Clinical Research Assistant

Responsibilities:
The CR Assistant, with appropriate supervision, is involved in all activities of the clinical trial, providing in house support to the CTB department staff. Primary responsibilities will be:
Maintenance of clinical trial site contracts and amendments, confidentiality and investigator and consulting agreements, and consultant contracts as well as managing the payment of clinical trial sites and suppliers. Ordering and shipment of clinical trial supplies, including investigational trial materials, general reagents / laboratory / office supplies, and the communication with clinical sites as needed to ensure no delays in the study due to shipping logistics. This may include shipment ex-US and customs clearance. Organization and execution of investigator meetings, project teleconference calls, and similar related project communication activities. Support the administration of the Bayer R&D publication review process and the preparation / proofing of Bayer R&D posters at scientific conferences. Support the planning / implementation of in house R&D seminars that are sponsored by CTB. Data entry into clinical trial databases, or data checking of databases for audit purposes. As needed, assist Data Managers with data query communication with the trial sites. Upload of electronic clinical trial data from clinical trial sites as required by clinical trial or data managers and initial review for protocol compliance. Preparation of central study files and filing of critical regulatory documents Preparation and shipment of clinical trial site documentation, critical regulatory documents and general correspondence with trial sites. Assist with project budgets using administrative software tools.

his position provides valuable in house support to the more experienced staff and to clinical research associates when they are monitoring studies at clinical trial sites. The CR Assistant will be required to respond with shifting timelines and multiple projects and to refocus priorities as requested by the Clinical Trials Manager, Clinical Research Associate or Data Manager. The CR Assistant must be able to support clinical trial studies despite the uncertainties of clinical trial plans, negotiations and schedules. Frequently this may require supporting several studies running concurrently. The CR Assistant will help troubleshoot problems for a CRA who is traveling to clinical trial sites and has limited communication with Bayer sites and systems. This helps keep study timelines on track.

Skills:
Ability to handle changing work load, and work effectively in teams. Ability to manage multiple tasks. Excellent written and oral communication skills. Excellent organizational skills. Familiarity with various computer programs, such as spread sheets, word processing, graphics/statistics, presentation packages and electronic communications. Self starter, energetic and willing to learn.

Education & Typical Experience:
Typical education would be a Bachelor's Degree in Science or healthcare related field preferred with 0 - 1 yr. experience.

Additional Information: