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The Clinical Research Coordinator I oversee the conduct of clinical research investigations involving patients and community participants. Employee possesses an in-depth knowledge of federal regulations and guidance for the conduct of clinical trials and human subject protection, assuring compliance with protocol and regulatory requirements, and by collecting, recording, and maintaining data and source documentation.
1. Assist in research planning, design and implementation including the development of standard operating procedures (SOPs), research forms and source documentation tools. 2. Coordinate and participate in recruitment activities, subject enrollment, and follow-up procedures for multiple research protocols. 3. Using proper laboratory and phlebotomy technique, ensure appropriate specimen collection, processing, and shipping as required per protocol. 4. Maintain compliance with GCP guidelines for the conduct of research including study documentation and subject confidentiality/privacy. 5. Prepare for, schedule, and participate in meetings with research sponsors, contract research organizations (CROs), government and other regulatory entities. 6. Obtain and manage regulatory and Institutional Review Board (IRB) approvals and communications. 7. Demonstrate an understanding of research regulatory compliance and participate in educational opportunities to increase research involvement and awareness of regulations, policies, and study activities. 8. Collaborate with Research Center staff and other departments in order to accomplish research goals. 9. Promote a team atmosphere by treating individuals with respect and honesty and by using direct communication and active listening skills. A. Be open to change and actively support change. B. Be open to others' ideas and points of view. C. Adhere to following policies and procedures for Rogers. 10. Promote department goals as well as the mission of Rogers. A. Demonstrate measurable goal achievement. B. Adhere to department policies and procedures. C. Resolve individual issues with peers in a positive, solutions focused manner. D. Include requirements and guidelines from external agencies (i.e., Joint Commission, State of Wisconsin). 11. Participate in Roger's committees, performance improvement team meetings, and team projects, as directed. A. Demonstrate punctuality and preparedness. B. Demonstrate effective communication skills. C. Demonstrate good organizational skills. D. Contribute in a positive, solution-focused manner. 12. Conduct self in a professional manner. A. Demonstrate organizational skills that promote timely response to all inquiries and to task completion. B. Communicate with all individuals in a positive and professional manner. C. Attempt to resolve individual issues with peers in a positive, calm manner, with a focus on solution. D. Communicate concerns and provide solutions for same. E. Project a professional image by wearing appropriate, professional attire. Additional Job Description: Physical/Mental Demands:
- 1. Strong interpersonal skills needed, due to interaction with professional staff and research participants.
2. Must be able to work independently and complete assignments within specified timeframes. 3. Must be highly proficient in verbal and written communication skills. 4. Position requires walking, sitting, and standing. Lifting is moderate; must be capable of lifting a minimum of twenty (20) pounds. Reaching, handling, grasping, and manual dexterity are necessary to operate various office equipment. Stooping, bending, kneeling and flexible movements required to work with orientation equipment. 5. Verbal and hearing ability required to interact with patients and employees. Numerical ability required to maintain records and operate computer. 6. Be able to plan, control and direct all aspects of employee relations. Tact required to deal effectively with staff. Logical thinking and discretion required to make decisions in initiating and implementing policies and procedures and standards.
Education/Training Requirements:
- 1. Associates degree in behavioral science, nursing or a related field required. Bachelor's Degree preferred. [LPN or CNA and minimum (3) three years of research experience may be considered in lieu of advanced degree requirements.]
- 2. Minimum of three (3) years of work experience in a clinical or research setting.
3. Competence in research methodologies and knowledge of clinical protocols; Analytical skills and the ability to resolve technical or research problems and issues; experience working with IRBs. 4. Preferred phlebotomy certificate and ability to perform EKGs and obtain vital signs. 5. Proficient with various computer software programs, hardware devices, and ability to learn laboratory equipment. 6. Completion of applicable research training certification through CITI or comparable program. May be completed within first 30 days of employment. 7. American Heart Association Healthcare Provider CPR certification or American Red Cross Professional Rescue is preferred and may be required within thirty (30) days of hire. 8. Formal training in management of the aggressive patient is required within sixty (60) days of date of hire. Annual re-certification is required.
With a career at Rogers, you can look forward to a Total Rewards package of benefits, including:
- Health, dental, and vision insurance coverage for you and your family
- 401(k) retirement plan
- Employee share program
- Life/disability insurance
- Flex spending accounts
- Tuition reimbursement
- Health and wellness program
- Employee assistance program (EAP)
Through UnitedHealthcare, UMR and HealthSCOPE Benefits creates and publishes the Machine-Readable Files on behalf of Rogers Behavioral Health. To link to the Machine-Readable Files, please visit Transparency in Coverage (uhc.com)
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