JOB SUMMARY
The responsibility of a Research Assistant is to assist the Clinical
Research Coordinator in conducting clinical trials while performing a
variety of administrative and clinical study activities including
scheduling appointments, giving information to callers, screening
patients, and conducting protocol related procedures, therefore relieving
the Research Study Coordinator of clerical work and minor
administrative or clinical procedure details.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
- Provide clerical and administrative support for the Study Coordinator
- Complete organizational tools for conducting the study accurately
and in compliance with GCP, as requested - Abstract data from medical records, consultations and referral notes
to complete study forms and flow sheets - Assist in the preparation of case report forms by recording accurate
and timely data for sponsor/audit review - Keying data into data bases – each specific to individual trials
- Correct and edit CRF entries
- Resolve data queries
- Transmit data via fax, mail or electronically
- Maintain scheduling of study participants’ visits
- Assist in communication with the Sponsor regarding study activities
as necessary - To use computer applications to enhance the efficiency of workflow
and study activities - Assists in Source document preparation
- Assist Study Coordinator with recruitment materials
- Answer and screen research related telephone calls, and arrange
conference calls - Assist in preparing and submitting regulatory documents to the
sponsor, including laboratory certification, normal values,
curriculum vitae, licenses, etc - Assist in preparing and submitting regulatory documents IRB
- Maintain patient screening and enrollment logs
- Fax enrollments logs to appropriate sponsor on weekly basis
- Coordinate and arrange meetings, prepare agendas, reserve and
prepare facilities, and record and transcribe minutes of meetings - Read and route incoming mail. Locate and attach appropriate file to
correspondence to be answered by Study Coordinator - Organize and maintain file system, and file correspondence and other
records - Assist during subject visits per delegated duties (i.e. take vitals, draw
blood, perform EKG’s, perform spirometry, etc.) - Coordinate, schedule and participate in monitor visits
- Arrange and coordinate travel schedules and reservations
- Make copies of correspondence or other printed materials
- Prepare outgoing mail and correspondence, including e-mail and
faxes - Order and maintain supplies, and arrange for equipment maintenance
- Participate in educational/training activities
- Attend continuing education offerings, study meetings, educational
workshops - Assist in development of new research ideas
- Retrieve and view and/or copy charts from medical records
- Maintain a list of sponsor/CRO contacts for each protocol
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform
each essential duty satisfactorily. The requirements listed below are
representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions. - High school diploma or general education degree (GED); at least 1
year of experience in a health care environment, one to three months
research experience and/or training - Possess an in-depth knowledge of FDA guidelines, “Good Clinical
Practice” from the Code of Federal Regulations, research source
documentations and record storage - Must be motivated, organized and be able to function independently
- Neat and legible handwriting
- Ensure the availability of accurate and timely information
- Attentiveness to details
- Multi-tasking capability
- Good interpersonal, written and verbal communication skills
- Proficient PC user with excellent software user capabilities including
Microsoft Office & Excel. As well as, an accelerated aptitude for
learning new sponsor mandated programs - Ability to prioritize task directives from multiple levels of
management simultaneously - Ability to respond to common inquiries or complaints from sponsors
and monitors - Ability to work protocol required hours, including extended hours
and weekends. - Perform any other duties as assigned by management.
PHYSICAL DEMANDS
While performing the duties of this job, the employee is regularly
required to use hands and arms; stoop, kneel, crouch, or crawl. The
employee frequently is required to stand, walk, and sit. The employee
must occasionally lift and/or move up to 20 pounds.
SCHEDULE: Full Time 8:30 to 5pm; however, hours vary depending on subject
visits. Overtime shall be compensated per state law.