Provide project related assistance for all assigned project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.
- Serves as an in-house CRA responsible for site management, data review, and/or query resolution management on assigned projects. Collaborates with (field) CRAs on assigned sites. Serves as Novella’s in-house expert on assigned sites (for example, patient enrollment, protocol compliance, study site staff issues, IRB and regulatory document status, data status, and other site metrics).
- Serves as a primary contact between Novella and the investigative site and ensures proper documentation of site management communications. Serves as back-up to the assigned (field) CRA and/or CSAs.
- In collaboration with the assigned (field) CRA, performs routine site management activities, including site training, assistance with site questions, patient recruitment and retention management, study supplies management, and other activities needed to ensure that assigned sites are conducting the study(ies) as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
- Collaborates with assigned (field) CRAs to resolve and document outstanding site issues/action items.
- Reviews the quality and integrity of patient data at assigned sites through the in-house (remote) review of electronic CRF data. Ensures timely transmission of clinical data from assigned study sites, and works with sites to resolve data queries.
- Assists with final data review and query resolution through database lock; inclusive of patient profile and data listings review.
- Helps ensures timely and appropriate site payments and updates CTMS as required to ensure proper timing and amount of payments .
- Performs study evaluation, initiation, remote monitoring, and close out visits via WebEx or teleconference as appropriate.
- Performs risk–based quality trial management to identify, assess, control, communicate and review study risk. This data surveillance is performed at specified intervals and throughout the duration of the trial per the study plan.
- Assists with and attends (as needed) Investigator Meetings on assigned studies.
- Authorized to request site audits for reasons of validity.
- Performs other duties as requested by Management.
Qualifications and / Or Requirements
- Bachelor's Degree life science.
- Life sciences graduates upto 1 year of experience.
- Basic knowledge of Microsoft Excel and Word.
- Good Communication skills.
- Ability to exercise judgment within procedures and practices to determine appropriate action.
- Ability to prioritize and coordinate multiple work requirements to meet deadlines.
- Ability to establish and maintain effective working relationships with co-workers, managers and clients.
- Ability to communicate with the ‘Clients’ & ‘Project Managers’ with accurate perception of speech.
- Ability to accommodate ad hoc requests as per project requirements.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.