Clinical Research Associate Gerontology

JOB SUMMARY

Participates in large scale and/or multiple protocol clinical research studies conducted by the principal investigator(s) at Wake Forest University School of Medicine. Coordinates and participates in a variety of activities involved in the collection compilation documentation of clinical research data.

EDUCATION/EXPERIENCE

Bachelors degree in Education Public Health Basic Science or a relevant clinical discipline with three years of survey research experience including interviewing and supervision of data collection; or an equivalent combination of education and experience.

LICENSURE CERTIFICATION and/or REGISTRATION

Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professional (ACRP) certification required.

ESSENTIAL FUNCTIONS

1. Participates in clinical research studies conducted by the principal investigator(s) at Wake Forest University School of Medicine. Performs variety of activities involved in the collection compilation documentation and analysis of clinical research data.
2. Follows established guidelines in collection of clinical data and/or administration of clinical studies.
3. Participates in procedures to collect patient data for use in clinical research studies including consenting implementing procedures and/or treatment plans to alleviate patients concerns under the direction of the RAII. Schedules patients for study procedures; initiate/coordinate drug orders laboratory procedures and treatments for patient based on standing protocol orders. Collects data from patients charts medical records interviews questionnaires diagnostic test and other sources; evaluate and interpret collected data and prepare appropriate documentation; obtain samples specific to therapeutic area for laboratory analysis and review.
4. Ensures compliance with protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and monitor patients progress to include documentation and reporting of adverse events; recommend corrective actions as appropriate.
5. Assists with development of collection methods. Creates and revises study materials forms manuals and brochures as requested.
6. Evaluates and interprets collected clinical data in conjunction with principal investigator(s) as appropriate.
7. Orders and maintains adequate supplies for the project.
8. Establishes and maintains separate billing files on specific accounts related to individual departments/sections during the course of the project.
9. Provides guidance to lower level personnel involved in implementation clinical studies.
10. Reviews journals abstracts and scientific literature to keep abreast of new developments in assigned therapeutic area.
11. Performs other duties as assigned by management.

SKILLS/QUALIFICATIONS

• Knowledge of computerized data processing
• Proficiency in Microsoft Office applications
• Ability to prioritize and organize a high volume workload and changing priorities
• Familiar with principles of protocol development study design statistics and IRB process
• Ability to direct the work of others
• Ability to maintain patient confidentiality and comply with HIPAA regulations

WORK ENVIRONMENT

• An indoor clinical research setting
• Exposure to human bodily fluids
• Laboratory processing procedures
• Subject/patient care