Clinical Research Coordinator II

Job Profile Summary

This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes .

In addition, this role focuses on performing the following Research Programs and Projects duties : Supports the development of new products and innovation.

Includes Clinical roles focused on research projects. Positions in this family perform basic, translational, and / or clinical research towards solving a specific problem for an entity or community.

A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs .

The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education .

An entry level role that applies broad theoretical job knowledge typically obtained through advanced education . May require the following proficiency : work is closely supervised, problems faced are not typically difficult or complex, and explains facts, policies and practices related to job area.

Job Overview

This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned.

Job Description

Minimum Qualifications :

1. Bachelor’s degree OR High School Diploma or equivalent AND Four (4) years of related experience.

2. Basic Life Support (BLS) certification may be required based on specific role requirements.

3. Two (2) years in research related activities.

Preferred Qualifications :

1. Five (5) years in research related activities.

2. Previous experience in clinical trials.

3. IATA Hazardous Good Shipping certification.

4. CITI Human Research Protection certification.

Duties and Responsibilities : The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list .

Other duties and responsibilities may be assigned.

1 . Responsible for assisting in the recruitment of study participants.

2. Organizes strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings as required .

3. Completes follow up with study participants in prescribed settings as required .

4. Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods.

5. Complies with all institutional policies and government regulations pertaining to human subjects’ protections.

6. Responsible for assisting with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews.

7. Performs basic laboratory activities as needed.

8. Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.

9. Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.

10. Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.

11. Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests, etc.

12. Organizes and participates in site visits with the study sponsor to review completeness and accuracy of study documentation.

13. Maintains inventory of all study supplies.

14. Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements.

15. Reviews all eligibility and ineligibility criteria in the patient’s record.

16. Verifies information with the physician. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.

17. Conduct s a QC check of completed CRFs prior to submission for data entry .

18. C oordinat es resolution of all data queries.

19. Complet es data entry as warranted .

20. Maintains regulatory binders, case report forms, source documents, and other study documents.

21. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board.

Physical Requirements :

1. Typical clinical and administrative office setting.

Skills & Abilities :

1. High degree of organizational talents, data collection and analysis skills.

2. Requires meticulous attention to detail.

3. Excellent computer skills including word processing .

4. Ability to prioritize quickly and appropriately .

5. Excellent communication and interpersonal skills .

6. S ystematic record-keeping .