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Company Overview 

The nonprofit concept is the cornerstone of the philosophy of Dialysis Clinic, Inc. The Corporation was conceived in 1971 by a group of university-based nephrologists in Nashville, Tennessee, in response to the scarcity of available dialysis services in the area. DCI represents a viable alternative to for-profit dialysis organizations. The rehabilitation of ESRD patients, along with the constant improvement of their care, is of paramount concern to DCI and will continue to be the principal thrust of our efforts.

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NURSE - Clinical Research Coordinator    Apply for this job now!
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Job Description 

Clinical Research Coordinators provide support, coordination and leadership for drug/device studies that may involve industry-sponsored Phase I, II, III, and IV clinical trials; government-funded clinical research, and investigator-initiated clinical research (collectively referred to as “clinical research involving human subjects").  They ensure smooth, accurate progress of clinical studies from the planning and approval stages through study completion and post-study closure.  They prepare documentation for submission for review by the Institutional Review Board (IRB),  recruit and screen study participants, schedule clinical treatment and follow-up care, and facilitate patient’s continued participation; abstract data from medical records and other sources; collect, submit and maintain study data and regulatory documents, and ensure compliance with study protocols in order to provide consistent and quality data.  Provide superior healthcare utilizing medical knowledge and clinical skills throughout each clinical trial.

 

RESPONSIBILITIES:

1) Ensure compliance with the clinical trial protocol and overall objectives of the study including the collection, preparation, maintenance, and submission of numerous study documents (Institutional Review Board (IRB) applications, CV's, medical licenses, case report form(s), regulatory documents binder, electronic data capture, etc.) as applicable.

2) Specific job responsibilities may include but are not limited to:

a.  recruit and interview patients for study eligibility and enrollment.

b.  manage informed consent process and ensure confidentiality practices are consistent with regulatory and study guidelines. 

c.  maintain a strong relationship with subjects involved in clinical trials and ensure that their rights as subjects are protected.

d.  coordinate study visits of study subjects.

e.  perform study procedures (vital signs, EKG's, BIA, medical history, lab procedures, etc.) per qualification.

f .  log and inform Principle Investigator (PI) of any possible adverse reactions or serious adverse events.

g . maintain study logs, IRB forms and Regulatory Binders for each clinical trial.

h.  maintain a strong relationship with investigators; their staff members and entities        representing the interests of professionals participating in trials.

i.   participate in routine monitoring visits from Sponsor and/or FDA audits.

j.   conduct clinical trials in 2 or more outpatient dialysis units as needed.

k.  be able to coordinate multiple trials.

 

 


Job Requirements 

PREFERRED QUALIFICATIONS:

1) RN experienced in conducting industry sponsored clinical trials on a full time basis.

2) RN with certification as a CCRC or CCRA.

MINIMUM QUALIFICATIONS:

1)  LPN, RN or RD in good standing with a minimum of 1 year of full time experience coordinating industry sponsored clinical trials as a Clinical Research Coordinator (OR) RN with at least 2 years of  clinical experience.

2)  Must be CPR certified.

3)  Must have reliable transportation, a valid driver’s license, auto insurance, and be willing to travel to multiple DCI clinics within a given territory.

4)  Must be flexible with work schedule to accommodate study visits as needed.

5)  Must be willing to travel overnight for Investigator Meetings as required.

6)  Must be able to work independently with limited supervision.

7)  Must be organized and detail oriented.

8)  Must have strong written and verbal communication skills.

9)  Must be able to maintain and follow up with all documentation involved in coordinating a clinical trial and/or multiple clinical trials.

10)  Must be proficient using electronic medical records systems.

11)  Must be familiar with and knowledgeable about using computer programs such as word processing software and spreadsheet applications.

12)  Physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear.  The employee is occasionally required to stand or walk.  The employee must regularly lift and/or move up to 10 pounds, rarely lift and/or move up to 25 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

 

 

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