One of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at IU School of Medicine has a rich history of training geneticists and genetic counselors and providing genetic consultation and counseling services. The department contributes to the understanding of numerous genetic conditions through the integration of basic research in genetic and genomic mechanisms, translational research in disease models, and clinical trials in rare and common genetic diseases.
The Department of Medical and Molecular Genetics currently manages 20+ clinical trials. Last year, the department growth increased by 155%.
Job Summary
Department-Specific Responsibilities
Develops study-specific process guides, nursing orders, and source documentation; participates in study visits; meets routinely with study team to manage progress of subjects and studies.
Manages clinical trial studies for the Department of Medical and Molecular Genetics which includes direct oversight of all physicians, genetic counselors, dietitians, and clinical research staff involved with the study.
Creates budgets for the clinical trials in coordination with pharma and department operational leaders.
General Responsibilities
Provides highest level of operational leadership and coordination of assigned staff members for clinical research operations and activities; provides direction and guidance on high priority and/or complex clinical research projects/initiatives.
Conducts a variety of personnel actions to include, but not limited to hiring, training, promotion, performance management, and dismissal.
Develops and educates on departmental policies and procedures to ensure the efficient operation of both clinical trials and related patient care; establishes standard operating procedures for clinical research operations/activities and ensures compliance with all internal and external requirements of regulatory agencies.
Evaluates protocol, study design, and assesses risk to subject population. Manages staff assignments and allocation of clinical research resources, including determining staff and facility availability; assesses study population/availability; reviews and critically evaluates study contracts/letters of agreement.
Prepares and negotiates budget; prepares payment schedule with sponsors; negotiates fees for associated services; manages study accounts and ensures that expenditures do not exceed contracted amount and are appropriate/approved.
Oversees and establishes processes/procedures for the proper screening of study subjects; ensures that Informed Consent forms are explained to study participants and all required signatures are obtained prior to start of study.
Establishes, implements, and ensures quality assurance for clinical research operations; seeks peer-review for quality assurance practices that retrospectively evaluates accuracy and timeliness of study completion and/or identifies potential protocol violations.
Communicates with sponsors concerning progress of clinical research, budgetary updates, patient study-related problems or concerns, recruitment strategies and specific policies and procedures.
Acts as liaison between clinical research staff and study sponsors, IRB, federal, state and university officials and other regulatory agencies to maintain regular communication of costs, policy changes, fiscal requirements, and other regulatory issues.
Serves as representative and advisor for clinical research operations on appropriate university committees, work groups and task forces.
Researches and stays up-to-date with new research developments by attending continuing education meetings, lectures, training sessions and/or conferences.
Qualifications
Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.
EDUCATION
Required
Master's degree plus 2 years in clinical research, including supervisory experience OR
Bachelor's degree in science or health-related field plus 4 years of experience in clinical research, including supervisory experience OR
Associate's degree in Allied Health plus 5 years of experience in clinical research, including supervisory experience
LICENSES AND CERTIFICATES
Required
ACRP or SOCRA clinical research certification upon date of hire
SKILLS
Required
Proficient communication skills
Maintains a high degree of professionalism
Demonstrates time management and priority setting skills
Demonstrates a high commitment to quality
Excellent organizational skills
Excellent collaboration and team building skills
Effectively coaches and delivers constructive feedback
Instills commitment to organizational goals
Demonstrates excellent judgment and decision making skills
Effective conflict management skills
Builds and manages effective teams
Working Conditions / Demands
The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.
Additional Information
This position is grant funded with expected annual renewals. Renewals are contingent on the availability of grant funds.
Work Location
IU Indianapolis, Indiana
This position is eligible to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs.
Advertised Salary
$86,220.80 per year - $96,220.80 per year based on experience and internal equity within the department.
Benefits Overview
For full-time staff employees, Indiana University offers a wide array of benefits including:
Multiple plan options for medical insurance
Dental insurance
Health Savings Account with generous IU contribution
Life insurance, LTD, and AD&D options
Base retirement plan contribution from IU, subject to vesting
Additional supplemental retirement plan options
Tuition benefit for IU classes
10 paid holidays per year
Generous Paid Time Off
Paid Parental Leave
Employee Assistance Program (EAP)
Learn more about our benefits by reviewing our online Benefits Brochure.
Job Classification
Career Level: Sr. Operational
FLSA: Exempt
Job Function: Research
Job Family: Clinical Research Click here to learn more about Indiana University's Job Framework.
Posting Disclaimer
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 based on individual qualifications. Indiana University prohibits discrimination based on 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.
Campus Safety and Security
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