Anna M. Email & Phone Number

Chicopee, Ma, Us

Massachusetts, United States

Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes. Activities include qualifying potential investigational sites, initiating clinical trials, maintaining study files, providing instruction to site personnel, and study close out. Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance with applicable regulations. Ensures the… Show more Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes. Activities include qualifying potential investigational sites, initiating clinical trials, maintaining study files, providing instruction to site personnel, and study close out. Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance with applicable regulations. Ensures the integrity of clinical data and the study is conducted in compliance with approved protocol, GCP, applicable regulations, and SOPs. Manages the investigative site staff to facilitate deliverables, e.g., subject enrollment, and data deliverables. Verifies proper management and accountability of investigational product (IP). Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate. Manages essential documents as required by local regulations and ICH-GCP guidelines before, during and after a clinical study, and assists with resolution of investigational site/data queries. Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation. Participates in audit preparation and follow-up activities as needed. Show less

New Britain, Connecticut, United States

Ensures proper research conduct in accordance with Federal, State and local policies and Good Clinical Practice and protocol adherence. Critically evaluates research protocols for feasibility, resourcing and logistical implementation. Provides direction and guidance to the Principal investigator regarding protocol requirements, institutional guidelines and good clinical practice. Provides training & education and key clinical information to the clinical team to ensure all research required… Show more Ensures proper research conduct in accordance with Federal, State and local policies and Good Clinical Practice and protocol adherence. Critically evaluates research protocols for feasibility, resourcing and logistical implementation. Provides direction and guidance to the Principal investigator regarding protocol requirements, institutional guidelines and good clinical practice. Provides training & education and key clinical information to the clinical team to ensure all research required elements are performed and conducted in accordance with the study guidelines. Responsible for scheduling assessments/tests/activities to meet research objectives and study protocol compliance. Manages subject registration into all required systems and maintains relevant logs. Ensures reliability and validity of clinical research trial data. Maintains accurate source documents related to all research procedures. Facilitates documentation of protocol specific training, sponsor required training and delegation of tasks by the PI. Routinely leads research meetings and presents information on study, patients, data and monitoring. Protects the rights and welfare of research participants by: serving as a patient advocate and working alongside the PI to ensure proper informed consent is provided and documented. Promptly reports any unanticipated problems involving risk to research participants or others to the IRB and the sponsor in compliance with Federal and institutional policies and procedures. Maintains effective and ongoing communication with sponsor, key partners, research participants, PI and regulatory bodies (i.e. IRB) during the course of the study. Show less

Hartford, Connecticut, United States

Coordinate and facilitate the appropriate conduct of clinical research trials in oncology which may be supported by the NCI, industry, cooperative groups or HHC system alliances. Coordinate and conduct the operation of clinical trials as per GCP and ICH guidelines including participant recruitment; informed consent; continuous monitoring of protocol for compliance and patient safety; source document review; data entry; sponsor monitoring. Interact/collaborate with all physicians, other members… Show more Coordinate and facilitate the appropriate conduct of clinical research trials in oncology which may be supported by the NCI, industry, cooperative groups or HHC system alliances. Coordinate and conduct the operation of clinical trials as per GCP and ICH guidelines including participant recruitment; informed consent; continuous monitoring of protocol for compliance and patient safety; source document review; data entry; sponsor monitoring. Interact/collaborate with all physicians, other members of the health care team and participants/families across the system in a manner that supports the conduct of clinical trials. Required to attend the respective system-wide Disease Management Team meetings and present the clinical trials to potential investigators. Collaborate with and support other clinical trial staff across the system to ensure highest quality clinical research activities. Document relevant data collections into various sponsor electronic data capture systems and complete data entry within protocol timelines. Prepare study calendars and materials; maintain participant tracking logs and screening/enrollment logs. Assist regulatory staff with study regulatory reporting requirements and IRB policies for protocol deviations, safety reporting and continuing reviews. Assist research account specialist of CCRO with clinical trial billing in the resolution of related queries. Assist/coordinate preparation for internal and external audits. Handle all confidential information appropriately. Show less

Reno, Nevada Area

Collaborates with study Principle Investigators to recruit new clinical trials and enroll oncology patients onto clinical trials through developing relationships with sponsors, collaborators, and external agencies. Responsible for managing subjects enrolled on clinical trials at Renown, including calendar management, data collection and submission, documentation, and reporting adverse events. Participates in clinical trial compliance through monthly audits and reports to appropriate… Show more Collaborates with study Principle Investigators to recruit new clinical trials and enroll oncology patients onto clinical trials through developing relationships with sponsors, collaborators, and external agencies. Responsible for managing subjects enrolled on clinical trials at Renown, including calendar management, data collection and submission, documentation, and reporting adverse events. Participates in clinical trial compliance through monthly audits and reports to appropriate collaborator. Show less

Reno, Nevada Area

Collaborates with Clinical Research Coordinators for studies including the following: assist with participant inclusion/exclusion eligibility for clinical trials registration, navigate and ensure protocol data entry into multiple clinical trial electronic systems, monitor protocol compliance requirements and communicate updates to Cancer Research team, and maintain an effective and efficient data management workflow.

Reno, Nevada, United States

Verify physician infusion orders (Standard of Care and Clinical Research) for patient information and accuracy, provide excellent customer service and build relationships with local providers, scheduling patients for appropriate treatments, maintain and update order set, forms, and contact lists of local providers, and use high level of problem-solving skills and resourcefulness.

Verification of insurance eligibility, determining estimated cost for services being rendered, explaining and obtaining signatures on admission, clinical and financial forms, and documenting all information collected timely.

Master'S Degree, Clinical Research Administration

Bachelor Of Arts - Ba, Research And Experimental Psychology