Research Program Manager - Regulatory Team

Posted:
8/28/2024, 2:22:20 AM

Location(s):
Arkansas, United States ⋅ Little Rock, Arkansas, United States

Experience Level(s):
Mid Level ⋅ Senior

Field(s):
Legal & Compliance ⋅ Product

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Closing Date:

09/11/2024


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 [email protected].


Department:

CI | Regulatory Team


Department's Website:


Summary of Job Duties:

The Research Program Manager will be responsible for coordinating the regulatory maintenance staff. Assists in hiring process of Regulatory Specialists I-III that are responsible for regulatory maintenance and routinely evaluates staff performance, initiating disciplinary action when necessary. Will serve as the technical expert for the maintenance regulatory team. Position must be able to organize complex projects, provide attention to detail, and communicate effectively. Manages the day-to-day operations and objectives in support of the assigned portfolio. Contributes information and ideas related to areas of responsibility as part of a cross functional team. Ensures effective and efficient workflow and adherence to quality standards for staff/program and self. Position maintains a working knowledge of the Code of Federal Regulations and the code of conduct for human research. The employee will work directly with pharmaceutical company sponsors, institutional investigators, and research staff. Conducts complex work important to the organization. Contributes to measurable team and/or organization objectives.


Qualifications:

Minimum Qualifications:

  • Bachelor's degree in one of the social or behavioral sciences such as psychology, social work, public health, sociology, anthropology, health science or related field Plus 5 years of clinical research experience w/demonstrated experience/proficiency/study planning/development, regulatory/financial start-up, regulatory maintenance, and reporting from study activation to closeout.

  • RAC, CCRP, CCRC or equivalent.

  • CRS Certification required within 2 years of hire

Preferred Qualifications:

  • Master’s Degree

  • Clinical Research Experience

  • Oncology Research Experience


Additional Information:

Responsibilities:

  • Advises the PI on study and regulatory requirements.

  • Monitors and facilitates regulatory maintenance through the study approval, conduct and oversight process.

  • Interprets institutional policies related to regulatory and reporting to ensure departmental adherence.

  • Represents the department and investigators at local, regional and national meetings; facilitate effective communication among staff, PIs and other research/clinical professionals, senior leaders of UAMS, and study sponsors. Assists with development, implementation, and maintenance of quality assurance plans and develops SOPs when necessary.

  • Serve as the general administrator and liaison for the PI, research subjects, human testing compliance, privacy/HIPAA compliance, other research and clinical professionals, and the granting or funding entity relative to the research protocol.

  • Ensure strict adherence to all regulatory requirements such as the reporting of serious adverse events, modifications, etc. in the timeline required by the study sponsor and the Institutional Review Board.

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

  • Participate in the development and maintenance of electronic infrastructure and clinical trial management suite as it relates to the regulatory functions of the office. 

  • Maintains oversight of the regulatory specialists responsible for maintenance in the collection, management and reporting of all regulatory requirements. Provides staff with training and orientation to departmental policies and procedures. Monitors productivity and quality of employee efforts.

  • Conducts documented performance reviews and routine one-on-one meetings with direct reports.

  • Manages the reporting of regulatory requirements as required. 

  • May perform other duties as assigned.


Salary Information:

Commensurate with education and experience


Required Documents to Apply:

Cover Letter/Letter of Application, License or Certificate (see special instructions for submission instructions), List of three Professional References (name, email, business title), Resume


Optional Documents:

Proof of Veteran Status


Special Instructions to Applicants:


Recruitment Contact Information:

Please contact [email protected] 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:

No Background Check Required


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, Reaching, Standing, Walking


Benefits Eligible:

Yes