Catholic Health Initiatives Institutional Review Board Coordinator - Medical Education - 0.8 PT Days in DES MOINES, Iowa

Institutional Review Board Coordinator - Medical Education - 0.8 PT Days

Description

GENERAL SUMMARY :

Coordinate

functions of the Institutional Review Board to facilitate the achievement of

its research goals. Perform

administrative activities related to clinical research regulatory process to

assure quality interactions with the Institutional Review Board members, primary

Investigators, and research staff.

ESSENTIAL FUNCTIONS :

  • Promote functions of the IRB bydemonstrating excellent managerial and organizational skills.

  • Ensures IRB compliancewith all federal, state, and local guidelines by implementing policies andprocedures related to the protection of rights and welfare of humansubjects.

  • Works effectively and facilitatescommunication with investigators, committee members, IRB chair, and federalregulatory agencies.

  • Provides guidance toresearch staff on submission of protocols, annual review procedure,adverse event reporting to be in compliance with regulations.

  • Screens protocols attime of submission to evaluate if they meet criteria for exempt orexpedited review.

  • Demonstrates theability to work independently and displays strong interpersonal skills.

  • Arrange and coordinateall aspects of the IRB meetings, records, and communications. Attend, as ex-officio member, allmeetings of the IRB. Prepare anddistribute an agenda indicating the protocols to be discussed before eachscheduled meeting. Record anddistribute minutes of the IRB meetings that record the attendance andactions of the IRB.

  • Monitors program bytracking pending submissions and advising investigators regardingsubmission status and providing them with the review process andinterpretation of committee guidelines.

  • Ensures correctdocumentation by reviewing IRB submissions (application, protocol, andconsent form) for accuracy and clarity prior to their review by the fullcommittee.

  • Supports the committeeby maintaining database for over 150 research protocols.

  • Maintains IRB Policyand Procedure manual and submits revisions to IRB as indicated.

  • Prepares all seriousadverse event and INDsafety letter spreadsheet for review by the IRB.

  • Responsible formaintenance of regulatory binders for each individual protocol (filing allapproval letters, all stamped consents, copies of all communications withthe IRB both incoming and outgoing, all sponsor communications, allcontinuing progress reports and all SAE reports or IND safety lettersubmissions to the IRB. Ensuresthat each regulatory binder is organized, complete, and ready forinspection/audit at any time.

  • Provides consultation andacts as a resource to review human research projects forinvestigators. Works closely withresearch faculty and staff to ensure that all study related regulatoryrequirements are met.

  • Assist in thedevelopment of materials for the orientation and continuing education ofIRB members and alternates.

  • Analyze opportunitiesto improve services and implement enhancements.

  • Promotes departmentfunction by keeping abreast of mandates, research issues, and financial resources.

  • Enhances personalperformance development by attending conferences and meetings forcontinued education on current IRB issues and matters, including but notlimited to: Public Responsibilityin Medicine and Research (IPRIMR), Applied Research and Ethics NationalAssociation (ARENA), the Office of Human Research Protections (OHRP), andthe Food and Drug Administration (FDA).

  • Oversees financialresources by maintaining an IRB invoice billing system of new protocols.

  • Computer requirementsfor closure of studies and archiving of documentation for six years.

  • Promotes officefunctionality by prioritizing workload and handling changing workassignments.

  • Exhibits superior workskills by handling large volumes of work with frequent interruptions.

  • Ensures positivecollaborative efforts by working both independently and with a team.

  • Protects patients,staff, and hospital by maintaining strict confidentiality.

  • Performs dutieseffectively by applying principles of logical and/or scientific thinkingto a wide range of intellectual and practical problems.

  • Exhibits tact and skillby dealing with new situations and seeking appropriate supervision.

Qualifications

MINIMUM KNOWLEDGE, SKILLS,AND ABILITIES REQUIRED :

  • High school diploma orGED required.

  • Two-years experience ina health related field, preferably supporting clinical research.

  • Prefer Certification asClinical Research Coordinator by nationally recognized body.

  • Knowledge of PCsrequired. Experience with Windowsincluding Word, Excel, and Outlook.

Job Professional Non-Clinical

Primary Location IOWA-DES MOINES-MERCY MEDICAL CENTER

Daily Schedule Day Shift

Scheduled Hours per 2-week Pay Period 64

Weekends Required None

Req ID: 2018-R0165972

We’re an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.