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Clinical Trials Research Assistant
$50k-66k (estimate)
Full Time | Ambulatory Healthcare Services 7 Months Ago
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The University of Iowa is Hiring a Clinical Trials Research Assistant Near Iowa, IA

The University of Iowa Carver College of Medicine department of Dermatology is seeking a Clinical Trials Research Assistant to support, conduct and manage clinical trials to deliver and evaluate research protocols. Key areas of responsibility include protocol development/management and study responsibilities; research/clinical activities, subject recruitment and enrollment, data collection and monitoring; regulatory guidelines and documents and financial responsibility.
  • Prepare regulatory documents for sponsor approval.
  • Prepare IRB documents for protocol approval.
  • Research, change, and submit protocol amendments for IRB approval.
  • Submit protocol data, yearly renewals, and study modifications to the IRB in a timely fashion.
  • Monitor protocol status as it is process through the IRB.
  • Submit applications to the CRU for clinical studies that will utilize their services.
  • Communicate to sponsors.
  • Manage and maintain protocols.
  • Monitor visit reports for all studies.
  • Responsible for conducting training of new protocols and changes to existing protocols.
  • Responsible for site management and daily activities associated with a clinical trial; respond to clinical site monitoring questions regarding data collection and data entry issues.
  • Participate in clinical research visits, which may include Epic documentation, checking vitals and drawing blood.
  • Consult with researchers to assist in development of data management plans; design forms to facilitate the collection and tracking of study participant data, study drugs, biological specimens and study procedures.
  • Assist in the design, development, execution, administration and maintenance of protocols and clinical studies.
  • Assist with clinical and data coordination for research activities and set up supplies for study visits.
  • May assist with subject recruitment by mining databases and EPIC.
  • May assist with subject recruitment by recruiting subjects from the providers clinics in the Dermatology Clinic.
  • May complete telephone screening of potential subjects to determine initial eligibility for enrollment.
  • Manage and organize regulatory documentation from sites and regulatory authorities.
  • Monitor compliance of regulatory guidelines and proper maintenance of documents.
  • Complete regulatory submission and close out process.
The Roy J. and Lucille A. Carver College of Medicine is a highly ranked medical school where students learn to become accomplished clinicians and top-flight researchers and educators. Students come to Iowa to study medicine in a program that uses case-based learning as the basis of their education. With its emphasis on problem-solving skills, early exposure to patients, and enhanced community-based experiences, UI medical students typically earn impressive scores on Step 1 of the U.S. Medical Licensing Examination and successfully “match” with top-quality residency programs around the country.
Percent of Time: 100%
Salary: 3A
Benefits Highlights:
  • Regular salaried position located in Iowa City, Iowa
  • Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans
  • For more information about Why Iowa?, click here
  • The University of Iowa offers a generous benefits package, including 24 days paid vacation per year to start and paid sick leave. Complete information regarding the full benefits package may be viewed at: https://hr.uiowa.edu/benefits/fpsm.
Required Qualifications
  • A Bachelor of Science degree or an equivalent combination of education and experience.
  • 6 months to 1 year of related experience
  • Excellent written and verbal communication skills
  • Experience with preparation of IRB or regulatory submissions
  • Proficiency in computer software applications (MS Word, Excel, Outlook and PowerPoint)
Desirable Qualifications
  • Experience with RedCap database is desirable
  • Experience with Epic is desirable
  • Experience with following specific protocol techniques and management is desirable
  • Basic experience and participation with clinical trials is desirable
  • Certification that allows for blood draw (Phlebotomy Technician, Certified Medical Assistant, LPN, RN) is desirable
Application Process: In order to be considered, applicants must upload a resume and 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.

Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification.

This position is not eligible for University sponsorship for employment authorization.

With additional question, please reach out to Adam Santi at adam-santi@uiowa.edu

Job Summary

JOB TYPE

Full Time

INDUSTRY

Ambulatory Healthcare Services

SALARY

$50k-66k (estimate)

POST DATE

02/23/2023

EXPIRATION DATE

10/26/2024

WEBSITE

uiowa.edu

HEADQUARTERS

COUNCIL BLUFFS, IA

SIZE

7,500 - 15,000

FOUNDED

1847

TYPE

Private

CEO

KRISTA SMITH

REVENUE

$3B - $5B

INDUSTRY

Ambulatory Healthcare Services

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