What are the responsibilities and job description for the Clinical Trial Associate position at LanceSoft?
Work Location : HYBRID / San Bruno California / 3 days on site - 2 days remote
Work hours : 8-5 M-F
On Call : No
Extension : Possible
Contract to Hire : No (maternity leave coverage)
Travel : No
Interview Process : 2 video / remote interviews (back to back if possible)
Description
The Clinical Study Manager will be an integral member of the growing Program Operations & Implementation (POI) team. We are seeking to improve the way clinical studies are conducted and evidence is generated using advanced software and sensor technology. In this role, your team will help to oversee the planning and execution of clinical studies utilizing solutions. You will partner closely with a variety of teams, as well as partners from industry.
As a Clinical Study Manager on POI team, you will lead cross functional teams in clinical study design, planning, and execution (start-up to close-out). You will be accountable for overseeing study deliverables and work streams, ensuring relevant practices (e.g. Good Clinical Practices, Good Pharmacoepidemiology Practices, Common Rule) and relevant Standard Operating Procedures (SOPs) are met as required.
Responsibilities
- Oversee / collaborate all operational aspects for the implementation of clinical study activities from study start-up through database lock, ensuring relevant practices (e.g. Good Clinical Practices, Good Pharmacoepidemiology Practices, Common Rule) and relevant Standard Operating Procedures (SOPs) are met.
- Work closely with cross-functional teams on clinical study delivery for sponsored and externally Sponsored research projects.
- Drive development of study-related materials, such as Monitoring Plans, Trial Master File Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, informed consent, site instructions / training, and other aspects of study operations.
- Review monitoring / data reports, protocol deviations to ensure reliable quality data is delivered; coordinate / manage Contract Research Organizations (CROs) on site selection, Institutional Review Board (IRB) submissions, site initiation and close-out planning.
- Communicate directly with study site staff and investigators; track patient recruitment and progress to study timelines; support safety reporting and IRB submissions; maintain and report metrics for clinical site performance.
Qualifications
Minimum Qualifications :
Preferred Qualifications :
