Director of Clinical Research (Clinical Research Leader)

Director of Clinical Research (Clinical Research Leader) Indiana University - 4.2 Indianapolis, IN Job Details Full-time 16 hours ago Benefits Paid parental leave Health savings account AD&D insurance Paid holidays Disability insurance Health insurance Dental insurance Flexible spending account Paid time off Employee assistance program Life insurance Retirement plan Qualifications Project team coordination Research design Revenue cycle management Succession planning Contract management Stakeholder engagement Managerial strategic planning Strategic management Contract review Clinical research Operations management Healthcare resource management Research ethical considerations Project planning Faculty collaboration Contract management in healthcare Performance management Master's degree Team development Hiring Supervising experience Policy & process development Managing budgets in a finance role Quality assurance Clinical research compliance Financial operations management Task prioritization Scientific protocols Decision making Laboratory compliance Staff training Quality improvement Conflict management Clinical staff recruitment CLIA regulations Recruiting Organizational skills Healthcare team management Participating in conferences Healthcare financial management Networking through strategic partnership building Patient recruitment Laboratory staff supervision Budget management in healthcare Research regulatory compliance Contract negotiation IRB compliance Research budget management Senior level Strategic partnerships Research and development project management 4 years Associate's degree Cross-functional team management Leadership Communication skills Staffing management Cross-functional communication FDA regulations Time management Staff development Stakeholder management Full Job Description Department

PATHOLOGY AND LABORATORY MED

(IN-PATH-IUINA) Department Information The department of Pathology and Laboratory Medicine defines clinical research as research that involves a patient, the health information of a patient, or the remnants of samples from a patient. Pathology and Laboratory Medicine at Indiana University (IU) is a unique department of approximately 100 clinical faculty members; we reside in the same centralized physical space at the clinical laboratory (IU Health). Laboratory testing is the backbone of healthcare; 70% of the decisions made about patient care involve laboratory data. Job Summary The Director of Clinical Research leads Pathology and Laboratory Medicine at Indiana University School of Medicine (IUSM), guides IU Health System Laboratory Services (IUH), and guides IU Health Medical Group Pathology (IUHMG) through the evolution of clinical research at the intersection of research and clinical operations within IU Health System Laboratory Services. This position reports directly to the Vice Chair of Clinical and Academic Administration, develops strategy, and implements foundational guidelines to elevate and support the integration of research discoveries from bench-to-bedside, whether internally or externally funded. This role continually solves for the natural disconnect that occurs between clinical research and clinical operations. Department-Specific Responsibilities Cultivates partnerships with investigators, clinical faculty, institutes, biobanks, hospitals, and other clinical areas where pathology and laboratory medicine are front and center in patient care Bridges internal operations with the broader base of the health system, customers, namely those wishing to transact clinical research involving the lab Serves as an enterprise business partner to coordinate and align cross-functional clinical research initiatives that involve Pathology and Laboratory Medicine. Gathers and meets with stakeholders in the department, IUSM, IU Health, and Eskenazi Health Uses information garnered to inform the collaborative development of multi-year business plans, including pilot implementations, within the academic healthcare ecosystem Establishes metrics, timelines, and feedback cycles to monitor progress, ensures accountability, and drives continuous improvement as it pertains to clinical research work flowing through the clinical laboratory system Facilitates clinical research efforts that require pathology and laboratory involvement across the laboratory system at IU Health Establishes expectations and processes that start to set the stage for a standardized clinical research experience for the internal clinical research customers of Pathology and Laboratory Medicine Serves as the primary contact for questions and project development related to clinical research that involves Pathology and Laboratory Medicine in the health system Liaises with the tissue banks, biobanks, and other research centers that work directly with Pathology and Laboratory Medicine Serves as a trusted anchor in clinical research, supporting the processes, supporting the people, and maintaining a calm presence as rapid change unfolds Pushes information to the appropriate audience and pulls information from the appropriate audience, so it is available in the problem-solving process Maintains visibility in the clinical research space, relating to external stakeholders and liaising to improve processes Evaluates the current landscape to determine where additional resources may be required Develops a long-range plan for staffing the work related to a successful clinical research operation in Pathology and Laboratory Medicine, including the appropriate organization (IUSM/IUH/IUHMG) to hire the resources Ensures that revenues and expenses are matched according to the organization leveraging the resources Executes agreements for leasing employee effort, space, time on instruments, and other variables involved in research are included in the scope of this role Creates business cases to request net new resources Liaises with IU Health System Laboratory Services Outreach Billing, Pathology research billing, and the associated revenue cycle contacts to map the current billing processes as they relate to clinical research with an end goal of making the billing process smooth, repeatable, trainable, and expedient Oversees the Anatomic Pathology Clinical Research operation consisting of a team of histotechs, a clinical research coordinator, and a slide scanning clerical technician Works with the director of the large invitro-diagnostics operation in Pathology, with long range succession planning in mind, to determine how to best meet the needs of the operation, from a reporting structure and operational standpoint, in perpetuity Serves as the source of truth for the faculty across the department conducting translational/clinical research Ensures continued appraisal of clinical research themes on a national level, adjusts strategy to ensure Indiana University and IU Health are well positioned to tackle obstacles as they present Engages with the clinical research space at a national level 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 contract(s)/letter(s) of agreement Prepares and negotiates budget; prepares payment schedule with sponsor(s); negotiates fees for associated services; manages study account(s) 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, Institutional Review Board (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 / WORK EXPERIENCE

Required Master's degree plus 2 years in clinical research, including supervisory experience; OR Bachelor's degree in science or a 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 Preferred 5 years of related experience in healthcare operations Experience leading/managing projects in cross-functional teams Experience working at an institution of higher education, a large health care system, or with pharmaceutical, biotechnology, or life science organizations

LICENSES AND CERTIFICATES

Required Society of Clinical Research Associates (SOCRA)/Association of Clinical Research Professionals (ACRP) Clinical Research Certification upon date of hire SKILLS Required Proficient written and verbal 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 Preferred Experience leading without authority in highly matrixed environments Willingness and proven ability to work flexibly, stepping outside of immediate role responsibilities and wearing multiple hats where needed Ability to operate in an environment where the answer is not clear and the answer is not prescriptive Knowledge of the major aspects of clinical research that facilitate conversations with stakeholders to develop business plans that mitigate unintended negative operational impacts Knowledge of clinical research operations and deep experience with research regulatory bodies Excellent decision-making, analytical and strong financial management skills are essential to this position Strong project planning/management, communication and presentation skills Understands CLIA, CAP, FDA, IRB, and other regulatory processes involved in clinical research and translational research High level of independent decision making Self-directed problem solving and topic investigation skills that will necessitate collaborative conversations across organizations, departments, and regulatory bodies Demonstrates the ability to work across various scientific research modalities, including NIH funded research, industry funded research, internal grants, and investigator-initiated studies 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. The department will require attendance at national meetings, local events, and other opportunities that present an opportunity to learn in this specialized area. Additional Information All clinical backgrounds are welcome for this position; the ideal candidate may be well served by experience in a patient facing operation. The ideal candidate may not be a laboratorian; nurses and other healthcare experts are well suited for this work. Departmental funding will be available for leadership development in this space. Work Location Indianapolis, Indiana Benefits Overview For full-time staff employees, Indiana University offers a wide array of benefits including: Comprehensive medical and dental insurance Health savings account with generous IU contributions Healthcare and dependent care flexible spending accounts Basic group life insurance paid by IU Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death and dismemberment insurance Base retirement plan with generous IU contributions, subject to vesting Voluntary supplemental retirement plan options Tuition subsidy for employees and family members taking IU courses 10 paid holidays plus a paid winter break each year Generous paid time off plans Paid leave for new parents and IU-sponsored volunteer events Employee assistance program (EAP) Learn more about our benefits by reviewing the IU Benefit Programs 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 opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information. Campus Safety and Security The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at or by visiting IUPD.

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