Job Info
Department
PED-COMPARATIVE EFFECTIVENESS (IN-PCER-IUINA)
Job Summary
The Division of Pediatric Comparative Effectiveness Research is seeking a Research Operations Manager. This position is responsible for strategic and planned operational management in the conduct and implementation of multiple Center research and educational programs and efforts.
Department Specific Responsibilities
- Provides operational management, oversight, and guidance for programs and projects primarily directed by the Center Director and selected faculty.
- Requires collaborating with university faculty, principal investigators and co-investigators to manage both research and educational programs and includes conducting program-specific quality improvement and enhanced program and project designs.
- Oversees training and supervising staff, approving timesheets, provide fiscal management for research projects and programs, directly manage all administrative program requirements to ensure continued and future funding, developing standard operating procedures, and overseeing vendor negotiations and contracts.
General Responsibilities
- Provides operational leadership and administrative direction for clinical research activities.
- Analyzes, monitors, and evaluates performance of assigned staff; establishes work priorities, provides training, conducts performance reviews, and provides corrective action as needed.
- Ensures adequate staffing and effective scheduling; participates and informs employment decisions for assigned staff.
- Develops and coordinates departmental policies and procedures to ensure the efficient operation of both clinical trials and patient care; establishes standard operating procedures for the clinical research unit and ensures compliance with all internal and external requirements of regulatory agencies.
- Evaluates protocol, study design, and assesses risk to subject population; monitors enrollment goals and modifies participant recruitment strategy, as necessary.
- Oversees and ensures the implementation of the Principal Investigator's recommendation for adverse event interventions; ensures that serious adverse events are reported to sponsor and IRB and properly documented on source documents.
- Designs and implements proper data management for data collection and tracking and/or oversee design of such databases.
- Oversees the proper documentation at close-out as required by sponsor including return or disposal of unused supplies, reconciliation of test article accountability, study summary, evaluation of team efforts, and study ""drop outs"" and other required reports.
- Assists and contributes to budget preparation and ensures adherence to grant sponsors, IRB and, university accounting and grant administration guidelines.
- Acts as liaison between the research staff and the sponsors, IRB, federal, state and university officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues
- Expands knowledge base and keep abreast with new research developments by attending continuing education meetings, lectures, training sessions and conferences
QualificationsEDUCATION
Required - Bachelor's degree (preferably in science or health-related field)
Preferred WORK EXPERIENCE
Required - 2 years clinical research experience
Preferred Combinations of related education and experience may be considered LICENSES AND CERTIFICATES
Required - ACRP or SOCRA Clinical Research Certification Upon date of Hire
Preferred - Registered Nurse Registered Nurse in the State of Indiana 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
Working Conditions / DemandsThe 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 InformationThe salary range for this position is $70,000 - $80,000 annually. Salary determination is based on experience, skill level, education, and training.
Benefits OverviewFor 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 ClassificationCareer Level: Operational
FLSA: Exempt
Job Function: Research
Job Family: Clinical Research
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Posting DisclaimerDue 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.
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New employees will be provided with information regarding Indiana University's COVID-19 vaccine policy, which includes the opportunity to request an exemption. To learn more, view our COVID-19 vaccine information page.Equal Employment OpportunityIndiana 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.
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Telephone: 812-856-1234
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