Clinical Trials Administrator (CTA)

Medical Devices - Class I, II, III

Office based in Minneapolis, MN

Clinical Trial Administrator (CTA) performs study-related tasks as required by the
Department, including (but not limited to): communicate with Project Team and members
of the project team regarding study updates, maintain documentation as required by

protocols, standard operating procedures (SOPs) and regulatory authority standards, to ensure timely production of high quality study documentation, provide system's support, track information related to the status of study
activities, and assist with general administrative functions as required.

Essential Job Duties:
1) Documenting and tracking study activities using relevant forms and tools, as well as relevant project management system with guidance/support from project or clinical team lead.
2) Assist in the preparation of study site specific materials in accordance with relevant SOPs
3) Assist with minute taking and documentation for sponsor/external or internal teleconferences as requested
4) Assist in setting up and maintaining tracking systems (e.g., study supplies and investigator payments)
5) Provide clerical support to project team (e.g., proof-reading and editing correspondence, drafting large and small documents, mailings, shipment of study files, fax and photocopy documents, assemble study documents, and arrange meetings, etc.)
6) Maintain trial master file documentation and tracking/archiving per SOPs
7) Perform other administrative duties as assigned by management
8) Might occasionally be requested to work in a client facing environment

Education/Qualifications

Minimum Required:
- Diploma-secondary education or equivalent

Preferred:
- College degree (4 year) in biological sciences or equivalent

Experience

Minimum Required:
- Minimum one (1) year administrative experience or equivalent training in clinical research or a contract research organization
- Good oral and written communication skills

Preferred:
- Aptitude for handling and proof-reading, some Microsoft Office Excel spreadsheet software competency
- Good organizational and time management skills
- Computer literacy (Microsoft Office)
- Good typing skills
- Good spelling and proof-reading skills
- Aptitude for handling and reviewing regulatory required clinical trial documentation
- Ability to operate standard office equipment (e.g., printer, fax, copier)
- Works efficiently and effectively in a matrix environment