Job Title: Internal Clinical Research Associate
Department: Clinical Operations
Reports To: VP of Clinical and Regulatory Operations
The Internal CRA monitors and coordinates the research and administrative activities of clinical trials for Gradalis. The CRA works for the VP of Clinical and Regulatory Operations to provide support in compliance with the FDA Code of Federal Regulations (CFR), the ICH Good Clinical Practice (GCP) Guidelines, OHRP/DHHS guidelines and Gradalis Standard Operating Procedures.
Duties & Responsibilities (Other duties may be assigned)
- Initiates essential document collection process, as specified for new trials. Maintains and updates trial master file. Works with site and Site Research to track obtain updated documents and resolve pending queries. Reviews documents for completion and generates queries as necessary. Prepares applicable documents for FDA submission.
- Works with Site Research to prepare clinical trial monitors for site visits.
- Processes protocols and amendments including informed consent changes and/or revisions for Food and Drug Administration (FDA) and other regulatory body review and site distribution.
- Assists in preparing reports, packages and scheduling meetings for FDA meetings and submissions. Maintains Gradalis electronic Common Technical Document (eCTD)
- Assist in implementation of new databases and software systems to track clinical trial data, samples, and manufacturing needs.
- Works with Data Management and Site Research to coordinate data locks with site for data review, interim review and final database lock.
- Participate in regular meetings with the appropriate departments to develop and / or improve processes
- Assist in the interface with the FDA and other regulatory agencies, when necessary
- Works with manufacturing operations to ensure sites have adequate supplies to conduct clinical trials.
- Communicates with sites and tracks incoming clinical samples. Provides feedback to sites regarding manufacturing and quality control release status. Coordinates with third party vendor of analysis of samples, as necessary.
- Other administrative duties as assigned
- Solid telephone skills. Concise and accurate verbal and written communications skills. Ability to read and interpret documents such as safety rules, and procedure manuals. Ability to write routine reports and correspondence. Ability to interact effectively with all levels of employees in organization.
- Clinical research or regulatory certification preferred
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to sit. The employee frequently is required to use hands to finger, handle, or feel and talk or hear. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus.
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
- The noise level in the work environment is quiet to moderate.
No required travel outside the DFW metroplex. Any local travel will be reimbursed in accordance with company policy.
- 3 or more years of relevant experience
- Bachelor’s degree (life or health science) and related work experience in quality and / or regulatory systems.
- Significant work experience with MS Office
- Experienced, confident leader with results orientation
- Must be easily adaptable to changing priorities and deadlines, be well organized, articulate, and possess good writing skills
- Statistical background, a plus