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Associate Project Manager, Quality Assurance, Comprehensive Cancer Center

Winston Salem, NC, United States
Job ID: 94406
Job Family: Professional Services
Status: Full Time
Shift: Day
Job Type: Regular
Department Name: 55811085045814-Comprehensive Cancer Center

Overview

JOB SUMMARY

Under administrative review, performs administrative and coordination work directed toward the design, implementation, evaluation, and review of the assigned project(s).  Oversees the coordination of recruitment, enrollment, and follow-up activities of the study.  Requires the use of judgment and discretion in performing the assigned duties and responsibilities related to the projects. Assists in the development of regulatory documents, data management systems, and institutionally required submissions.

EDUCATION / EXPERIENCE

Minimum Acceptable Qualifications:

  1. Bachelor's degree in education, public health, basic science, or a relevant clinical discipline. 
  2. Two years of research experience in coordinating and performing regulatory and/or data management activities for research studies and /or grants, especially clinical trials.
  3. An equivalent combination of education and experience.

Additional Desirable Qualifications:

  1. Master's degree in a relevant discipline.

LICENSURE, CERTIFICATION AND/OR REGISTRATION

  1. Must complete the CITI certification for Human Subject Research if not already completed
  2. All additional required WakeOne training for research coordinators

SKILLS / QUALIFICATIONS

  1. Excellent oral and written communication skills.
  2. Ability to provide direction to research staff.
  3. Knowledge of computerized data processing and statistical analysis. 
  4. Knowledge of medical terminology, especially within the field of oncology.
  5. EPIC/WakeOne proficiency. 
  6. Ability to use MS Power Point, Excel, Word
  7. Strict attention to detail in performing tasks required.

ESSENTIAL FUNCTIONS

  1. Assist in administration and coordination of quality assurance aspects of the assigned projects as directed.
  2. Responsible for ensuring the timeliness and quality of all required protocol data collected on the assigned clinical research studies.
  3. Perform regular data monitoring of data elements for protocols. Review patient data (source documentation) and protocol statistical endpoints with Clinical Protocol Data Management (CPDM) personnel, Principal Investigators (PI) and Biostatistics Shared Resource personnel, coaching staff as necessary to continuously improve the quality and efficiency of clinical research data captured by CPDM. 
  4. Review the early accruals of patients to clinical trials as part of the data auditing process.  Perform interim reviews of patient data, final reviews, and any other data monitoring as required. Work with the Biostatistics Shared Resource personnel to ensure that analytical data for clinical trials is collected and reviewed in a timely fashion and matches protocol objectives.
  5. Consult with the Cancer Center (CCC) Informatics staff and the CPDM Manager of Budget, Regulatory, and Data Management Services regarding computerization of CPDM data.  Provide input as to the types of information required, seeking to automate data collections and analyses whenever possible to improve the efficiency and quality of CPDM data collection. Assist in the implementation of a protocol compliance and data monitoring process for all Investigator Initiated Interventional trials.
  6. Coordinate with other Biostatistics staff, the Chair of the Clinical Research Oversight Committee (CROC) and/or Safety and Toxicity Review Committee (STRC) and others as identified to support overall quality assurance objectives and initiatives related to cancer clinical research studies in the CCC. 
  7. Assist with Adverse Event reporting processes within the Cancer Center, guiding and coaching CPDM team members as necessary to ensure compliance with NIH, NCI, and FDA requirements, as well as Safety and Toxicity Review Committee (STRC) reporting requirements for the CCC.  Advise PIs and CCC administration of any concerns related to study-related toxicities by keeping up to date with protocol specific reporting requirements.
  8. Foster communication and collaborative activities with affiliate institutions, the Cancer Center, research personnel, and investigators for multidisciplinary (multimodality) clinical research studies to ensure quality patient care, efficient and effective operation of protocol processes, and achievement of study-related objectives.
  9. May provide guidance to clinical research study personnel by providing training, direction, guidance, and feedback.  Assist with the development of appropriate training activities and provide feedback to Protocol Specialists engaged in data management activities in CPDM or other oncology-related areas/departments as necessary, as well as Clinical Studies RNs and Clinical Studies Coordinators regarding data and reporting procedures.  Develop standard operating procedures (SOPs) and present materials in seminar settings as needed. 
  10. Actively participate with and assist in institutional data audits under the guidance and direction of the Program Manager I and the data audit chairperson.  Assist in scheduling data audits and reporting final audit results to PIs.
  11. Assist with and provide reports as requested. Assist and back up other CCC Biostatistics staff to provide support to the Clinical Research Oversight Committee (CROC) and Safety and Toxicity Review Committee (STRC) as needed.
  12. Perform other related duties incidental to work described herein.