Job Title: Research Assistant
Reports To: Clinical Research Group Leader
Duties and Responsibilities (including, but not limited to, the following):
- Conduct study procedures in coordination with Research Coordinator, in compliance with company SOPs, and as defined by the Delegation of Authority for study.
- Collection, processing, storage, and shipment of laboratory specimens (phlebotomy, centrifugation, aliquoting, etc.)
- Generation of laboratory logs.
- Inspection and coordination of clinical equipment calibration with qualified vendor.
- Management of clinical supply inventory for assigned studies (i.e. sponsor provided laboratory kits and bulk supplies)
- Preparation for study procedures, including gathering source and essential documents, acquiring dry ice, maintain patient schedule, and other procedures/requirements to ensure compliance with study protocol.
- Document study/clinical data to CRF, EDC, CTMS, and any other required system as needed. Ensure entries are accurate, verifiable, and timely.
Assist Regulatory Manager with maintaining study documents and other administrative duties as needed.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Minimum one-year experience in clinical or research setting performing phlebotomy and clinical assessments. Clinical laboratory experience preferred.
- Associates degree or higher.
- Proficient in the use of medical systems equipment and ability to train for use of specified medical assessment tools.
- Experience with Electronic Data Capture (EDC) and Clinical Trial Management Systems preferred.
- Computer/IT literacy [MS PowerPoint, Excel, Word]
- Interpersonal skills, with strong written and oral communication skills
- Accuracy and attention to detail
- Excellent organizational skills
- Strong work ethic
Travel: Regular travel between multiple sites at various times.
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 stand; walk; use hands; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. The employee is occasionally required to sit. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.