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Clinical Research Coordinator

IACT Health


Location:
Lawrenceville, Georgia
Date:
04/25/2017
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Clinical Operations
IACT Health
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  • Research Salary

Job Details

GENERAL JOB DESCRIPTION:

1. Oversee subject randomization for clinical trials and completion of required documentation. 

2. Ensure quality assurance (QA) of data integrity. 

3. Provide Sponsor, CRO and other industry representatives with usable data by converting subject’s source documentation into Case Report Forms (CRF).

4. Coordinate and resolve all inquiries and problems associated with data submissions.

5. Thoroughly prepare for all Sponsor, CRO, and FDA visits. This includes PSVs, SIVs, IMVs, COVs, and audits of all types.

a. Ensure understanding of the operations of the clinic and clinical staff for PSV tours.

b. Ensure that the trial Regulatory binders are updated with all filing, that all CVs and licenses are current, and that all logs are updated.

c. Ensure that the Subject binders are updated with all filing and that all drug accountability, concomitant medication, adverse events, and other logs are updated.

d. Perform a thorough quality assurance review on each Subject chart. As much as possible, remedy issues prior to the visit.

e. Ensure that all Pharmacy binders are updated with filing, that all lab certifications are current, and that all drug accountability logs are updated.

f. Ensure cleanliness of the clinic and the room that the monitor/auditor will be using prior to each visit.

6. Serve as central point of contact for all clinical trial close-out visits.

7. Display basic understanding of GCP/ICH Guidelines.

a. Learn to locate available information and resources, both from internal and external sources. b. Learn to find solutions to problems using creativity and critical thinking skills.

8. Participate in the On-Call schedule for the Site.

9. Display a high level of effort and commitment to performing work; operate effectively within the organizational structure; demonstrate trustworthiness and responsible behavior.

a. Demonstrate eagerness to learn and assume responsibility; seek out and accept increased responsibility; display a “can do” approach to work.

b. Show persistence and seek alternatives when obstacles arise; seek alternative solutions; do things before being asked or forced to by events.

c. Work within the system in a resourceful manner to accomplish reasonable work goals; show flexibility in response to process change and adapt to and accommodate new methods and procedures.

d. Accept direction and feedback from colleagues and supervisors and follow through appropriately.

10. Demonstrate professional flexibility and ability to multitask.

a. Set priorities and remain organized.

b. Manage multiple assignments and adapt to changing assignments.

c. Demonstrate self-direction by setting and reaching goals without continual supervision.

11. Skilled in the use of computer project software.

 

 Knowledge, Skills, & Abilities:

Demonstrate ability to maintain professional standards. Set priorities. Identify and resolve problems effectively and efficiently. Possess excellent communication and organizational skills for managing workflow and follow-up. Demonstrate ability to anticipate the needs of patients, staff, and physicians.

Demonstrate reliability and maintain confidentiality. Possess temperament and emotional intelligence for dealing with others professionally. Demonstrate ability to maintain excellent patient and staff satisfaction evaluations. Possess excellent dialogue skills to communicate clearly and effectively with patients, physicians, industry professionals, and others in person, over the phone, or via email. Demonstrate ability to accept delegation of tasks and execute in a timely manner. Demonstrate ability to be a positive role model for office staff, physicians, and others.

Requirements

QUALIFICATIONS

• High school Diploma or GED.

• 1 year of clinical research experience in Oncology preferred.

• Up to date nursing skills to include: venipuncture, IV certification, BLS/CPR certification or capability of learning these skills.

CHARACTERISTICS

• Outstanding attention to detail • Highly organized • Enjoys patient care • Understands protocols • Pleasant/Friendly Demeanor • Empathetic • Can Do attitude • People person • Ability to Follow Directions • Nursing Skills • Knowledgeable in Medicine

LOCATIONS

This job is open at the following locations:

GA

Columbus Regional Research Institute (CRRI)- 800 TALBOTTON RD - COLUMBUS, GA, 31904

Gwinnett Biomedical Research (GBR)- 555 Old Norcross Rd 555 Old Norcross Rd, Suite 250- Lawrenceville, GA, 30046