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Experienced Clinical Research Coordinator (Phase 1 – 4)

  • Anywhere

Company :
Affinity Health

Location :
Oak Brook, Illinois

Expiry Date :
Mon, 21 Jun 2021 23:59:59 GMT

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Description :
Overview:

Affinity Health is a dedicated clinical research site with its primary location in Oak Brook, IL. The Clinical Research Coordinator manages and directs the coordination and timely handling of all components of clinical research protocols, including pre and post-research activities, in and outside of the clinical setting.

Responsibilities:

In this role you will ensure IRB approved protocols are implemented and followed; execute the informed consent process and monitor patient status and safety; collect and organize research data; schedule and conduct study-specific training and site in-services to study related staff on new or amended protocols, and educate patients and their families about treatments and possible side effects. The Clinical Research Coordinator must also be able to perform clinical tasks. CRCs typically perform tasks such as:

1. Site preparation

2. Obtaining informed consent, patient screening and recruitment

3. Patient enrollment, and conducting study visits

4. Maintaining and dispensing study product and supplies

5. Completing and ensuring the quality of case report forms

6. Maintaining source documents

7. Ensuring site quality

8. Maintain a thorough and meticulous working knowledge of protocol schemas and requirements.

9. Collaborate with physicians to maintain strict protocol adherence and serve as a resource for members of staff.

10.Writes patient information sheet for clinical studies for submission to IRB, as well as complete the necessary documents for IRB admission in a timely fashion.

11.Participate in the development and implementation of patient educational materials.

12.Writes patient information sheet (ICF) for clinical studies for admission to IRB, as well as complete the necessary documents for IRB submission in a timely fashion.

13.Review research and administrative documents to determine action items, prioritizing and tracking action items.

14.Responsible for completion, submission and tracking of regulatory documents to the IRB.

15.Respond to correspondence, data and informational requests.

Competencies:

Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others required.

Strong organizational skills required.

Strong communication skills (verbal and written) required.

Strong data management skills and attention to detail required.

Knowledge of Microsoft Word, Excel and Adobe Acrobat required.

Ability to read and understand complex documents (e.g., clinical trials) required.

Ability to handle competing demands with diplomacy and enthusiasm required.

Ability to absorb large amounts of information quickly required.

Adaptability to changing working situations and work assignments required.

Participate in the development and implementation of an internal quality assurance program for data collection, to ensure compliance with the standards of regulatory bodies (i.e. NIH, FDA, HIC).

Arrange site visits with study monitors, work independently, reviewing & responding to their concerns/comments, and implementing changes as needed.

The quality of data submitted to regulatory agencies while adhering to timelines, quality, responsiveness, and retention.

Function as Primary CRC for studies as authorized

Requirements

AT LEAST 2 years of Clinical Research Coordinator (CRC) experience or relevant experience preferred.

BS/BA required: masters in related field preferred

Strong working knowledge of Good Clinical Practice

Benefits

Full health care benefits offered