- Work with PIs, under moderate guidance, in coordinating activities related to recruitment for clinical trials including recruitment of study participants, conduct interviews, and evaluate potential participants; obtain informed consent, and collect and maintain subject data; perform research subjects’ assessment and Neurologic Rating Scales (NIHSS, mRS, MDS-UPDRS, UDysRS, MoCA, C-SSRS, etc).
- Provide input into the design, development, execution and initial interpretation of clinical trial protocols, treatment plans, compliance forms, and tracking documents.
- Conduct research work and perform professional literature reviews to assist the Principal Investigator in designing appropriate research methodologies, techniques, and procedures.
- Serve as a patient resource for concerns and information.
- Prepare, coordinate and/or maintain regulatory documentation including IRB submission and approval of new or revised protocols, safety reports and progress reports.
- Collect and submit the required documentation to the Institutional Review Board, the University, and corporate or government sponsors. Enter and manage study data in compliance with GCP standards
- Participate in data management design and maintenance.
- Develop administrative and financial recommendations for department management and PIs for research portfolio review. Oversee quarterly review of all Principal Investigator accounts, performing a strategic analysis of PI research portfolios.
- Collaborate with the Principal Investigator in the preparation of Human Subjects documentation for NIH and other federally funded grant applications.
- Create and prepare education materials and training to patients, family members, and clinical staff to assure patient safety and adherence to protocols.
- Administer and assist in the proper collection, processing, storage, and transport of biological specimens and ensure their handling.
- Order and maintain supplies required for study kits, track spending in this area, and make day-to-day decisions in support of the study.
- May mentor and train new staff in preparation and conduct of clinical trials.
Knowledge, Skills, and Abilities:
- Knowledge of the principles, practices, and techniques of research clinical skills.
- Motivated to provide high quality, compliant research.
- Skill in maintaining detailed records.
- Desire to build new program and develop new policies.
- Ability to work both independently and with a team, resolving issues with a positive outcome.
- High level of integrity, ethics and professionalism.
- Strong communication and computer skills.
- Strong organization skills and significant attention to detail for data entry.
