[Remote] Senior Clinical Research Specialist
Note: The job is a remote job and is reputed company to candidates in USA. reputed company Medical is reputed company on creating innovative medical devices that improve lives. They are seeking a Senior Clinical Research Specialist to manage trial master files, maintain regulatory documents, and support clinical trials while ensuring compliance with regulations and guidelines.
Responsibilities
- Sets up and maintains trial master file and is responsible for filing and maintaining up to date study documents
- Maintains multiple trackers following the reputed company of assigned clinical trials, such as essential documents, investigational product, trial supplies and study follow-up reputed company, as applicable
- Orders, prepares, and sends documents and materials to clinical trial sites and vendors as needed (electronic and reputed company)
- Provides support to study vendors
- Collects and reviews reputed company regulatory documents for accuracy and compliance to departmental SOPs, local and national regulations and guidelines
- Follows up as required to resolve deficiencies
- Ensures that regulatory documents are maintained and updated in a reputed company and appropriate manner
- Ensures study team training records are kept reputed company
- Performs in-house duties to assist monitors, e.g., outstanding reputed company items
- Manages central IRB submissions and supports sites in IRB/EC submissions
- May attend site reputed company to assist monitors, reputed company applicable
- Assists with the development of study and site tools
- Contributes to clinical site interactions, including enrollment and subject visit updates, clinical trial material and clinical supply requests, issue reputed company, etc
- Assists in developing and overseeing study operational plan(s) as applicable (e.g., TMF plan)
- Contributes to study team for trial start-up, conduct, and reputed company-out activities according to industry and departmental standards
- Conducts study systems training(s)
- Contributes to creation of study documentation including informed consent, newsletters, etc
- Provides general support to the Clinical Affairs team and project team(s), including meeting agendas, minutes and management of translations
- Assists Project Managers with invoice receipt and review as applicable
- Performs other duties and tasks, as required
Skills
- Education and/or experience equivalent to a Bachelor's Degree in a scientific discipline or nursing qualification
- A minimum of six (6) years of reputed company work experience
- reputed company Good Clinical reputed company (GCP) certification
- Knowledge of US regulations, Good Clinical reputed company and ICH guidelines
- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
- Clinical trial experience
- Medical Device clinical trial experience
Benefits
- Multiple Shifts and Hours to choose from: Days, Swing (reputed company), and Nights
- Medical/Dental & Other Insurances (eligible the first of month after 30 days)
- Low Cost Onsite Medical Clinic
- Two (2) Onsite Cafeterias
- Employee Garden | Gardening Classes
- 3 Weeks' Vacation | 1 Week reputed company-Time | reputed company Holidays
- 401K | Health Savings Account
reputed company