Clinical Research Assistant
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Division: Administrative Services
Department: Health Systems
Supervised By: Director of Health Systems
FLSA Status: Non-exempt/Regular/.50%
Effective Date: July 2013
Under general supervision, this position will assist in the conduct and implementation of clinical trials research. Serve as front-line contact for the research center and provide support to research staff. Participate in the recruiting, screening, initiation, monitoring, completion, and reporting of routine moderately complex studies in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP).
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Maintain high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conference, seminars and team meetings.
- Assist development/implementation of SOP to ensure adherence to trial protocols, regulatory and administrative requirements.
- Conduct telephone screens with potential subjects, as well as follow-up contacts.
- Access/pre-review medical records for study inclusion.
- Design study related forms according to trial protocols.
- Collect, process and assist in compilation/verification of research data, samples, and/or specimens (following strict protocol)
- Enter data from forms/documents into databases and other documents.
- DAILY insure that all required data is documented, including all required signatures and dates.
- Assist with routine data verification/quality control, ensuring data integrity and consistency with prescribed study protocol, including shipment of samples.
- Perform literature searches, research and overall administrative assistance.
- Schedule/coordinate study-related appointments for subjects, staff meetings/appointments/training sessions, and monitor/auditor visits.
- Assist in setup, operation and maintenance of research equipment/instruments meeting quality control standards.
- Assist to recruit subjects for trials subjects and developing tools to improve clinical trial conduct.
- Insure all study supplies/equipment is received and stored properly; all unused supplies/equipment returned at end of study.
- Develop credible relationships with subjects and customers.
- Performs other duties as assigned.
- Minimum 2 years experience in clinical trials research required.
- Associate Degree required in health/medical field. Bachelors Degree in health/medical field or RN with clinical trials experience preferred.
- PREFERRED QUALIFICATIONS:
- Outstanding technical writing skills/understanding of medical terminology/research.
- Exceptional organizational, interpersonal, and presentation skills.
- Ability to understand and follow complex, detailed technical instructions.
- Ability to foster a cooperative work environment.
- Ability to maintain quality, safety, and/or infection control standards.
- Ability to understand and follow basic scientific research protocol/procedures.
- Highly proficient with MS Office, and research-related software/computerized systems/databases.
- Advanced understanding of data management/computerized syst.
- Ability to analyze/interpret scientific/medical data
- Ability to work flexible schedule as outlined in job description
- Maintain at least minimum required continuing education units per year in topics approved by supervisor.
- Reliable transportation required and willingness to use in work capacity.
- Daytime traveling required, infrequent overnight traveling.
Certificates, Licenses, Registrations
- SOCRA membership and all CITI online training certification.
- Current clinical research certification, i.e. SOCRA or ACRP; or achieve certification after 3 years.
- Valid Indiana driver's license.
- Current CPR/First Aid certification.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Routine light lifting and transport (under 30 pounds).
- Prolonged periods of sitting and/or standing.
- Prolonged periods of data entry, handwriting, driving vehicle.
Work is primarily performed in offices or other HCI consumer locations. Daytime traveling required. Attention to use of Universal Precautions required due to work related activities.
Conditions of Employment
- Completion of tuberculin screening no later than three days prior to first day of employment and annually thereafter
- Completion of a pre-employment drug screening and completion of post-employment drug or alcohol tests upon reasonable suspicion of use.
- Completion of Center-wide orientation and ALL required paperwork prior to reporting for work
- Demonstrated computer literacy through successful completion of pre-employment testing may be required.
- Completion of HCI Quality training
- Attendance at all mandatory staff development and training
- Successful completion of a six month on the job orientation period
- Participation in payroll electronic deposit
- Adherence to Compliance Program Plan
- Satisfactory reference and background investigation checks.
Job descriptions are not intended, and should not be construed, to be exhaustive lists of all responsibilities, skills, efforts or working conditions associated with a job. They are meant to be accurate reflections of the principle job elements essential for making fair pay decisions about jobs.