Danielle Malone Email & Phone Number

Minnesota, United States

United States

Rochester, Minnesota Area

Clinical Research Associate• Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures• Site management to ensure proper adherence to protocol, source data verification and assess CRF entries• Develop, review and edit clinical trial-related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists• Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval, where required• Perform pre-study initiation, interim monitoring and close out visits, as required• Carry out drug formulation administration procedures and documentation records• Ensure adequacy of drug shipment and drug accountability• Liaison between the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives, as required• Attend investigator meetings, as required• Provide support to the Project Manager/Country Manager with ad-hoc tasks, as required

• Management of protocol development process from initial concept through completion• Ongoing management of protocol document and process through editing, amendments, proofing, and coordination of study logistics • Accurately applies investigators' scientific data into a cohesive format for the protocol document and associated procedures, that is consistent with internal and external policies and regulatory requirements• Liaison between sponsors and external academic or community institutions • Writes and provides input to standard operating procedures and working instructions• Works with team members to ensure internal and external processes are established and functioning• Works with Legal Contracts Administration for executing contracts and confidentiality agreements, between sponsors, ACCRU and ACCRU members • Develops and carries out staff training and mentoring, if necessary

• Analyzes and develops a study protocol• Aids in the management of all phases of multiple studies• Expert resource and mentors other internal and external study/protocol personnel• Resolves problems and contributes to discussions on research study design, overall project management and study results.• Participates in designing, organizing and monitoring protocols• Resource for Phase I data audits