Coordinate and participate in clinical research studies conducted by principal investigator(s). Coordinate and participate in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas and phases, in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes.
- Participate in clinical research studies conducted by principal investigator(s) including, but not limited to, grant funded research and/or industry sponsored clinical research conducted on site or its affiliated sites; perform a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data.
- Follow established guidelines in the collection of clinical data and/or administration of clinical studies.
- Confer with study participants to explain purpose of study and obtain informed consent; explain diagnostic procedures and/or treatment plans to alleviate patient and/or family concerns; schedule patient for study procedures; initiate/coordinate drug orders, laboratory procedures and treatments for patients based on standing protocol orders. Collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation; obtain blood samples, cultures, tissues and other specimens for laboratory analysis.
- Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and monitor patients' progress to include documentation and reporting of adverse events; recommend corrective actions as appropriate.
- Evaluate and interpret collected clinical data in conjunction with principal investigator(s) as appropriate; prepare oral presentation or written reports and analyses setting forth progress, trends and appropriate recommendations or conclusions.
- Confer with principal investigator(s) in developing plans for research projects and to discuss the interpretation of results; collaborate on the preparation of manuscripts for publication. Coordinate the development of forms, questionnaires and the application of research techniques; write procedures manuals for data collection and coding.
- Review journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.
- Perform other related duties incidental to the work described herein.
Required Qualifications at this Level
Work requires graduation from an accredited degree program in a clinical field such as a Registered Nurse, Physician's Assistant or Pharmacist plus one year of health care experience, or one of the following equivalents:
1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of three years clinical and/or research experience; or 2. Completion of a bachelor's degree in a field related to health science and a minimum of two years of clinical and/or research experience.
None required beyond that described above.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE