Provides specialized regulatory and clinical trials support to the Office of Research Billing. Provides specialized project support to the Manager. Responsible for project management as assigned, including leading, coordinating, and completing activities and projects related to clinical research projects and clinical trials.
DUTIES AND RESPONSIBILITIES
1. Responsible for coordinating all submission activities for Investigational Device Studies including preparing documents for hospital and CMS review of IDE protocols, managing files, maintaining database, assisting with device set-up and inventory tracking.
2. Assure accurate, complete, and current records are maintained in accordance with the clinical study protocol and investigation plan.
3. Conduct clinical research billing audits to ensure that devices in clinical trials are being billed appropriately.
4. Assists with budget process for clinical trials, post-award invoicing, and account reconciliation.
5. Assist in educational programs related to regulatory issues, including developing and conducting training.
6. Responsible for the management and completion of clinical research/special projects as assigned.
7. Responsible for knowledge transfer to other staff and may review work of other staff.
8. Responsible for staying abreast of FDA Device Regulations and CMS billing guidelines.
9. Demonstrates the components of the ICARE values statement.
10. Demonstrates ServicePride Standards. Fosters a 'customer focused' environment.
11. Performs other duties as assigned.
1. Bachelor's degree in science or health-related field, or the equivalent combination of education, training and experience from which comparable skills can be acquired.
1. 5+ years experience in healthcare/clinical research operations
2. Experience developing and coordinating IDE application submissions required.
3. Implant device clinical monitoring experience desired.
CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED
1. Certified Clinical Research Coordinator/Professional (ACRP/SoCRA) preferred.
SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
1. Strong analytical and interpersonal skills.
2. Ability to work under pressure and balance many competing priorities.
3. Proficient in spreadsheet, word-processing, and presentation software.
4. Demonstrates effective verbal and written communication skills.
5. Maintains a positive and supportive attitude and demeanor.
6. Professional handling of exposure to confidential/sensitive information.
7. Knowledge of FDA Device Regulations and CMS billing guidelines.
See attached physical activities checklist.
1. The working environment is varied to include general office, with normal amount of lifting, carrying and walking.
2. Demonstrates the ability to use computer technology to review and analyze data, plan and communicate.
Houston Methodist - 2 years ago