Clinical Research Leader (Project Manager) at Indiana University in Indianapolis, Indiana

Job Description:

Department



HEREDITARY GENOMICS DIVISION (IN-HGN-IUINA)



Department Information



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.



Job Summary



Department-Specific Responsibilities

• Helps execute strategy around patient engagement and recruitment into research studies.


• Develops workflows and oversees a portfolio of projects aimed at contacting research subjects to engage in new study opportunities.


• Works with key leaders across organizations to design and implement workflows to support increased enrollment in research studies.


• Works with external partners to establish workflows to support patient engagement, including pediatrics, and sample collections for research studies.


• Manages staff who consent patients and collect samples for research studies.

General Responsibilities

• 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.

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



Required

• Bachelor's degree preferably in science or health-related field.

Preferred

• Master's degree.

WORK EXPERIENCE



Required

• 2 years of clinical research experience.

Preferred

• Supervisory experience.


• Experience with human subject research.


• Experience working with pediatric populations.

LICENSES AND CERTIFICATES



Required

• ACRP or SOCRA Clinical Research Certification upon date of hire.

Preferred

• Registered Nurse Registered Nurse in the State of Indiana upon date of hire.

SKILLS



Required

• 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.



Work Location



IU Indianapolis


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.



Advertised Salary



$63,777.60 - $73,777.60 per year based on experience and internal equity within the department.



Benefits Overview



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


• 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.



Job Classification



Career Level: Operational


FLSA: Exempt


Job Function: Research


Job Family: Clinical Research


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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 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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