Debra Evans Email & Phone Number

Morrisville, Nc, Us

Dublin, Ie

Gene Editing Using CRISPR-Cas9 Modified CD34+ hHSPCs• Initiate and monitor procedures at clinical study centers; inclusive of training of study site personnel, oversight of protocol adherence, and data verification of source documents; troubleshoot and resolve routine study conduct issues.• Work with clinical sites and data management team to facilitate the resolution of all data management queries.• Ensured all source data verification is complete prior to data cuts. • Regularly follow up on all screened subjects through enrollment confirmation.• Proactively schedule pre-mobilization, IP product pre-shipment, and Busulfan pre-conditioning teleconferences to occur for each subject with sites and sponsor.• Train site staff on Apheresis Collection Manual as well as the IP Product Receipt, Storage and Infusion Manuals.

• Provide data clean up for a Phase III vascular access study.

Marietta, Ga, Us

Provide monitoring and site support for a Phase IIb inpatient trial for the treatment of Seizures Disorders.

• Provide monitoring and site support for the COBRA PzF Coronary Stent • Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by the sponsor. Prepares monitoring reports and letters per the timelines defined by CeloNova

• Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study• Collaborates with the ISSC department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents • Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities• Trains site staff on the EDC system • Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in Novella SOPs by using approved Novella/sponsor templates and reports• Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required• Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries• Serves as primary contact between Novella and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested• Review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA

Boston, Ma, Us

• Monitor and provide general site support for the following studies: o Phase I DNA replacement therapy for the treatment of a genetic disorder in children. Assist with the development of the Data Management Plan, eCRF design and study database. o Lead study start-up activities (Author IC, CRF and study database design) in a Device IIS Trial.

Deerfield, Illinois, Us

• Functioning as primary point of contact for Companion Diagnostic (CDx) Program.• Monitor and provide general site support for the following studies: o Trial to identify mutations using EGFR gene amplification in subjects with glioblastoma multiforme formalin-fixed, paraffin-embedded specimens. o Trial to measure relative expression of total EGFR mRNA and detect EGFRvIII mRNA in subjects with glioblastoma multiforme, formalin-fixed, paraffin-embedded specimens.

Marlborough, Ma, Us

Primary point of contact for 48 sites in the US>

Abbott Park, Illinois, Us

Lead the study team in the planning and management of assigned clinical trials (Phase I-III) including the coordination of cross-functional areas for the initiation, conduct and completion of clinical studies on time and within budget.

Responsibilities include: SAE reporting for multiple protocols while maintaining strict adherence to FDA reporting requirements; Assist in protocol development; Develop study specific safety review plans; CRF review; database reconciliation; Author initial and follow up expedited safety reports for submission to the FDA, including analysis of similar events as they pertain to previously reported SAE’s submitted to the FDA and EU Regulatory agencies.