NOTE: Selected candidate must be up to date on all immunizations and will be required to complete a pre-employment health screening. They must also have reliable transportation and will need to complete a motor vehicle record check as this position requires driving between the IUSM Indianapolis campus and IU Hospitals in Muncie, IN, and Bloomington, IN. That will likely occur multiple times per month; reimbursement per the travel management policy. May also be working with or have exposure to COVID-19 patients.
SURGERY-CHAIRMAN'S OFFICE (IN-SURC-IUINA)
Provide overall management for the clinical research operations of the Plastic Surgery's Comprehensive Wound Center (CWC) and the Indiana Center for Regenerative Medicine and Engineering (ICRME). Supervise the research staff, including nurses, coordinators, and clinical research specialists and manage resources on the studies. Co-ordinate research performed in multiple IU Health sites which may require some travel to these sites. Be responsible for the NIH funded clinical research unit and its studies. Project management skills are essential for this role. Clinical research managers must plan every phase of Clinical research programs, from initial concept through protocol development and submission for approval by the IU IRB/sIRB/other institutional IRBS, study implementation, execution, and study close-out. Responsible for quality assurance, proper documentation and reporting as well as compliance with policies and procedures. Serve as liaison between clinical staff/physicians, research staff and the sponsors, clinical staff, collaborators and regulatory agencies.
Primary Duties & Responsibilities:
Ensure adherence to grant sponsors, IRB and university accounting and grant administration guidelines.
Provide day to day management and oversight of the clinical research operations for CWC and ICRME, within multiple study sites in the state of Indiana, to ensure successful administration, operations, and financial management. Set priorities as directed by director. Provide systematic direction for all operations of the clinical trials to ensure the organization meets all compliance measures as set forth in the clinical research studies provided by the sponsor. Provide direction for engagement with staff, other departments involved in research initiatives, internal and external customers, other health care systems, and other academic institutions to address project and program development and quality assurance while conducting clinical research which meets all federal, state, and university guidelines. 10 Plan and establish continued usage of any current or new clinical research systems. Oversee staff effort and subject calendars.
Design patient recruitment strategies. Monitor enrollment goals and modify recruitment strategy as necessary. Schedule and coordinate pre-study visits with sponsors.
Assist in all patient facing aspects of clinical research; consenting, scheduling, and study visit completion.
Assist in the preparation of new and continuing applications as they relate to the ICRME & CWC structure. Prepare reports, as needed, regarding accrual, patient demographics, and diagnoses along with other subjects for the Director of the ICRME & CWC.
Prepare and submit IND amendments, annual reports, and other communications to the FDA. Prepare and maintain all regulatory documentation for clinical trials. Coordinate and prepare documents for the Department of Surgery Data Safety Monitoring board activities for all required protocol reviews.
Responsible for employee recruitment and training efforts for all clinical research positions. Travel to liaise with satellite sites.
Master's degree in science or a health-related field and two years of clinical research experience; OR bachelor's degree in medicine and/or surgery (Foreign Medical Grad) and five years of clinical research experience; OR bachelor's degree in science or a health related field and eight years of clinical research experience.
Clinical research certification (ACRP, CCRP or SOCRA).
Knowledge of principles, methods, and procedures for diagnosis and treatment of patients. Strong professional writing, interpersonal, and communication skills. Strong active listening skills. Strong service orientation and understanding of clinical trial finances and medical billing. Strong critical thinking and time management skills. Ability to problem solve, make decisions, coach and teach others including but not limited to direct reports and research residents. Ability to communicate with industry sponsors, develop educational programs, and present group presentations.
Supervisory experience. RN licensure.
Working Conditions / Demands
Must be able to perform all job duties and requirements with or without a reasonable accommodation.
Salary Plan: PAE
Salary Grade: 4RS
Job Function: Research
Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
Equal Employment Opportunity
Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment without regard to age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non-Discrimination here which includes contact information .
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Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.