CLINICAL RESEARCH COORDINATOR "OPHTHALMIC"

Location
Durham, NC
Posted
Jun 13, 2017
Institution Type
Four-Year Institution

diversity employer



CLINICAL RESEARCH COORDINATOR "OPHTHALMIC"
Ophthalmology-General

UPDATED 5/15/17

Occupational Summary:
This is a position for a clinical research coordinator (CRC) in the Duke Eye Center / Department of Ophthalmology. The hired CRC will oversee a portfolio of clinical research studies conducted by faculty investigators within the Cornea Division. Studies will include but not necessarily be limited to investigator-initiated grant-funded research, federally funded clinical research projects, and industry-sponsored clinical trials, all of which will be performed within the Ophthalmology Clinical Research Unit. This CRC position will have a variety of specific duties and responsibilities, including the day-to-day administration of studies, collection and compilation of study records, documentation and analysis of collected data, and regulatory oversight of study conduct and assuring compliance with good clinical practice guidelines, federal regulations, and institutional policies. Day-to-day study activities of this CRC will be overseen by faculty investigators of the Cornea Division, while regulatory compliance activities will be managed by the Research Practice Manager of the Ophthalmology Clinical Research Unit.

Knowledge/Skills/Abilities (Preferred)
  • Ideal candidate will have prior working in clinical research, with a specific emphasis on project management, either as a clinical research coordinator or regulatory coordinator.
  • Professional clinical research certification (ACRA or SoCRA) is desirable but not required.
  • Prior experience within ophthalmology, or prior ophthalmic technician training / certification is NOT required.
Work Performed
  • Follow established guidelines in the collection of clinical data and/or administration of clinical studies.
  • Confer with study participants to explain purpose of study and obtain informed consent; explain diagnostic procedures and/or treatment plans to alleviate patient and/or family concerns; schedule patient for study procedures; initiate/coordinate drug orders, laboratory procedures and treatments for patients based on standing protocol orders.
  • Answer a range of questions on disease and treatment options.
  • Reconciliation of weekly/monthly finance documents.
  • Maintain subject registries and other documentation of screened and/or enrolled subjects.
  • Perform IRB submissions as well as all Sponsor/regulatory agency requested submissions.
  • Collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation; obtain blood samples, cultures, tissues and other specimens for laboratory analysis.
  • Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and monitor patient's progress to include documentation and reporting of adverse events; recommend corrective actions as appropriate.
  • Evaluate and interpret collected clinical data in conjunction with study investigator(s) as appropriate; prepare oral presentation or written reports and analyses setting forth progress, trends and appropriate recommendations or conclusions.
  • Confer with principal investigator(s) in developing plans for research projects and to discuss the interpretation of results; collaborate on the preparation of manuscripts for publication.
  • Coordinate the development of forms, questionnaires and the application of research techniques; write procedures manuals for data collection and coding.
  • Review journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.
  • Perform other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.



Requisition Number
401203634

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1201 CLINICAL RESEARCH COORDINATOR

Job Family Level
52

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender identity, national origin, race, religion, sexual orientation, or veteran status.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Education

1.Completion of a Bachelor's degree
2.Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination)

Auto req ID

85612BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

PI98156539