Regional Clinical Research Associate
Job Code: 0328
Approximately 2-5 years monitoring experience
Under general supervision, the Clinical Research Associate (CRA) will assist
with coordination of clinical studies within the Clinical Research
Operations area. A CRA is expected to demonstrate initiative and originality
in organizing, systematizing and coordinating clinical research activities.
Primary Responsibilities to include:
- Demonstrate superior communication and organizational skills in
addition to the technical skills required for overseeing clinical
studies.
- Recognize the urgency of meeting established schedules and be able
to prioritize tasks and time to meet those schedules.
- Help identify and select trial sites. Conduct qualification,
initiation, interim monitoring close-out visits, and perform drug
accountability (approximately 50% travel required).
- Ensure the timely collection of appropriate regulatory documents
from study sites.
- Assist in the development of materials that support the conduct of
clinical studies including: site reference manuals, monitoring flow
sheets, CRF completion guidelines, etc.)
- Review clinical documents for accuracy and completion (1572,
consents, protocols, meeting minutes, etc).
- Assist in the preparation of investigator’s meetings.
- Remain current with applicable regulations concerning development
and conduct of human clinical trials (CFRs, ICH). Communicate to
investigators the rudiments of GCP and their related responsibilities.
- Demonstrate working knowledge of relevant clinical trial SOPs.
- Ensure assigned studies adhere to approved protocols.
- Maintain a level of accuracy that minimizes data query rate and
ensures data are accurately transcribed to meet SOP and audit
expectations. Identify and provide solutions for data trends.
Requirements
- Have a fundamental understanding of clinical research.
- Have a working knowledge of the relevant SOPs.
- Have the necessary interpersonal and communication skills to
establish professional working relationships with colleagues and site
personnel.
- MS Word, Excel, in-depth knowledge of other presentation programs a
plus.
- Minimum BA or BS degree with 1+ years in a clinical research
environment.
- Strong, organizational planning and follow-through skills.
- Excellent language and grammar skills, ability to write clearly and
concisely.
- Attention to detail and the ability to prioritize.
- Ability to work well under pressure and with tight schedules.
- Ability to plan and schedule workload and work effectively with
others.
- Ability to exercise judgment within generally defined practices and
policies for obtaining data.
- Self-direction and motivation are mandatory.
- Ability to resolve problems positively and professionally.
Availability
- Must have the quality-service attitude and be willing to work
additional hours to meet deadlines
- Required to make site visits (approximately 50% overnight travel
required)
Salary and Benefits
Salary commensurate with experience. Benefits Program including health,
dental, vision, life, AD&D and long-term disability, 401K with Company
matching.
Position Type: Full-Time, Employee
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