Clinical Research Specialist 1 (Req 1-2 Yrs Patient-Facing Exp)
About The Position
This role involves identifying, developing, recommending, and implementing moderately complex process development and process improvement solutions to optimize global trial workflow timelines. The specialist will develop and execute device processes associated with clinical trials, ensuring compliance with regulations and managing the device lifecycle. This includes partnering with internal stakeholders such as clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups to develop and lead the execution of the device process, and ensuring continuous process improvement of efficiency and accuracy. The role also requires verifying inventory, processing device shipments to clinical sites, confirming receipt of product with clinical sites, monitoring device inventory, developing timeline assessments, ensuring appropriate archiving of documentation, and tracking/managing clinical study invoice processing. Additionally, the specialist will support clinical research laboratory operations as needed and perform other incidental duties.
Requirements
- 1–2 years of patient-facing experience in a clinical research, healthcare, or related medical setting.
Nice To Haves
- Associate's/Bachelor’s degree in a related field
Responsibilities
- Identify, develop, recommend, and implement process development and process improvement solutions to optimize global trial workflow timelines.
- Develop and execute device processes associated with clinical trials.
- Ensure compliance with regulations and manage the lifecycle of devices.
- Partner with internal key stakeholders to develop and lead the execution of the device process.
- Ensure continuous process improvement of efficiency and accuracy of processes and procedures.
- Verify inventory and process device shipment to clinical sites.
- Confirm receipt of product with the clinical site and obtain copies of signed and dated packing slips.
- Monitor device inventory by coordinating with Supply Chain and Clinical Specialists.
- Develop timeline assessments in collaboration with clinical stakeholders.
- Ensure documentation are archived appropriately within record retention facility.
- Track, manage, and coordinate clinical study invoice processing.
- Generate reports on outstanding invoice payments for clinical study team review.
- Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive.
- Support clinical research laboratory operations as needed.
- Perform other incidental duties as assigned.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
