Medical Staff Team Lead - Indianapolis, United States - Indiana University

Description

CLINICAL GENETICS (IN-CLNG-IUINA)One of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at IU School of Medicine has a rich history of training geneticists and genetic counselors and providing genetic consultation and counseling services.

The department contributes to the understanding of numerous genetic conditions through the integration of basic research in genetic and genomic mechanisms, translational research in disease models, and clinical trials in rare and common genetic diseases.

The Department of Medical and Molecular Genetics currently manages 20+ clinical trials.

Develops study-specific process guides, nursing orders, and source documentation; meets routinely with study team to manage progress of subjects and studies.

Manages clinical trial studies for the Department of Medical and Molecular Genetics which includes direct oversight of all physicians, genetic counselors, dietitians, and clinical research staff involved with the study.

Creates budgets for the clinical trials in coordination with pharma and department operational leaders.

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; manages study accounts and ensures that expenditures do not exceed contracted amount and are appropriate/approved.

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, 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.
Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.
Master's degree plus 2 years in clinical research, including supervisory experience

ORBachelor's degree in science or health-related field plus 4 years of experience in clinical research, including supervisory experience

ORAssociate's degree in Allied Health plus 5 years of experience in clinical research, including supervisory experienceACRP or SOCRA clinical research certification upon date of hire

Demonstrates time management and priority setting skillsDemonstrates a high commitment to qualityExcellent collaboration and team building skillsEffective conflict management skillsBuilds and manages effective teamsThe 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 grant funded with expected annual renewals. Renewals are contingent on the availability of grant funds.

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.

For 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~ Base retirement plan contribution from IU, subject to vesting~ Additional supplemental retirement plan options~ 10 paid holidays per year~ Employee Assistance Program (EAP)

Learn more about our benefits by reviewing our online Benefits Brochure.
Clinical ResearchTo guarantee full consideration, please submit your application within 5 business days of the Posted Date.

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.

Questions or complaints regarding Title IX may be referred to the U.Department of Education Office for Civil Rights or the university Title IX Coordinator.

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