Contract Clinical Research Assistant (3 to 6 months)
About The Position
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. Track and ensure study-related images are obtained from sites and provided to Core Labs for analysis in a timely manner. Assist in providing feedback to sites as needed. Obtain safety-related source documents 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 Assist in processing and tracking of study related costs Provide general administrative support as needed
Requirements
- Undergraduate degree
- 2-3 years of relevant clinical trial experience
- 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
Nice To Haves
- Minimum of 1-2 years of Sponsor or CRO experience
- Working knowledge of CDISC TMF Reference Model
Responsibilities
- 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.
- Track and ensure study-related images are obtained from sites and provided to Core Labs for analysis in a timely manner.
- Assist in providing feedback to sites as needed.
- Obtain safety-related source documents 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
- Assist in processing and tracking of study related costs
- Provide general administrative support as needed
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
