Program Manager-Clinical Research

📁
Staff
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200661 Requisition #

The Program Manager manages and oversees the administration of assigned program(s) for the School of Medicine-Clinical Research. The program(s) may be scientific, research, educational, or service oriented. Duties for this role will include:

•Assist students, residents, fellows, faculty and non-faculty in developing Investigator initiated research projects, especially by providing guidance on the research approval process.
•Facilitate researchers/faculty in getting access to bio statistical analysis/data collection
•Prepare and submit investigator (student, resident, fellow, faculty, non-faculty) initiated protocols and study related materials to Institutional Review Board (IRB).
•Maintain paper and electronic study documents, manage files, and provide written communication to faculty investigators to facilitate research performed at Creighton University
•Proofread/edit/and provide grant writing assistance including of multidisciplinary proposals. Edit draft proposals to create highly competitive submissions and review proposal feedback for potential resubmission opportunities and/or submission to other grant agencies
•Ability to translate complex scientific information into practical communications
•Connect scientists to resources; routinely searches database for funding opportunities especially on a governmental level.
•Facilitate collaboration among researchers within the institution and to community-based research initiatives.
•Track and coordinate participation in ongoing funding opportunities.
•Assist various department staff in writing periodic reports to comply with grant requirements
•Prepare documents and data for clinical trials according to federal law, study sponsor guidelines and IRB requirements.
•Coordinate annual renewal applications, protocol amendments, and prepare expedited IRB notification of protocol violations
•Facilitate regulatory monitoring visits with sponsor CRAs
• Ability to be back up for other program coordinator(s).


This position will work Monday to Friday; 8am-4:30pm; depending upon research needs position may require evening, weekend, and holiday work.

This position will also work out of CHI/Bergan Mercy Hospital (7500 Mercy Rd., Omaha, NE) so may require additional compliance requirements as a non-CHI member.



Qualifications:
Bachelor's Degree required; Masters preferred;
5 year's related experience with a minimum of 2 years IRB submission background and understanding of the different types of research;
Knowledge of Federal Research Regulation;
Proficiency skills in MS Office Suite to include Word, Excel, PowerPoint and Outlook

 

Knowledge, Skills, Abilities:
Knowledgeable in preparing documents and data for clinical trials according to federal law, study sponsor guidelines and IRB requirements;
Excellent verbal and written communication skills required
Organizational skills;
Analytical skills required;
Strong collaborative/teamwork ability to motivate, and inspire diverse staff at all levels of the organization;
Results oriented;
Mission and Service oriented

Physical Requirements:
Seeing: 75 – 100%
Hearing: 75-100%
Standing/Climbing/Mobility: 0-24%
Lifting/Pulling/Pushing: 0-24% (pound: 15 lbs.)
Fingering/Grasping/Feeling: 75-100%
Travel: 0-24%
Exposure to Blood Borne pathogens: No
Working with Animals: No

AAP/EEO Statement:
Creighton University is committed to providing a safe and non-discriminatory educational and employment environment. The University admits qualified students, hires qualified employees and accepts patients for treatment without regard to race, color, religion, sex, marital status, national origin, age, disability, citizenship, sexual orientation, gender identity, gender expression, veteran status, or other status protected by law. Its education and employment policies, scholarship and loan programs, and other programs and activities, are administered without unlawful discrimination.

Disclosure Statement:
This description describes the general nature of work to be performed and does not include an exhaustive list of all duties, skills, or abilities required. Regular, reliable attendance is an essential function and all employees are required to follow any other job-related instructions and to perform any other job-related duties as requested by their supervisor. Employees may also be required to work in excess of normal working hours as workloads and seasonal activities necessitate. A complete description is available in the Human Resource office located at 3006 Webster Street Omaha, NE. Creighton University reserves the right to modify duties, responsibilities and activities at any time with or without notice.

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