The ideal candidate would be someone who has a good understanding of the conduct of clinical research and human subjects regulations, this could apply a clinical research assistant or coordinator that is looking to take their experiences and apply them to the oversight and compliance of clinical research activities or other professionals working in human subjects research. Candidates must be detail oriented and have good communication skills, both written and verbal.
Assist with scheduling, preparing for and performing audits of clinical research protocols and prepare draft findings. Provide real-time education to Principal Investigators and members of the research team while conducting audits. Tracks completion of corrective action requirements for investigators who had a for-cause or not-for-cause audit performed.
Provide audit report, findings and proposed corrective action plan to the Human Research Protection Program (HRPP) Director for reporting to the Committee on Clinical Investigations (IRB) on a timely basis.
Assist in gathering data and educational evaluations. Present these to other members of the Human Subjects Protection Office (HSPO) on a regular basis to help guide educational programming.
Attend Committee on Clinical Investigations meetings as a consultant to gather information for the HSPO re: potential human subjects concerns and education needs as needed.
Required Qualifications:Bachelor's degree required.
3-5 years related work experience required.
Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.
Competencies:Decision Making: Ability to make decisions that are guided by general instructions and practices requiring some interpretation. May make recommendations for solving problems of moderate complexity and importance.
Problem Solving: Ability to address problems that are varied, requiring analysis or interpretation of the situation using direct observation, knowledge and skills based on general precedents.
Independence of Action: Ability to follow precedents and procedures. May set priorities and organize work within general guidelines. Seeks assistance when confronted with difficult and/or unpredictable situations. Work progress is monitored by supervisor/manager.
Written Communications: Ability to summarize and communicate in English moderately complex information in varied written formats to internal and external customers.
Oral Communications: Ability to comprehend and communicate complex verbal information in English to medical center staff, patients, families and external customers.
Knowledge: Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.
Team Work: Ability to work collaboratively in small teams to improve the operations of immediate work group by offering ideas, identifying issues, and respecting team members.
Customer Service: Ability to provide a high level of customer service and staff training to meet customer service standards and expectations for the assigned unit(s). Resolves service issues in the assigned unit(s) in a timely and respectful manner.
Physical Nature of the Job:
Sedentary work: Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, with walking and standing required only occasionally