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
Degree in science or a health-related field
2 years of clinical research experience
Combinations of related education and experience may be considered.
LICENSES AND CERTIFICATES
ACRP or SOCRA Clinical Research Certification Upon Hire
Registered Nurse Registered Nurse in the State of Indiana Upon Hire
Proficient communication skills
Maintains a high degree of professionalism
Demonstrated 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.
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.
Beginning with the fall 2021 semester, all Indiana University students, faculty, and staff will be required to be fully vaccinated for COVID-19 as a condition of enrollment / employment.To learn more about this requirement, view ourCOVID-19 vaccine information page .
Equal Employment Opportunity
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About Indiana University Purdue University Indianpolis - IUPUI
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.