Research Associate developing ultrasensitive immunoassays for biotech startup Spear Bio. Collaborating on innovative assay programs and advancing biomarker detection in early disease diagnosis.
About the role
- Clinical Research Associate overseeing global clinical trials for a biopharmaceutical oncology company. Collaborating with teams to manage trials effectively while ensuring adherence to guidelines and compliance.
Responsibilities
- Support all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out.
- Collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director.
- Direct and complete communication between the project team and site personnel to ensure appropriate training, understanding of project requirements, and milestones.
- Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites.
- Initiate and build professional relationships with clinical site staff.
- Partner with the CRO to ensure robust ongoing data monitoring strategies.
- Creation and development of study trackers.
- Develop and provide clear, complete documentation of study-specific meetings and action items.
- Responsible for the development and management of clinical trial documents.
- Ensure compliance of clinical trials with national regulatory requirements and company SOPs.
- Provide close oversight on findings from monitoring reports and communicate updates as needed.
Requirements
- Bachelors degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
- A minimum of 3+ years of clinical research experience in conducting clinical trials
- Prior phase II or III experience required
- A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP, and each step within the clinical trial process
- Experience with clinical studies in oncology and/or rare diseases is a plus
- Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams
- Ability to travel internationally to visit clinical sites and for study meetings (up to 20%)
- Excellent interpersonal and decision-making skills.
- Excellent written and oral communication skills.
Benefits
- Compensation packages based on skill set, experience, certifications, and location.
- Total compensation may include bonus, stock, benefits, and variable compensation.
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