Data Coordinator

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This position will be responsible for the collection, validation, and entry of data using established tools, technology and databases. The Research Data Coordinator will perform data-related functions in order to support the accomplishment of the research/project objectives for a variety of clinical trials and/or studies. Coordinates and manages data registry-type clinical trials/protocols within the Department ensuring adherence to protocol requirements and regulatory guidelines. Is responsible for the collection, coordination, processing and quality control of clinical trial data. May assist with screening patients for research protocols. Obtains informed consent from subjects on data registry-type trials. Maintains research protocol information, regulatory documents and other research files as applicable. Works in compliance with principles of Good Clinical Practice and all applicable federal, state, and local regulations.

MINIMUM QUALIFICATIONS:

EDUCATION, CERTIFICATION, AND/OR LICENSURE:

1. Bachelor’s Degree.

EXPERIENCE:

1. Three (3) years’ experience in research, administrative, or clinical support.

PREFERRED QUALIFICATIONS:

EDUCATION, CERTIFICATION, AND/OR LICENSURE:

1. Obtain certification as a Research Professional through the Society of Clinical Research Associates (SoCRA) OR the Association of Clinical Research Professionals (ACRP) with three years of hire date.

EXPERIENCE:

1. Three (3) years’ experience in research or clinical support.

CORE DUTIES AND RESPONSIBILITIES: The statements described here are intended to describe the general nature of work being performed by people assigned to this position.  They are not intended to be constructed as an exhaustive list of all responsibilities and duties.  Other duties may be assigned.

1. Extrapolates data, completes case report forms, and ensures timely data submission.

2. Coordination of data registry-type clinical trials, including scheduling follow up visits and testing, assessing subject response and review of laboratory data.

3. Utilizes Clinical Trial Management System (CTMS) to access research forms and keep current all applicable patient reporting and tracking functions.

4. Consent and Assent Forms and Discussion for data registry-type clinical trials.

5. Actively prepares for and participates in monitoring and auditing activities. Assists in ensuring that all queries are resolved in a timely manner in accordance with sponsor requirements.

6. Reviews the data collection forms for completeness and reconciles missing data for data entry.

7. Collaborates with Clinical Research Specialists in screening patients for potential study enrollment for non-registry-type clinical trials.

8. Schedules study-related procedures required to maintain protocol compliance.

9. Coordinates patient follow-up visits and timely data submission.

10. Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility and provide administrative and regulatory management of protocols and clinical trials ensuring compliance with IRB, GCP guidelines and code of federal regulations.

11. Develops a mechanism for subject recruitment and ongoing communications with the PI and staff and serves as a liaison between the PI and Sponsor or Sponsor’s representative, as appropriate.

12. Collaborates with the Regulatory Coordinator on preparation for Annual Protocol Reviews and Study Summaries for submission to IRB.

13. Reviews with the PI the inclusion/exclusion criteria, overall structure, and requirements of each protocol and the protocol summary sheet and informed consent form for accuracy and clarity.

14. Reviews the protocol, informed consent form, and follow-up procedures with potential study subjects and ensures the informed consent is signed before subjects are screened and enrolled.

15. Provides quality assurance for the clinical protocols and investigations, ensuring protocol guidelines are followed.

16. Reviews the protocol, informed consent form, and follow-up procedures with potential study subjects and ensures the informed consent is signed before subjects are screened and enrolled.

17. Works collaboratively with investigators and study coordinators for study-specific training and communication related to possible or already accrued study participants.

18. Attendance of all appropriate training seminars as required by study/