Clinical Trial Assistant / eTMF (Electronic Trial Master File) Coordinator
Clinical Trial Assistant / eTMF (Electronic Trial Master File) Coordinator
About Krystal Bio:
At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, and delivery of transformative medicines for people with serious and life-threatening genetic diseases. Founded in 2016, the Company is the leader in redosable gene therapy with prominent clinical and pre-clinical stage programs for dystrophic epidermolysis bullosa, TGM1-deficient ARCI, Netherton Syndrome, Cystic Fibrosis, alpha-1 antitrypsin deficiency, and is advancing research to apply our technology to these and other diseases. The Company’s innovation is fueled by visionary leadership within an entrepreneurial organizational structure with a robust pipeline of investigational medicine.
Our US headquarters is in Pittsburgh, PA with other offices located in Boston, MA and in Zug, Switzerland. For more information about the Company’s platform, commitment to patients and pipeline, please visit http://www.krystalbio.com and engage with us on Twitter and LinkedIn.
We have an exciting journey ahead and a tremendous opportunity for growth, and now is the time to make a meaningful impact on the lives of our patients!
Job Description Summary:
We are currently seeking a highly organized, detail-oriented Clinical Trial Assistant / eTMF Coordinator to join our dynamic team. This individual will play an essential role in supporting our clinical trial operations and overseeing the electronic trial master file (eTMF) system.
Primary Responsibilities:
- Coordinate the preparation, assembly, and distribution of clinical trial documentation and reports.
- Manage and maintain the eTMF system, ensuring timely submission of documents, completeness, and accuracy. Regularly conduct quality checks on the eTMF system.
- Assist clinical trial team with the organization, planning, and execution of clinical trials in accordance with standard operating procedures, good clinical practice, and applicable regulatory requirements.
- Liaise with project managers, clinical operations staff, and other relevant team members to facilitate document collection and retention.
- Review study-related or essential documents for completeness and compliance with protocol and relevant regulations.
- Organize investigator meetings, prepare meeting materials, and track action items.
- Monitor the progress of clinical trials and report updates to the project manager or clinical team lead.
- Assist with the resolution of any issues or queries that arise during the clinical trial.
- Participate in regulatory and study audits, supporting the team in the preparation and follow-up activities.
Required Skills and Qualifications:
- Bachelor's degree in life sciences, healthcare, or a related field.
- Previous experience in a similar role, preferably within a pharmaceutical or biotech environment.
- Knowledge of clinical research processes, regulatory requirements, and good clinical practice (GCP).
- Familiarity with eTMF systems and other clinical trial management systems.
- Excellent organizational skills and attention to detail.
- Strong communication skills, both written and verbal.
- Ability to work in a fast-paced environment and manage multiple priorities.
- Proficiency in MS Office (Word, Excel, PowerPoint).
Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.