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About PMR Bio-Brain:
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PMR Bio-Brain is an executive search firm dedicated to the pharmaceutical and biotech industries. Our focus includes hospital executives, hospital pharmacy, and allied health professionals.
Click here to go to the PMR Bio-Brain website.
For details about PMR Bio-Brain, click here.
About the Opportunity/Requirements:
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1)Oversees the operation of the Clinical Research Unit, facilitating the creation and maintenance of a safe, comfortable, and therapeutic environment for subjects, visitors, and staff.
2)Management and supervision of all clinic staff including nurses, paramedics, clinic attendants phlebotomists and laboratory technicians during all relevant clinical and non-clinical activities to ensure compliance to GDP, GCP, and applicable regulatory guidelines.
3)Participates in study conduct and study related tasks as required
4)Responsible for the scheduling of staff to accommodate study needs and timelines to ensure effective utilization of study resources.
5)Provide training orientation and mentoring as needed to ensure that employees improve their skills and work according to Study Protocol, Standard Operating Procedures and Good Clinical Practices in the conduct of clinical.
6)Responsible for long-term planning, budget management, goals, outcomes, decision-making and other higher-level management functions as well as insuring a productive and efficient clinic.
7)Responsible for project-specific feasibility assessment and procedure development based on project requirements.
8)Prepares payroll information and forwards to Human Resources as necessary.
9)Maintains employee attendance and vacation/sick time.
10)Manages the purchasing of supplies and evaluates the need for additional equipment and supplies.
11)Reviews all invoices and billing statements, checking for accuracy, before forwarding them to Accounts Payable.
12)Leads regular clinic staff meetings to inform the staff of new information and directives that will be implemented.
13)Participates actively on the senior management team for the Phase I Clinical Research Unit
14)Assumes responsibility for personal and professional growth.
15)Strives to maintain a positive work environment for staff.
16)Participates in creation and maintenance of clinical Standard Operating Procedures.
17)Performs any non-study related tasks as required or any additional duties as professional qualifications and training permits.
Requirements
1)A Registered Nurse with clinical research experience, preferably in a Phase I Clinical Research Unit.
2)Current RN License.
3)Certification in Clinical Research is preferred.
4)Relevant supervisory experience.
5)Current ACLS certification.
6)Minimum 3-4 years experience as a Clinical Research Nurse or Advanced Care Paramedic in a research setting.
7)Certification and or training in Good Clinical Practices.
8)Expert ability to apply ICH/GCP and other guidelines, and FDA and other relevant regulations.
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