Roberta Adams Email & Phone Number

Eatontown, Nj, Us

SCRA monitors activities at clinical trial sites to assure adherence to Good Clinical Practices (GCP), standard operating procedures, and study protocols. Review regulatory documents as necessary, prepares site visit reports, and required letters and prepares study plans. Selection of potential clinical investigators and determines if facilities are adequate based on protocol requirements.

Morrisville, Nc, Us

- Delivers all relevant services/tasks in support of the planning and execution of quality driven clinical trials, in line with established targets. - Verifies Serious Adverse Events (SAE) reporting according to trial specification and ICH-GCP guidelines. - Ensures proactive risk identification and mitigation planning for assigned clinical trial sites. - Drives recruitment/retention follow up with clinical trial sites to track and support enrollment strategies. - Attends on-site audits, prepares for and follow-up on audits and inspections, collaborates and implements Corrective Action Plans (CAP) with investigative sites with oversight from Clinical Site Lead (CSL) and/or Trial Manager (TM). - Demonstrates technical proficiency within responsible areas, staying up-to- date on new practices and builds knowledge of emerging trends and advances within area. - Contributes to a continually changing environment, supporting a future- focused approach, leveraging competencies, tools, and technology. - Contributes actively to relevant teams as assigned.

Morrisville, Nc, Us

- Conducted site selection for potential sites to evaluate their capabilities for conducting a clinical trial. - Recommended sites to participate in clinical trial. - Managed assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and Syneos procedures. - Facilitated the preparation and collection of site and country level documents. - Performed Site Initiation Visit, ensured site personnel were fully trained on all trial related aspects. Performed continuous training for amendments and new site personnel as required. - Retrained site personnel as appropriate. - Conducted continuous monitoring activities (onsite and remote). Implemented site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety- Was accountable for continuously updating all electronic systems (global and local) relevant to perform job functions. - Ensured that study milestones for sites responsible were met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.) - Performed Site Closeout activities per SOPs and applicable regulations to ensure that site was aware of any follow up activity and archiving requirements. - Attended onboarding-, disease indication and project specific training and general CRA training as required.

Basel, Baselstadt, Ch

- Documented monitoring activities appropriately following Novartis standards.- Collaborated with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans, as needed.- Participated from audit organization and inspection readiness activities for monitoring and site related activities as required and ensured implementation of corrective actions within specified timelines.- Collected all clinical study essential documents.- Ensured that sponsor activities and timelines were in coordination with project requirements.- Implemented and documented communication with CRO and laboratories to ensure project progress.

Basel, Baselstadt, Ch

- Documented monitoring activities appropriately following Novartis standards.- Collaborated with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans, as needed.- Participated from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines.- Collected all clinical study essential documents.- Ensured that sponsor activities and timelines were in coordination with project requirements.- Implemented and documented communication with CRO and laboratories to ensure project progress.

Basel, Baselstadt, Ch

- Supported the day-to-day operations of clinical study execution in compliance with applicable SOPs, ICH/GCP guidelines and other regulatory requirements.- Tracked appropriate subject and site activity/metrics, performed quality check activities across components of the clinical study, etc.- Proactively identified and escalated issues that arose related to support functional deliverables.- Assisted in study set-up including but not limited to protocol/synopsis preparation, informed consent form preparation and review, systems (i.e., CTMS, IRT, etc.), study operational manuals, training manuals, investigator document review, various study plans (i.e., visit logs, drug inventory, monitoring plans, etc), and other study-related requests.- Collaborated with study team on the timely collection and archiving of TMF documents for assigned studies/programs.- Coordinated with regulatory on the ongoing submission of essential documents to regulatory authorities.- Assisted in the management of study completion activities with the CRO and the sites including TMF reconciliation, drug reconciliation, ensured that all documents were available.- Effectively communicated with study team members and work closely with Clinical Operations Lead/Study Manager.-Participated in process improvement and quality-related initiatives associated with study execution and deliverables.

Master Of Arts - Ma, Industrial And Organizational Psychology

Bachelor Of Arts - Ba, Business Administration And Management, General