Allison Rogowski Email & Phone Number

Wilmington, NC, US

Chicago, Illinois, US

• Conduct the live and online course instruction using materials developed by the NUCATS Institute
• Provide feedback to the NUCATS Institute on ways to enhance the course and better train clinical research coordinators in their professional roles
• Incorporate experience as a CRC into instruction to enhance the experience for students
• Review pre-work assignments to tailor the content to the experience of the attendees as appropriate
• Maintain working current knowledge of trends and regulations in clinical research and apply to the instruction of the course content
• Collaborate with NUCATS Institute Education coordinators on live and online program facilitation

Durham, North Carolina, US

• Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to.
• 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 as appropriate
• 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. May.

• Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve.
• Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
• Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
• Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high-performance culture.
• Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL / Sponsor training requirements and study specific procedures.
• Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.

• Clinical sites’ main point of contact, accountable for quality and delivery of sites from Initiation to close out of the trial.
• Oversees conduct of trial at designated sites to ensure rights and well-being of subjects are protected.
• Ensures quality and integrity of the data, and ensures the sites are in compliance with protocol, study requirements, GCP and applicable regulatory requirements.
• Perform site qualification, 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 training to sites and establish regular lines of communication to manage ongoing project expectations and issues.

• Protocol initiation: Reviews new protocols, specifically sections relating to registration procedures, records to be kept, eligibility criteria, and adverse event reporting. Collaborates in eCRF development for each.
• Protocol registration: Verifies eligibility of and registers/randomizes participants to studies monitored by the DMC.
• Data review: Reviews case report forms submitted for accuracy, protocol compliance and completeness. If errors exist, generates queries and submits them to the coordinator/data manager associated with the protocol.
• Toxicity review: Reviews all adverse events submitted to ensure appropriate reporting requirements have been met. Follows all serious adverse events through resolution. Manages safety report review for all trials for.
• Phase I reporting: Summarizes and presents toxicity data on phase I studies for cohort analysis prior to dose escalation.
• General reporting: Reports data to the DMC as described by the Data and Safety Monitoring Plan and DMC requirements. Includes presentation of toxicity data, response data, Study Activity Reports, audit reports, FDA.

• Participation in the planning and conduct of research studies, review of project and protocol and recommendation of strategies to expedite study
• Recruitment and retention of the trial participants covering informed consent, administration of tests, physical function assessments and/or questionnaires, collection and compilation of responses, information and data.
• Monitoring and maintenance of systems for effective participant and data flow, including design and construction of experimental stimuli
• Management of study databases which includes ensuring that data is collected and entered correctly
• Review and analyzation of data, which includes creating computer models, graphs, reports, and summaries for use in publications, professional journals and grant applications; writing of portions of grant applications.
• Creation and maintenance of study manuals regarding operating and safety procedures, ensuring that all study documents are compliant with current local, state and federal regulatory guidelines, requirements and laws

• Recruitment and coordination of the trial subjects covering informed consent, screening and inclusion of the subjects adhering to safety and compliance issues
• Coordination and management of the clinical trial, communication with sponsor and authorities, visit coordination, sampling, time management and investigational product accountability
• Data collection and management, collection of source documents, using and developing CRFs, registration and management of AEs, filing and archiving, managing monitoring visits, responding to queries
• Management of clinical trials conducted at central and satellite clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity through internal monitoring activities, including.
• Strong working knowledge of clinical research processes, Good Clinical Practices, International Committee on Harmonization Guidelines, federal regulations and applicable local laws pertaining to clinical research.
• Strong computer and technology skills, more than proficient at Microsoft Word, Excel, and PowerPoint and have had valuable experience working with electronic data capture databases

• Performed and assisted with multiple mouse experiments
• Duties included: surgery, oral gavage, intraperitoneal injection, tumor measurement and extraction
• Required to multitask in order to design and run multiple experiements at a time, able to efficiently follow written as well as oral instructions
• Co-managed the lab; duties included inventory, ordering which required strong organizational skills

Master Of Science (M.S.), Molecular Biology

Bachelors Of Science, Biochemistry, Psychology

Education record