Jennifer Baumann Email and Phone Number

Oncology Senior Clinical Research Associate

• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites• Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely• Provides regular site status information to team members, trial management, and updates trial management tools• Completes monitoring activity documents as required by PRA SOPs or other contractual obligations• Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues• Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed• Performs essential document site file reconciliation• Performs source document verification and query resolution• Assesses IP accountability, dispensation, and compliance at the investigative sites• Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines• Communicates with investigative sites• Updates applicable tracking systems• Ensures all required training is completed and documented• Serves as observation visit leader• Facilitates audits and audit resolution

• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.• May provide assistance to less experienced clinical staff.

• Multidisciplinary care coordination and management for patients on solid tumor cancer clinical trials including government, industry, and investigator-initiated studies.• Lead coordinator that manages clinic staff on several clinical trials including Phase I through Phase 3 trials.• Implements, designs, and coordinates new protocols and educates the clinical trial team on necessary procedures. • Identifies, assesses, and recruits eligible patients for specific protocols.• Completes an informed consent with patients while educating them about all aspects of the protocol.• Assesses patients for toxicities and reviews tumor measurements.• Collects lab samples, understand lab procedures per protocol, process lab samples using a centrifuge, and ship samples.• Meet with monitors to ensure protocol compliance and help complete all regulatory procedures.• Complete data using programs including Inform, IVRS, and Medidata.• Analyzes research data and regulatory forms to ensure that it meets the protocols' requirements.• Budget and monitor the expenses of each trial and make sure that our facility is consistent with the contract our facility has in place with the sponsor. • Ensures compliance with state and federal regulations including the FDA and IHC GCP to guarantee that the patient’s charts are audit ready.• Maintain all regulatory documents while keeping compliant with our facility’s IRB and WIRB.

• Led study and operational setup procedures within multiple EDC databases including eCRF design, development of a data validation plan and data management plan. • Coordinated data compilation for thoracic/GI/GU/melanoma cancer clinical trials, for hundreds of patients and a revolving large number of clinical trials.• Directed and supported study close out responsibilities with project teams resulting in effective interim analysis and locking of multiple studies within the agreed timelines within the sponsors’ expectations.• Assisted in IRB, FDA, and NCI audits concerning site adherence to study protocols per HIPAA guidelines which included proper data collection, documentation, entry, and storage.

• Processed and coordinated all provider enrollment and medical billing transactions for hospitals nationwide while monitoring and maintaining data integrity. • Coordinated the care of Medicare/Medicaid recipients concerning emergency medical needs and implementing and finalizing Medicaid/Medicare claims.• Focused on patient advocacy and navigation through the health care system with their individual financial needs while also aiding patients with their government benefits.