ARKANSAS CHILDREN'S IS A TOBACCO FREE WORKPLACE. FLU VACCINES ARE REQUIRED. ARKANSAS CHILDREN'S IS AN EQUAL OPPORTUNITY EMPLOYER. ALL QUALIFIED APPLICANTS WILL RECEIVE CONSIDERATION FOR EMPLOYMENT WITHOUT REGARD TO RACE, COLOR, RELIGION, SEX, SEXUAL ORIENTATION, GENDER IDENTITY OR EXPRESSION, NATIONAL ORIGIN, AGE, DISABILITY, PROTECTED VETERAN STATUS OR ANY OTHER CHARACTERISTIC PROTECTED BY FEDERAL, STATE, OR LOCAL LAWS.

This position has been designated as safety sensitive and cannot be filled by a candidate who is a current user of medical marijuana.

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Work Shift:

Please see job description for details.

Time Type:

Full time

Department:

CC033020 Clinical Research Operations

Summary:

The Study Start-Up Project Manager serves as the institutional lead and subject matter expert for the clinical research start-up process. This role is responsible for overseeing and coordinating all activities related to the initiation of clinical research studies, from feasibility assessment through site activation and enrollment readiness.

The Study Start-Up Project Manager will monitor the progress of all research studies in the start-up phase, drive continuous process improvements to enhance efficiency and reduce activation timelines, and leverage data-driven insights through key performance metrics to optimize decision-making.

The Study Start-Up Project Manager will:

• Provide strategic leadership and oversight of the study start-up process, ensuring the timely activation of clinical studies while maintaining compliance with institutional, state, and federal regulations. Establish and drive operational strategies to optimize study activation efficiency
• Act as the primary liaison for study start-up at ACRI, ensuring seamless collaboration between investigators, study teams, and institutional stakeholders. Implement communication strategies to enhance transparency and streamline decision-making.
• Develop and oversee a data-driven approach to study start-up by establishing key performance indicators (KPIs), tracking milestones, and proactively addressing bottlenecks to drive continuous improvement.
• Develop and implement process improvements and best practices to optimize study activation timelines.
• Maintain accurate records of study start-up metrics and generate reports for leadership and stakeholders.
• Provide training and guidance to study teams on start-up procedures, regulatory requirements, and institutional workflows.
• Collaborate with other departments, including regulatory affairs, clinical operations, finance, and hospital service lines, to enhance coordination and efficiency of the study intake and approval process
• Lead risk assessment and mitigation strategies for study start-up, ensuring proactive identification and resolution of challenges that could impact study activation and implementation.
• Coordinate and oversee the coverage analysis and budget development process, ensuring financial feasibility and compliance with institutional policies

Additional Information:

Required Education:

High school diploma or GED or equivalent

Recommended Education:

Bachelor's degree in a related field of study.

Required Work Experience:

High School Diploma/GED and 4 years of relevant experience, or 6 years of experience in lieu of a diploma/GED.

Recommended Work Experience:

Required Certifications:

Recommended Certifications:

Description

1. Manage program/project implementation and assists with monitoring research projects by meeting regularly with PI and study team members and obtaining feedback on project progress.

2. Develop and maintain operational support databases and program management tools.

3. Provides support for program-level data collection, entry, analysis, and communication.

4. Leads and/or assists in preparation of annual and periodic data reports for program and projects.

5. Maintains current and complete manual of procedures, standard operating procedures and other relevant documentation.

6. Oversee and ensure compliance with all pertinent regulatory requirements for the program activities.

7. Assists in the development and submission of grant proposals.

8. Participates in the development (including writing, editing and/or formatting) of abstracts, posters, presentations, reports and publications.

9. Provide support with administrative tasks such as scheduling, developing presentations, document development, event planning, marketing and communications (website maintenance and newsletter).

10. Other duties as assigned