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Holden Comprehensive Cancer Center Clinical Trials Rsrch Data Manager

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Research
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19004697 Requisition #

The Holden Comprehensive Cancer Center (HCCC) at the University of Iowa is seeking a Clinical Trials Data Manager to serves as a member of the Clinical Research Services (CRS) team and assists in the planning, delivery and evaluation of health care provided to research protocol patients; works closely with Clinical Research Coordinators in the collection of data and in close collaboration with multiple departments and offices, including the University Clinical Trials Office; maintains medical documentation, binders and files; manage data entry and electronic data systems for clinical research protocols;  performs labs procedures for clinical trials currently being conducted within the Holden Comprehensive Cancer Center (HCCC) at The University of Iowa. 


Duties Include:

·        Functions as a member of the Clinical Research Services team to plan, prioritize, deliver, and evaluate the health care provided to research protocol patients.

·        Prepare, retrieve, store, and ship laboratory specimens and other diagnostic test results.

·        Creates, populates, maintains, and enhances multiple databases containing clinical and research information obtained through review of patient charts and samples, lab reports and other related information and in a manner that complies with Institutional Review Board requirements and in response to physician and research needs and requirements.

·        Assists in the design, development, execution and administration of data entry for protocols and clinical studies.

·        Follows study participants; manages collection of data including maintaining records of patient visits/interviews.

·        Enters protocol patient data on electronic databases ensuring that all prerequisites have been completed and are within the required parameters.

·        Assists in the preparation of research study charts for periodic review by both internal and external monitors.  Assist in follow up of any queries identified in the review.

·        Assists in obtaining and delivering prescription medications from investigational pharmacy.

·        Monitors compliance, gathers and maintains data for pharmaceutical sponsored research trials, in-house trials and cooperative group studies; creates worksheets, treatment flow sheets and assorted tools to provide source documentation of protocol treatment procedures provides follow-up for treatment related complications.

·        Serves as liaison to local physicians/hospitals to facilitate care of protocol patients when hospitalized at outside institutions; obtains documentation of the hospitalizations; provides notification to the Principal Investigator, Study Sponsor, and FDA as required per protocol.

·        Assists in judging validity of data; makes recommendations for change as opportunities for improvement are identified in close collaboration with the clinical research coordinator.

·        Assists in maintaining documentation of protocols and relevant data, follow-up correspondence, and summaries.

·        Assists study coordinators in preparing data summaries and other information for use by faculty and staff in the preparation of reports, publications, manuscripts, research papers, grant funding proposals and presentations.

·        Participates in the development of general goals for the Clinical Research Service office.

·        Attends protocol meetings and other UIHC and Study Sponsor meetings; participates on committees as appropriate.

 

The information contained herein is not intended to be an exhaustive list of all responsibilities required of individuals performing this job.

 

 

University of Iowa Hospitals & Clinics—recognized as one of the best hospitals in the United States—is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives.®

 

Percent of Time: 100%

Schedule: Monday through Friday, 8:00 AM to 5:00 PM


REQUIRED QUALIFICATIONS:

1.      Bachelor’s degree or an equivalent combination of education and experience.

2.      6 months to 1 year experience in a health care setting.

3.      Experience with medical terminology.

4.      Excellent verbal, written and interpersonal communication skills.

5.      Proficient in computer software applications.

6.      Ability to manage complex information with attention to detail and a high level of accuracy.


HIGHLY DESIRED QUALIFICATIONS:

1.      Relevant experience in the conduct of clinical or laboratory research studies.

2.      Knowledge of regulatory guidelines and procedures.

3.      Clinical Research Coordinator Certification (SOCRA or ACRP).

 

DESIRED QUALIFICATIONS:

1. Knowledge of University of Iowa policies, procedures and regulations.

 

 

Application Process: In order to be considered, applicants must upload a resume and a cover letter (under submission relevant materials) that clearly address how they meet the listed required and desired qualifications of this position.

 

Job openings are posted for a minimum of 14 calendar days. Applications will be accepted until position is filled.

 

Successful candidates will be subject to a criminal background check.


Equal opportunity/affirmative action employer


The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran.


Persons with disabilities who need assistance or accommodations with the application or interview process may contact University Human Resources/Faculty and Staff Disability Services, (319) 335-2660 or fsds@uiowa.edu.  For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at 319-356-7543.

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