Responsible for remote 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.
Serves as an in-house CRA responsible for site management, data review, and / or query resolution on assigned projects.
Performs study evaluation, initiation, remote monitoring, and close out visits remotely. May monitor and / or co-monitor at sites when needed
Serves as a primary contact between the business and the investigative site and ensures proper documentation of site management communications.
Serves as back-up to the assigned field CRA and / or in-house CRAs.
In collaboration with the assigned field CRAs, 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 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.
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 the development of risk assessment thresholds and recommended actions for Key Performance Indicators (KPIs) for a study or program.
Makes recommendations about adjustments to KPIs and data analytics reviewed to ensure output continues to be appropriate.
Assists with and attends (as needed) Investigator Meetings on assigned studies.
Authorized to request site audits for reasons of validity.
May help ensure timely and appropriate site payments and updates to systems as required to ensure proper timing and amount of payments.
Bachelor's Degree Degree in scientific discipline or health care preferred.
Minimum of 2 years of clinical experience required.
Equivalent combination of education, training and experience may be acceptable.
Knowledge of clinical research process and medical terminology.
Written and verbal communication skills including good command of English language.
Good organizational and problem-solving skills.
Ability to manage multiple priorities within various clinical trial.
Ability to reason independently to assess and recommend specific solutions in clinical settings.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Ability to understand electronic data capture including basic data processing functions.
Familiarity with current International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and applicable regulations to the conduct of clinical research.