More information about the department can be found here.
Children's Health Services Research (CHSR) is seeking a Clinical Research Leader. The Clinical Research Leader provides operational management, oversight, and guidance for the research staff within the division. This position collaborates 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 design.
Directly manages all administrative program requirements to ensure continued and future funding.
Develops standard operating procedures.
Oversees vendor negotiations and contracts.
Onboards students and other temporary learners.
Provides first-line problem solving for program/project operations and staff.
Provides direction to faculty and research staff in order to solve complex problems, meets project milestones, and troubleshoots potential barriers to project success which may require reassigning tasks and allocating resources appropriately among staff.
May assist research project leads to develop/draft study protocols, participant tracking systems, informed consent forms, and other project-specific documentation.
Leads meetings to help identify and solve program and staff issues while exercising good judgment regarding when to involve faculty in decision making.
Establishes working relationships with division leadership (including Division Chief, Division Administrator, and other faculty leaders) to assist in strategic planning and operational efforts.
Assists faculty with interviewing and hiring staff, reviewing staff performance, and assigning workload.
Develops solutions to improve recruitment and data entry.
Orients and trains all newly hired staff.
Tracks and records completion of all research and hospital compliance procedures, including CITI training, hospital credentials, immunizations, and liability forms.
Manages staff schedules; reviews and approves bi-weekly timesheets.
Develops professional development opportunities for division research staff including monthly staff learning opportunities and providing monthly updates to division's clinical research staff on policy, regulatory, or other updates.
Establishes short-term operational objectives.
Identifies operational issues and/or areas of improvement and implements solutions to improve processes and/or operational efficiency.
Provides direct supervision and oversight of assigned staff and activities; impacts, and is held accountable for, the performance of team and/or assigned staff.
Ensures and provides training to assigned staff to improve user support operations; researches and identifies development opportunities for assigned staff.
Keeps next-level leader(s) informed of trends as well as significant problems.
Provides operational leadership and administrative direction for clinical research activities.
Analyzes, monitors, and evaluates performance of assigned staff; establishes work priorities, provide 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 and 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, 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 keeps abreast with new research developments by attending continuing education meetings, lectures, training sessions, and conferences.
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.
Bachelor's degree (preferably in science or health-related field)
2 years clinical research experience
LICENSES AND CERTIFICATES
ACRP or SOCRA Clinical Research Certification upon date of hire
Registered Nurse in the state of Indiana upon date of hire
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 / 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.
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.
$75,000 - $85,000 per year
For full-time staff employees, Indiana University offers a wide array of benefits including:
Multiple plan options for medical 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.
Career Level: Operational
Job Function: Research
Job Family: Clinical Research Click here to learn more about Indiana University's Job Framework.
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.
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