NCR’s
Clinical Research Coordinators: The most important persons in our
organization are the clinical research coordinators (CRC) and their research
assistants (RA). NCR has 8 CRCs and 4 RAs. Our CRCs have an average of
6 years experience in clinical research. Most are degreed RNs with practice
experience which assures knowledgeable assessment and triage of study
patients. Most CRCs have completed the certification exam. The CRC with
the support of our RAs have responsibility for study execution, data management,
and patient assessment; other employees support him or her with other
facets of the research process.
NCR’s Physician Investigators: At
NCR, physician investigators participate in the day to day execution of
protocols and assure the study patient’s safety, but do so in the
context of helping the CRC run the best study he/she can. NCR’s
full-time physician investigators (2) are board certified in internal
medicine and have 3-5 years of experience in clinical research. Because
of their hands-on approach, both physicians are knowledgeable about the
details of research protocols and study subjects and are readily accessible
to sponsors and CRAs. NCR’s collaborating physician investigators
have active practices in the Richmond area and specialize in internal
medicine/primary care, cardiology, dermatology, gastroenterology, and
obstetrics and gynecology. They assist NCR with patient recruitment, qualification,
and specialized study procedures.
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| Regulatory services: In close harmony with the CRC, a regulatory specialist executes all study-related regulatory documents within 2 working days of receipt and maintains correspondence regarding regulatory matters with the Sponsor and IRB during the study process. The regulatory specialist also manages NCR’s written standard operating procedures (SOPs) which helps us ensure compliance with GCP and ICH guidelines (as well as OSHA and HIPPA requirements). |
| Laboratory: NCR’s
laboratory specialists are responsible for obtaining and processing
all study- related samples per protocol in support of the CRC responsible for the protocol. |
| NCR’s Research
Dietitian: NCR’s full-time registered dietitians provides
nutritional counseling for lipid, weight loss, and diabetes studies and completes study-related nutritional analyzes in support of the CRC responsible for the protocol. |
| Business support:
NCR’s business office processes study agreements and budgets
within 2 working days of receipt. It tracks study progress and patient accrual through a state-of-the-art network computer system which allows resources to be allocated to CRCs as need and supports the electronic capture and transmission of research data to sponsors. |
| Patient Recruitment: NCR’s 3 full-time patient care representatives develop advertising material, conducts a phone screen of patients interested in participating in our research program, manages our research patient database, and conducts on-site screening and education classes of potential subjects. They also interact with our collaborating physician investigators to carry out chart reviews and patient qualification visits. |
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