This position will be responsible to provide operational management and oversight to a team of clinical research staff working on a large scale, grant funded project to increase access to contraception within the state of Indiana (PATH4You, (Pregnancy At a Time that is Happy and Healthy 4 You)). The project will provide outreach across the state and this position will need to develop, plan, and coordinate the establishment and growth of that outreach.
Provides operational leadership and administrative direction for all project activities.
Serves as the main point of contact for the project and with provider and community advisory boards.
Develops and coordinates weekly team meeting agendas and takes notes, as well as keeps track of various action items.
Drafts presentation materials for our project and advisory board meetings (including agendas).
Acts as a 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.
Provides oversight to various learners that "intern" with our project and provide orientation and initial training to all newly hired research staff who will directly report to this position.
Assists with study design, including protocol development, site selection, identification of study population, as well as staff, facility, and equipment availability.
Assigns and coordinates activities of study sites to ensure compliance to protocol, regulatory and standard operating procedures and Good Clinical Practice.
Develops and coordinates project policies and procedures to ensure the efficient operation of both clinical trials and patient care; established standard operating procedures for the clinical research unit and ensures compliance with all internal and external requirements of regulatory agencies.
Monitors enrollment goals and modifies participant recruitment strategy, as necessary.
Oversight of data management for data collection and tracking and/or oversee design of such databases.
Develops solutions to complex problems that impact the timely and accurate conduct of clinical research.
Participates in review of risk assessment. Evaluates the protocol study design and risk to subject population.
Composes and submits continuing review/amendments/close out/protocol deviation/adverse events information as required by regulatory agencies and the Indiana University IRB.
Assists and contributes to budget preparation and ensures adherence to grant sponsors, IRB and university account and grant administration guidelines.
Oversees the proper documentation at close-out as required by sponsor including return or disposal of unused supplies, study summary, evaluation of team efforts and study "drop outs" and other required reports.
Education / Work Experience
Bachelor's degree and two years of clinical research experience.
Combinations of related education and experience may be considered.
ACRP or SOCRA Clinical Research Certification.
Master's degree in healthcare related field. Supervisory experience.
Registered Nurse in the State of Indiana.
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.
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.
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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 .
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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.