Barbara Ruttan Email and Phone Number

The Site Relationship and Excellence Partner (SREP) is the main Client point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site • Responsible for site operations, oversight, and building and retaining relationships from site activation through the lifecycle of studies • As part of the oversight responsibilities, utilize and interpret data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks • Accountable for identifying Clinical Research Associate (CRA) performance issues and is responsible for ensuring appropriate corrective and preventative actio ns are put in place • The SREP is the face of Client and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and Client’s reputation is that of Partner of Choice. • The SREP proactively collaborates and provides local intelligence to country outreach surveys, targeted sites strategies, study design, and Client pipeline opportunities • This role is accountable for study start up, activation, and execution to the plan for targeted sites. In addition to being the main point of contact, the lead will help coordinate with other roles and functions that will interface with target sites, thereby, simplifying site Client communications and enhancing overall visibility into and confidence of quality of site-level activities Currently working on oncology high profile trials.

Act as a central point of communication between investigator, CRA, and the clinical team for clinical trial related activities to assure trials are conducted on time/budget, while following GCP/ICH guidelines. Manage site identification, selection, and assist with CRA training and support for large inpatient trial. Act as liaison between research scientist and CRAs. Lead Monitor position includes providing second level support to investigators by facilitating endpoint, SAE, and query resolution between endpoint committee, sites, CRAs, and clinical team. Focus on supporting CRAs and sites with vendor issues including IVR, central lab, remote data entry, monitoring questions, and central ECG. Assist with recruitment, track site progress for CRAs covering multiple time zones, facilitate and collect regulatory documents, execute site initiation, monitoring to include source document verification and adherence to the protocol, and closeouts. Ensure compliance and drug accountability, identify and track problems. Therapeutic areas include cardiovascular, neurology, and respiratory.

Same position as above. Therapeutic areas include cardiovascular, neurology (MS, fragile X), oncology.

Responsible for the establishment, monitoring, and close-out of clinical trial while assuring adherence to GCP/ICH standards. Duties included site selection, identifying and contacting potential investigators and ensuring adequacy of research. Interim monitoring ensured CRF completeness and accuracy per source document verification, review adverse events and SAEs according to GCP standard and to maintain quality data and investigator compliance. Resolved outstanding queries, maintained regulatory documents, and proper drug storage and accountability. Therapeutic areas include cardiovascular, pediatric anesthesia, and stroke trials.

Therapeutic areas included transplant, CV, and CNS.