Clinical Research Leader Jobs

HEMATOLOGY/ONCOLOGY (IN-HEMO-IUINA)

• Evaluates protocol, study design, and assesses risk to subject population; monitors enrollment goals and modifies participant recruitment strategy, as necessary.
• 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.
• Analyzes, monitors, and evaluates performance of assigned staff; establishes work priorities, provides training, conducts performance reviews, and provides corrective action as needed.
• Designs and implements proper data management for data collection and tracking and/or oversee design of such databases.
• Expands knowledge base and keep abreast with new research developments by attending continuing education meetings, lectures, training sessions and conferences
• 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.
• 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
• Ensures adequate staffing and effective scheduling; participates and informs employment decisions for assigned staff.
• Provides operational leadership and administrative direction for clinical research activities.
• Assists and contributes to budget preparation and ensures adherence to grant sponsors, IRB and, university accounting and grant administration guidelines.
• 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.

EDUCATION

Required

• Bachelor's degree

Preferred

• Master's degree
• Degree in science or health-related field

Work Experience

Required

• 2 years of clinical research experience

Preferred

• Supervisory experience

Combinations Of Related Education And Experience May Be Considered

LICENSES AND CERTIFICATES

Required

• ACRP or SOCRA Clinical Research Certification upon date of hire

Preferred

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

Skills

Required

• Demonstrates a high commitment to quality
• Excellent collaboration and team building skills
• Effectively coaches and delivers constructive feedback
• Instills commitment to organizational goals
• Excellent organizational skills
• Demonstrated time management and priority setting skills
• Proficient communication skills
• Maintains a high degree of professionalism

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.

For full-time staff employees, Indiana University offers a wide array of benefits including:

• Life insurance, LTD, and AD&D options
• Tuition benefit for IU classes
• Employee Assistance Program (EAP)
• Health Savings Account with generous IU contribution
• Multiple plan options for medical insurance
• Additional supplemental retirement plan options
• Generous Paid Time Off
• Base retirement plan contribution from IU, subject to vesting
• Paid Parental Leave
• Dental insurance
• 10 paid holidays per year

Learn more about our benefits by reviewing our online Benefits Brochure.

Career Level: Operational

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research

Click here to learn more about Indiana University's Job Framework.

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.

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.

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 [email protected] or by visiting IUPD.

Request Support

Telephone: 812-856-1234