Research Program Manager - Winthrop P. Rockefeller Cancer Institute

University Of Arkansas System Little Rock , AR 72215

Posted 2 weeks ago

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Closing Date:

05/05/2024

Type of Position:

Clinical Staff - Medical Services

Job Type:

Regular

Work Shift:

Day Shift (United States of America)

Sponsorship Available:

No

Institution Name:

University of Arkansas for Medical Sciences

The University of Arkansas for Medical Sciences (UAMS) has a unique combination of education, research, and clinical programs that encourages and supports teamwork and diversity. We champion being a collaborative health care organization, focused on improving patient care and the lives of Arkansans.

UAMS offers amazing benefits and perks (available for benefits eligible positions only):

  • Health: Medical, Dental and Vision plans available for qualifying staff and family

  • Holiday, Vacation and Sick Leave

  • Education discount for staff and dependents (undergraduate only)

  • Retirement: Up to 10% matched contribution from UAMS

  • Basic Life Insurance up to $50,000

  • Career Training and Educational Opportunities

  • Merchant Discounts

  • Concierge prescription delivery on the main campus when using UAMS pharmacy

Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening. To apply for the position, please click the Apply link/button.

The University of Arkansas is an equal opportunity, affirmative action institution. The University does not discriminate in its education programs or activities (including in admission and employment) on the basis of age, race, color, national origin, disability, religion, marital or parental status, protected veteran status, military service, genetic information, or sex (including pregnancy, sexual orientation, and gender identity). Federal law prohibits the University from discriminating on these bases. Questions or concerns about the application of Title IX, which prohibits discrimination on the basis of sex, may be sent to the University's Title IX Coordinator and to the U.S. Department of Education Office for Civil Rights.

Persons must have proof of legal authority to work in the United States on the first day of employment.

All application information is subject to public disclosure under the Arkansas Freedom of Information Act.

At UAMS we value Diversity, Equity and Inclusion.

For general application assistance or if you have questions about a job posting, please contact Human Resources at askrecruitment@uams.edu.

Department:

CI | Cancer Clinical Trials Operations

Department's Website:

Summary of Job Duties:

The Research Program Manager will be responsible for coordinating research start-up activities, developing IIT protocols, collecting and managing data, and overseeing ongoing protocol activities for oncology clinical trials in the Winthrop P. Rockefeller Cancer Institute (WPRCI). The Research Program Manager must be able to organize complex projects, provide attention to detail, and communicate effectively. The position will work closely with the Director, AD of Clinical Operations, investigators, and study team members (e.g. clinical research nurses, specimen technicians, statisticians, regulatory specialists, and financial analysts), as well as clinical and hospital staff to manage the day-to-day operations and objectives in support of the trial portfolio. The position will also be responsible for building relationships and communicating with clinical trial sponsors and industry representatives. The Research Program Manager will contribute information and ideas related to areas of responsibility as part of a cross functional team. The position ensures the activation of effective and efficient workflows and adherence to quality and ethical standards. The position maintains a working knowledge of the Code of Federal Regulations (CFR) and Good Clinical Practice (GCP) guidelines and is accountable for their application in daily activities.

Qualifications:

Minimum Qualifications:

  • Bachelor's degree PLUS Five (5) years research experience w/demonstrated proficiency in study planning/development, study coordination/management, and data collection OR Master's Degree PLUS Three (3) years research experience w/demonstrated proficiency in study planning/development, study coordination/management, and data collection.

  • CCRP, CCRC or equivalent professional certification and CRS certification required within 2 years of hire.

  • Knowledge and skill with word processing, spreadsheet, database, and e-mail computer software (e.g., Microsoft Word, Excel, Access, Outlook)

  • Working knowledge of clinical biomedical and/or behavioral research

  • Working knowledge of Federal Good Clinical Practice Guidelines

Preferred Qualifications:

  • Clinical Research Experience

  • Oncology Research Experience

  • Working knowledge of medical terminology

Additional Information:

Responsibilities:

  • Oversees adherence to regulatory requirements for study start-up, adverse event and protocol deviation reporting, ongoing reviews, and closeout activities in the timelines required by the study sponsor and the Institutional Review Board.

  • Ensures compliance with prescribed interventions and evaluations of the assigned protocol(s).

  • Prepares high-quality written documents for presentation; analyzes data and formulates conclusions.

  • Participates in the development and maintenance of electronic infrastructure including protocol budget review and clinical trial management suite.

  • Advises the investigator on administrative requirements necessary as required per protocol.

  • Monitors protocol status and advises investigator on requirements and deadlines.

  • Assists investigators in the development, preparation, and submission of research protocols and related documentation.

  • Confers with investigators and support staff to secure necessary documents for proposals.

  • Develops case report forms for investigator-initiated trials including data point identification and case report form review.

  • Assists the Quality Manager with the development, implementation, maintenance, and evaluation of quality assurance plan for conduct of clinical trials.

  • Interprets institutional, sponsor, and regulatory authority policies and guidelines related to clinical trial data collection, management, and reporting for early phase clinical trials.

  • Serves as a liaison for the investigators, research subjects, industry/funding contacts, and other clinical research professionals.

  • Ensures study activities are in compliance with the CFR, GCP guidelines, HIPAA regulations, and UAMS policies.

  • Serves as the point of contact and facilitator for internal and external audits and monitoring visits for early phase clinical trials.

  • Provides training for staff and investigators including site initiation visits (SIVs) and in-services to supporting departments and staff.

  • Assists internal and external stakeholders as needed with exceptional customer service.

  • Other duties as assigned.

Salary Information:

Commensurate with education and experience

Required Documents to Apply:

List of three Professional References (name, email, business title), Resume

Optional Documents:

License or Certificate (see special instructions for submission instructions)

Special Instructions to Applicants:

Recruitment Contact Information:

Please contact askrecruitment@uams.edu for any recruiting related questions.

All application materials must be uploaded to the University of Arkansas System Career Site https://uasys.wd5.myworkdayjobs.com/UASYS

Please do not send to listed recruitment contact.

Pre-employment Screening Requirements:

Annual TB Screening

This position is subject to pre-employment screening (criminal background, drug testing, and/or education verification). A criminal conviction or arrest pending adjudication alone shall not disqualify an applicant except as provided by law. Any criminal history will be evaluated in relationship to job responsibilities and business necessity. The information obtained in these reports will be used in a confidential, non-discriminatory manner consistent with state and federal law.

Constant Physical Activity:

Sitting

Frequent Physical Activity:

Hearing, Talking

Occasional Physical Activity:

Crawling, Crouching, Kneeling, Standing, Stooping, Walking

Benefits Eligible:

Yes


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Research Program Manager - Winthrop P. Rockefeller Cancer Institute

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