Current Openings
Biodel believes that a creative and talented team is our greatest asset. We nurture this asset with a stimulating and challenging environment that encourages personal achievement and professional success.
Biodel offers competitive salaries, benefits and a stock option plan to ensure that our entire team will benefit from the company’s success.
For information about Biodel career opportunities, please direct inquiries to: careers@biodel.com.
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Clinical Research Associate
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| Type: |
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Full time |
| Company: |
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Biodel Inc. |
| Location: |
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Danbury, Connecticut 06810 |
| Start Date: |
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ASAP |
| Benefits: |
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Healthcare, 401K, FSA 125, stock option plan |
Description:
- Clinical monitor for Phase III studies involving multiple sites and support new additional studies.
- Responsible for participating in the operational activities involved in the planning, initiation and conduct of clinical trials.
- Activities include but are not restricted to supporting: Investigator recruitment, site screening and selection; maintenance and communication of investigators lists; protocol and CRF review; informed consent review; monitoring guidelines review; development of local investigator site file; regulatory document review and tracking; interacting and corresponding with investigators, study coordinators, regulatory affairs and central IRBs, and central lab, managing and submitting documents to clinical trial master file; ordering, managing and tracking of clinical supplies. Monitor and track SAEs and safety data reporting procedures to ensure compliance.
- Coordinate trial-related activities in order to adhere to planned timelines.
- Approximately 50% travel
Minimum Requirements:
- 1-2 years experience in clinical research, in the pharmaceutical industry, preferably in the area of diabetes.
Preferred Experience:
- Phase III trial experience
- Research involving European sites
- Trials with 30 or more investigative sites
- Proven ability to multi-task and set priorities in order to meet aggressive timeliness
- Excellent communication skills
- Ability to work a flexible work scheduled based on the operational needs of the trial.
Excellent Opportunity.
Email resume and salary requirements to careers@biodelinc.com .
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