop collaborative partnership with study sites and oversee the training of the clinical sites to ensure protocol and regulatory compliance as well as quality and consistency of the data collection
- Perform on-site monitoring activities as needed and provide monitoring oversight by reviewing monitoring schedules, metrics, and reports
- Provide oversight and direction to study team members including vendors to ensure timely and quality study deliverables
- Assist in the development of key study documents (e.g. protocols, informed consents, case report forms, monitoring plans, etc.) and system set-up (e.g. UAT of EDC, IRT, Lab Portals, etc.)
- Accurately update and maintain clinical systems within project timelines, assist with projection and management of clinical supplies
- Coordinate and/or participate in investigator meetings
- Review and maintain study plans, reports and, escalate issues that may jeopardize deliverables or study activities
- Perform data listing reviews including during database lock and in preparation of final study reports
- Provide study progress updates, with timelines and metric reports and, proactively identify and resolve issues that arise during study conduct
- As we grow mentor and coach CRAs and Clinical Trial Assistants (CTA’s)
- Perform other duties and assignments as required for overall success of the projects. Duties may change based on the status of clinical programs and ongoing needs of the organization
- All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs
- Bachelor’s degree in a relevant scientific discipline or equivalent
- At least 5-7 years of relevant experience with at least 2-4 years in a CRA functional role in the pharmaceutical industry, Biotech or equivalent
- Strong knowledge of GCP and ICH guidelines required
- Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring
- Some experience in management of CROs and other vendors is required
- Excellent communication and interpersonal skills
- Detail and quality oriented
- Able to work independently and within a team
- Able to perform assignments with general instructions
- Able to solve complex problems, prioritize multiple tasks and plan proactively
- Experience developing tools and processes that increase measured efficiencies of the company
- Strong computer skills in MS Word, Excel, Outlook, and PowerPoint
- Must be willing to travel (25 -30%), COVID precautions will take first priority
Interested and qualified candidates should send their resume to firstname.lastname@example.org to the attention of Melissa Quinn.