• 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

• 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 enhance predictability.• 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 support start-up phase.• 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.• Act as a mentor for clinical staff including conducting co-monitoring and training visits.• May provide assistance with design of study tools, documents and processes.• Convey features and opportunities of study to site.• Collaborate and liaise with study team members for project execution support as appropriate.

• 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 site issues.• 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 values.• 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, plans and training.• 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.• Forecast, develop, manage, and revise plans and strategies for: IRB/IEC and MoH / RA submission/approval, site activation, patient recruitment & retention.• Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis• Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance.• Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.

• 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.• Escalate quality issues as appropriate.• Ensure timely and accurate access and updates of applicable trial management systems and trial master file documents. • Assesses and manages test article/study supply including supply, accountability and destruction/return status. • Reviews site recruitment plans and takes action to drive recruitment in collaboration with the site staff on an ongoing basis. • Perform in-house activities related to management of study sites, including (but not limited to) payments, regular site phone contacts, remote data review• Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections as required.• Perform site qualification, initiation, monitoring and close-out visits in accordance with contracted scope of work and GCP.• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• 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.

• 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 study. Conducts and/or participates in study initiation visits prior to protocol activation, for both Northwestern and other participating sites. Works with Affiliate Site Coordinator and other members of QA team to activate affiliates.• 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 which Northwestern is considered the Sponsor of record.• 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 reports, and accrual status and compliance issues. Communicates findings to the PI during the conduct of the study and provides a summary of study data to the PI and statistician for the purposes of publication.• Audit: Participates in the conduct of internal audits per Audit Committee guidelines. Generates audit reports to be presented to the Audit Committee and DMC.• Performs other duties as assigned by Manager.

• 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 regarding patient visits and clinical procedures• 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 and co-authoring scientific papers for presentation and publication• 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• Processing of payments for research participants per protocol, creation of lab financial plans and budget/audit expenses• Oversight of repair and maintenance of lab equipment, ensuring that lab supplies are ready and available when necessary• Administration of budget, including negotiating with grant sponsors• Training, directing and assigning duties to and supervising research staff, students, residents or fellows, acting as a mentor in regard to education of junior coordinators• 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

• 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 review of case report forms (CRFs) and source documentation to ensure adherence to the protocol and consistency and scientific validity of the data• 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 investigations• 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