Additional Info

1. Responding rapidly and comprehensively to PI/sponsor requests; determining and disseminating expectations to the project team and sites; maintaining sponsor-specific guidelines. Develop and ensure that tasks are being conducted in accordance with study-specific protocols, GCP, FDA regulations, and standard operating procedures. To ensure subject safety and the highest possible data quality, works closely with each affiliate site, team member, and other UNMC divisions necessary, exhibits a thorough attention to detail to rapidly respond to study needs.(D)
2. Coordinates and participates in group meetings and committees. (E)
3. Serves as a liaison to the clinical team and investigators at UNMC and to affiliate site employees and investigators participating in investigator-initiated multi-site and national cooperative group protocols and research projects.(E)
4. Is a resource and provides education to Principal Investigators (PI), case managers, CRAs and data managers at UNMC and affiliate sites to assure accurate protocol management and accurate, timely data collection.(E)
5. Evaluates progress of investigator-initiated multi-site, Big 10 and ACCRU research projects with PI.(E)

1. Oversees the progress of UNMC investigator-initiated multi-site clinical cancer research projects and ensures that they are conducted, recorded, and reported in accordance with the protocol, standard operating procedures(SOPS) Good Clinical Practice (GCP), and applicable regulatory requirement(s).(D)
2. Assist in the design and execution of high quality UNMC investigator initiated multi-site clinical cancer studies in compliance with FDA and ICH requirements. (E)
3. Assists with protocol and case report form development, drafts trial-related documents and operational procedures, collects regulatory documents and maintains clinical files.(E)
4. Monitors participating sites (UNMC also) case report forms and assure the study PI/sponsor that the protocol is being conducted as planned. Monitoring is a Quality Control, continuous process during entire trial. (E)
5. Work with the UNMC CPDMU PRMS Office to resolve compliance issues identified during the PRMS Audit/DSMC process. (E)
6. Manages project meetings: providing frequent status reports; serving as center point-of contact for PI/sponsor, internal teams and site staff(E)
7. Summarizes various laboratory and clinical measurements and prepares summary data for submission to cooperative groups.(E)
8. Contacts physicians, patients, and other data sources concerning missing or ambiguous data and obtain follow-up information. (E)
9. Verifies Informed Consent Document. (E)

1. Submission of regulatory modifications to protocols, IRB and SRC applications, and informed consents; Preparation of continuing reviews, internal and external adverse events, and other reports and submits to the IRB, SRC, FDA, DSMC, and sponsoring agency as required; Maintenance of the regulatory documentation as appropriate to meet federal and sponsoring agency guidelines.(D)
2. Evaluates which Big 10 and ACCRU protocol activation#s, closures and amendments are to be processed for UNMC. (E)
3. Relates Big 10 and ACCRU protocol information to other UNMC departments (E)
4. Track and monitor timeliness of submissions and adverse events as required by Big 10 and ACCRU.(E)
5. Work closely with the IRB and affiliates to manage Big 10 and ACCRU regulatory requirements. (E)

1. Attend continuing education programs related to the clinical area. Review literature related clinical area. Communicates advances in practice or research care to other health care professionals through in-services, presentations and/or publications. (E)
2. Assure performance of behaviors that meet the requirements of the UNMC culture including: demonstrates behavior that fosters a positive team environment, demonstrates behaviors that promote diversity, applies continuous quality improvement principles, seeks the customers# requirements and strives to meet them and designs personal action plan for professional development. (E)
4. Consults with the Director and senior leadership of the Fred&Pamela Buffett Cancer Center about the progress and the mission of investigator-initiated multi-site and Big 10 and ACCRU group protocols and research projects.(E)
5. Other duties as assigned. (D)

Determined within a relatively short period of time

Proper management as the Sponsor of the trial is essential to the Cancer Center and its ability to remain an NCI-designated Cancer Center

Significant

Clinical Trials Projects Manager, Taylor Johnson, Direct, Daily

No

NA

Office

Full extent of working environments TBD by position activities

Adult (18-65 years),Geriatric (65 and older)

Full extent of activities TBD by position duties.

Full extent of lift/carry/push/pull activities TBD by position duties.

Full extent of exposure TBD by position duties.

Full extent of protective equipment TBD by position duties.

Full extent of hands/wrists TBD by position duties.