Clinical Trials Group Leader (FT), Lab-Anatomic Pathology Clinical Trials
Position Summary:
Conducts clinical research studies while overseeing the operations of the Cell Labeling Laboratory.
Responsibilities:
- Plans, coordinates, and conducts clinical research studies:
- Develops submissions to the Committee for the Protection of Human Subjects and the Radiation Safety Committee of Mary Hitchcock Memorial Hospital.
- Develops projected budgets for studies
. - Develops a contract for submission to sponsors.
- Develops study timelines which both meet sponsors needs and recognize laboratory capabilities.
- Coordinates acquisition and qualification of necessary supplies and equipment.
- Coordinates assistance from other sections of the Laboratory or Medical Center.
- Oversees and reviews acquisition, compilation and analysis of study data.
- Ensures the maintenance records.
- Maintains correspondence with overseeing committees.
- Keeps the Medical Director apprised of important events, adverse outcomes and milestones.
- Oversees both the general structure and function of the Cell Labeling Laboratory:
- Ensures that Standard Operating Procedures (SOP’s) are both current and correct by reviewing all SOP’s annually. Writes or oversees the writing of new SOP’s.
- Reviews all quality control checks and bring significant deviations to the prompt attention of the Medical Director.
- Reviews the operational needs of the Laboratory making acquisitions or suggesting the acquisition of new equipment.
- Maintains financial records and approves all expenditures. Projects the status of the Laboratory’s financial reserves on an annual basis.
- Maintains the Laboratory’s web site.
- Supervises the staff of the Cell Labeling Laboratory:
- Maintains up to date job descriptions.
- Manages recruitment and hiring functions.
- Ensures the adequate training of new staff.
- Reviews staff proficiency, providing on-going feedback and annual evaluations.
- Assumes responsibility for the lay-out of schedules of staff functions to accomplish projects.
- Provides oversight, guidance and troubleshooting assistance to staff.
- Performs other duties as required or assigned.
Minimum Qualifications:
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3 years of combined laboratory and supervisory experience required.
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Advanced degree in a business field preferred.
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Prior experience in a research environment highly preferred.
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Excellent written and oral communication skills required.
Required Licensure/Certification Skills:
MT (ASCP)