Responsible for remote and on-site monitoring activities to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions
• Serves as an in-house CRA responsible for site management on assigned sites.
• Performs study evaluation, initiation,remote and on site monitoring, and close out visits remotely as appropriate. May monitor and/or co-monitor at sites when needed.

• Serves as a primary contact between IQVIA and the investigative site on assigned sites and ensures proper documentation of site management communications.
• Serves as back-up to assigned field CRAs and/or in-house CRAs
• 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 remote review of electronic case report form (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

• Assists with the development of patient profile and data listings for review during data cleaning activities

• Assists with and attends (as needed) Investigator Meetings on assigned studies

• Performs other duties as requested by Management.

• May help ensure timely and appropriate site payments and updates the clinical team as required to ensure proper timing and amount of payments.

Qualifications
• Degree in scientific discipline or health care preferred.
• At least 1 year of onsite monitoring activities

• Regulatory experience is a plus
• Knowledge of clinical research process and medical terminology.
• Good written and verbal communication skills including good command of English language. (Mandatory)
• Good organizational and problem-solving skills.
• Ability to manage multiple priorities within various clinical trials.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com