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Job Type:
RegularScheduled Hours:
40Job Summary:
The Clinical Research Documents and Budgets Specialist is responsible to negotiate, execute, and maintain the integrity of basic to complex Industry and grant sponsored research agreements and contracts for clinical trials as well as other agreements relevant to the Clinical Research Institute (CRI); to develop, negotiate, and coordinate budgets for industry sponsored research clinical trials, each in accordance with St. Elizabeth Clinical Research Institutes policies, various human subject research certifications and federal laws and regulations; to identify, resolve or mitigate regulatory compliance, financial, intellectual property and other risks; to advise, support, guide and provide consultation to the Research Team on feasibility and financial management of industry sponsored research clinical trials to develop and support a sustainable clinical research program that leads to improvements in medical care for patients.Demonstrate respect, dignity, kindness and empathy in each encounter with all patients, families, visitors and other employees regardless of cultural background.
Job Description:
Collaboration
- Advanced verbal, written and/or interpersonal communication skills.
- Proactively work with the Research Team to foster good working relationships with staff, management personnel and external industry partners.
Document Administration
- Apply a comprehensive understanding of contract principles, federal regulations, laws and internal policy and operating procedures to develop, issue/review, and negotiate industry sponsored research agreements for clinical trials; identify compliance, intellectual property and business/budget risks, and take appropriate steps to mitigate identified risks through communication with the Research Team, Legal Team, and/or others, to propose acceptable verbiage and terms for contract negotiations with industry sponsors.
- Use independent and, when appropriate, collaborative judgment, to complete contract negotiations.
- Responsible for review and completion of contract Amendments.
Budgets/Financial Management
- Prepare, develop, review and negotiate budgets to cover the costs associated with clinical trials.
- Responsible for effectively negotiating Industry proposed budget(s) to obtain sufficient funding to successfully conduct proposed clinical trials.
- Assist in prioritizing the importance of budgetary items to increase revenue and weigh the risks associated with each.
- Assist with costs analysis to determine anticipated revenue.
- Analyze and document the initial sponsor budget vs. the negotiated final budget.
- Work in tandem with the Research Team to effectively track and analyze budget vs. actual costs.
- Assist in analysis of trial expenditures to ensure they remain within budget parameters, (i.e., travel, training & development, recruitment/orientation, and study workflow).
Process Improvement:
- Organize and participate in activities to improve contract/budget processes.
- Improve organizational performance by recommending areas or approaches for improvements.
- Use creative and effective communication and presentation skills.
- Develop resources for effective contracts and budget negotiations.
- Develop educational materials and contribute to planning and presenting educational programs.
- Participate in establishing job requirements and goals and perform duties at the desired level of competency. Propose potential solutions to identified issues and demonstrate follow through actions.
Coordination
- Support Services: Effectively identify, prioritize, and communicate with the Research Team and Administration.
- Demonstrate clear, diplomatic, and effective oral and written communication skills to the Research Team, administrators, and industry sponsors.
- Exhibit initiative, effort, resourcefulness, and professional demeanor in all areas of responsibility.
- Develop, nurture, and strengthen internal and external relationships.
- Establish and maintain effective working relationships with the Research Team.
- Provide guidance and training on relevant aspects of budget and contracting issues to these constituencies.
- Ensure reasonable follow-up on outstanding issues and escalate relevant issues as appropriate.
Data Analytics
- Work collaboratively with Financial Analyst to review the analysis of clinical trials that will aid in decision making and recommendations.
- Performs other duties as assigned.
Education, Credentials, Licenses:
- Bachelors Degree in Business, Finance or related field
Specialized Knowledge:
- Related experience in clinical research or document management
Kind and Length of Experience:
- 3-5 years of related experience with developing and negotiating clinical trials contracts and budget
FLSA Status:
ExemptRight Career. Right Here. If you're looking for the right careers in healthcare, the right place to be is at St. Elizabeth. Join us, and you'll take pride in the level of care we offer our community.
