We are seeking an in-house Senior Clinical Research Associate to assist with operational oversight of Alpine’s clinical development program for a novel anti-cancer immunotherapeutic. This individual will work alongside the Project Lead on CRO management, site management, and site monitoring. This position is critical for helping ensure the timely, quality conduct of clinical studies according to protocols, Good Clinical Practice, Standard Operating Procedures, and all applicable regulations.
- Assist the Project Lead in managing defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines
- Oversee CRO monitoring activities, including site qualification, study initiation, interim monitoring, and close out visits and completion of associated reports and follow-up letters
- Develop and/or assist in the development of trial materials (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, monitoring guidelines, Site Initiation Visit materials, site tools and worksheets, and investigational product administration guidelines)
- Work closely with, and provide training to, CRO staff, study site staff, and field-based CRAs
- Create, monitor, and present key study performance metrics with cross-functional Alpine study teams
- Work with the Medical Monitor, Director of Data Management, and Project Lead to review data listings for accuracy, oversee data discrepancy management, and perform associated training/retraining to site staff and CRAs as needed
- Work with the CRO to manage start-up activities at trial sites, including IRB/IEC submissions and ensuring the collection and review of required essential documents
- Escalate any issues in a timely manner to the Clinical Trial Manager
- Develop strong and effective working relationships within Alpine’s Clinical Development team and other functional departments and CROs
- Ability to travel for periodic site monitoring and/or co-monitoring activities and attend investigator meetings or vendor visits/audits, as required
Desired Skills and Experience
- BA/BS or equivalent or any relevant and qualifying training with a minimum of 4 years of relevant clinical trial management experience, preferable in a pharma/biotech setting
- SOCRA or ARCP certification preferred
- Strong working knowledge of FDA & ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
- Highly responsive and proactive, a team player
- Excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment
- Exceptional attention to detail
- Proficiency with MS Office products Word, Excel, PowerPoint, Sharepoint
Alpine team members enjoy competitive salaries, equity participation (stock options), and an excellent benefits package including health and life insurance, a 401 (k), FSA, and generous paid time off benefits.
Alpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.