Summary of Essential Duties and Responsibilities
The primary function in this position will be to provide departmental administrative support in the area of Clinical Affairs, including:
Perform quality checks, uploads and tracking of required regulatory documents to populate the electronic Trial Master File (TMF) for designated studies. Generate reports of missing documents and upcoming expiration dates. Communicate with sites and/or study team to obtain required documents. Ensure the TMF is audit-ready in support of regulatory filings.
Obtain safety-related source documents and images from clinical sites in preparation for Clinical Event Committee and Data Safety Monitoring Board meeting packages. Work with translation vendors as needed.
Track device inventory and prepare shipments to sites, ensuring device integrity is maintained (i.e., temperature control and expiration dates). Process returned/expired devices.
Assist with the distribution and tracking of clinical study supplies to Contract Research Organizations (CROs) and clinical centers (e.g. study binders, case report form worksheets, study devices and misc. materials)
Interface with CROs to obtain study-related documentation and follow up on action items
Assist with site invoicing and payment tracking
Assist with organization and filing of study related materials
Assist in the organization and execution of Investigator meetings
Provide general administrative support as needed
Education and/or Experience
Undergraduate degree
2-3 years of relevant clinical trial experience
Required Knowledge/Skills
Minimum of 1-2 years of clinical study electronic Trial Master File experience
Proficient with basic computer programs such as Microsoft Word, Excel PowerPoint and Adobe Acrobat
Detail oriented in document review and error checking
Effective communication skills
Desired Knowledge/Skills
Minimum of 1-2 years of Sponsor or CRO experience
Working knowledge of CDISC TMF Reference Model
Physical Demands/Working Environment
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 frequently required to sit or stand for prolonged periods of time, frequently in front of a computer.
...Job Description Job Description Description: Are you a newly licensed Registered Dental Assistant ready to launch your career? Mansfield Dental is looking for an enthusiastic, eager-to-learn RDA to join our team. We love new grads! We will invest in your development...
...experience within specialty. Required - Required AHA BLS, ACLS, & NIH Certification. Northside Holiday Expectations: MUST work 2 major Holidays of the 3: Thanksgiving Day Christmas Day New Year's Day AND 1 Minor Holiday: The Friday after Thanksgiving Christmas Eve New Year...
...Job Description Job Description Join Golden Years In-Home Senior Care! Were looking for caring, HCA-certified caregivers with a passion for serving others. If you love creating joyful moments and providing excellent care, we want you on our team! Your Role:...
...Job Description Blood Bank Manager opening in Lexington, Kentucky \n This is a permanent leadership position with a large healthcare organization looking for someone with strong Blood Bank operations, quality, and regulatory experience. \n Position Highlights...
...In This Role, Your Responsibilities Will Be: Customer Management and Service Ownership Partner with Sales and customers to develop service... ..., define expectations, and establish SLAs for service delivery. Serve as the single point of contact for service agreement...