| Job Ref: |
400370926
| Employer: | Duke Nursing
| Industry: |
Nursing
Healthcare / Medical
| Job Type: |
Full Time
| Career Level: | - | Degree Level: |
High School
Trade School / Certificate / License
| Country: |
United States
| State/Province: |
North Carolina
| City: |
Durham
| Address: | | Salary: |
Inquire
| Post Date: | 02/19/2012 06:12 AM |
Occupational Summary:
Plan, oversee and develop processes for successful implementation of multi-center research projects involving phase I, II, III, FIM, feasibility and pivotal clinical research projects for the eECG and Imaging Core Laboratories, cardiac safety for profit subsidiary and DIVAs. Duties include a range of organizational and administrative functions necessary to fully document research functions and resulting data.
Work Performed:
Manage the work ofthe assigned project staff and provide recommendations to senior project leader and general manager regarding personnel actions, scheduling, work assignments, disciplinary actions, promotions and transfers. Perform performance appraisals on assigned staff following PPS guidelines.
Communicate with sponsors, site principal investigators on core laboratory protocol and provide feedback to project staff to ensure compliance with SOPs, Federal Drug Administration and protocol guidelines. Identify potential problems or inconsistencies and take
action as needed.
Monitor SOPs to facilitate administration of clinical research projects and collection of data. Identify deviations to standard procedures and work instructions as required.
Oversee the development with principal investigator, statistician and data management the CRF and site materials. Coordinate site training and site certification at US and OUS investigator meetings. Monitor enrollment updates and other sponsor, site, and/or
coordinating center communications. Provide weekly project updates to senior project leader, general manager, and principal investigator.
Participate with senior project leader in the development of scope of work and budget in order to allocate expenses. Assist with project budget negotiations. Monitor project expenditure and work performed. Review and provide to senior project leader detail to support monthly invoicing and other reports as requested.
Develop with principal investigator, operational plans, timelines and project processes. Recommend modifications as necessary. Ensure timelines for deliverables are met.
Identify operational problems, direct remedial action and request support from senior project leader, general manager and principal investigators as appropriate.
**Cardiovascular, ECG and imaging experience is preferred.
Perform other related work as needed.
Education
Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physicians Assistant (PA) or Pharmacist plus two years of healthcare experience, or one of the following equivalents: 1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare experience; or 2. Completion of a masters degree in Public Health, Health Administration or a related area with one year directly related clinical trials research experience; or 3. Completion of a bachelors degree plus a minimum of three years directly related experience in clinical trials research; or 4. Completion of a bachelors degree plus a minimum of four years closely related research experience. **State of North Carolina license may be required.**
Experience
None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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