Project Manager I - Clinical Trials

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

Cures Start Here.
At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network.

Careers Start Here
This individual will manage and coordinate activities related to the recruitment and assessment of patients and partners in the study. Specifically, s/he will assist in the preparation of IRB materials and federal progress reports; design and update as needed a REDCap tracking and data collection system; using LifeData, develop a smartphone application for ecological momentary assessment; interface with the clinical research coordinators who will identify potentially eligible patients; consent couples coping with late stage cancer under the supervision of PIs; conduct baseline laboratory sessions under the supervision of PIs; track participant flow; monitor and facilitate acquisition of ecological momentary assessment and follow-up data; and ensure payment of participant incentives. S/he will communicate frequently with the Project Director, Data Manager and Data Technician at Duke University to ensure consistency of activities across sites.

- Review and compare Duke protocol and IRB materials to those for ASU to create and ensure parallel processes (note authorization agreements in place for UW and FHCRC with ASU)
- Design and update as needed UW-hosted REDCap tracking and data collection system; create access for pertinent personnel at Duke and ASU
- Connect with pertinent FHCRC- and ASU-based marketing and minority affairs departments to discuss recruitment strategies and ensure attainment of minority enrollment goals; troubleshoot as necessary
- Train personnel at Duke re REDCap system and data entry to ensure consistency across sites
- With guidance from the PIs and consultants and using LifeData, develop a smartphone application for ecological momentary assessment; test, pilot and trouble-shoot as necessary; incorporate to the extent possible random timing within time blocks and within-couple receipt within certain time windows but not at the exact same time
- Interface with PIs and the Seattle-based clinical research coordinators to identify and refine recruitment strategies
- Revisit with PIs the number of potential patients meeting inclusion criteria
- Identify potentially eligible patients, either in isolation or with the Seattle-based breast and colorectal clinical research coordinators
- Approach and consent 79 couples coping with late stage breast cancer
- Approach and consent 138 couples coping with late stage colon or rectal cancer
- Set up and maintain lab, including necessary audio- and video-recording equipment
- Conduct 217 baseline laboratory sessions; this entails scheduling the sessions, greeting couples, administering baseline questionnaires via REDCap, recording couple conversations, and training participants on how to access the smartphone application and complete ecological momentary assessments over the following two weeks
- Troubleshoot issues with the smartphone application; monitor data collection and provide descriptive statistics to team, especially during start-up but periodically over time
- Aggregate audio- and video-tape data across sites; prepare for observational coding
- Prepare audiotape data for analysis of fundamental frequency
- Coordinate and run multi-site team meetings
- Draft ASU IRB modifications and IRB annual reports/ renewals (note authorization agreements in place with UW and FHCRC)
- Assist in preparation of annual report to funding agency; gather pertinent information from all sites
- Review and confirm scoring syntax for all questionnaire-based measures
- Conduct literature review and create table providing normative data for all measures, if available
- Synchronize data across recruitment sites
- Ensure that participant incentives are paid in a timely fashion
- Monitor participant retention, provide monthly reports and discuss/ troubleshoot with investigators as needed
- Participate as a co-author in the preparation of abstracts, presentations and manuscripts
- Participate in data interpretation and planning for next-step intervention trial(s); provide input based on face-to-face interaction with couples

Minimum Qualifications:
- BA/BS in the sciences, applied health field, information technology, or business
- Minimum of three years post-master's or five years post-bachelor's related project/study managment experience in health-related research administration (laboratory, clinical, or prevention)
- Experience as a research project coordinator or manager
- Strong supervisory skills and budgeting experience
- Quality assurance experience
- Experience using Microsoft Word and Excel to support tasks listed above

Preferred Qualifications:
- Background in Psychology or other social science
- Master's degree in social or biological science
- Experience with Clinical Trials
- Experience approaching and consenting clinical samples
- Experience working with individuals undergoing cancer treatment or cancer survivors (or persons coping with other chronic illnesses)
- Experience managing observational studies or clinical trials

Key Skills and abilities:
- Ability to work independently as well as within a team, and to take initiative
- Systems thinking and organizational skills, i.e., project coordination

To apply for this position, please CLICK HERE

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