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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

Arkansas Children’s (https://www.archildrens.org/about-us) is the only hospital system in the state dedicated to caring for children, which enables us to uniquely shape the landscape of pediatric care in Arkansas.

Arkansas Children’s is driven by four core values—safety, teamwork, compassion and excellence—which inform every action.

Arkansas Children’s Hospital has received Magnet Status (https://www.archildrens.org/about-us/magnet-recognition) from the American Nurses Credentialing Center (ANCC), for nursing excellence and patient outcomes. And we are nationally ranked by U.S. News & World Report (https://www.archildrens.org/about-us/awards-and-recognition) for Cancer, Cardiology & Heart Surgery, Diabetes & Endocrinology, Nephrology, Neurology & Neurosurgery, Pulmonology & Lung Surgery and Urology.

For more than a century, Arkansas Children’s has met the unique needs of children. But we’re more than just a hospital treating sick kids—our services include two hospitals, a pediatric research institute, foundation, clinics, education and outreach, all with an unyielding commitment to making children better today and healthier tomorrow.

Arkansas Children’s Little Rock campus includes a 336-bed hospital with the state’s only pediatric Level 1 Trauma Center, burn center, Level 4 neonatal intensive care and pediatric intensive care, as well as a nationally-recognized transport service. And Arkansas Children’s Northwest (https://www.archildrens.org/locations/arkansas-childrens-nw) provides inpatient and emergency care, clinic rooms and diagnostic services to children in that corner of the state.

_“Arkansas Children’s is a place of hope and comfort for children and parents. When you are at children’s, you are part of an elite team united with a common goal of saving children and making their lives better.”_ Michael – Business Operations Manager

•Arkansas Children’s Hospital is a prestigious institution that cares for children.” Linda – Information Systems Analyst

•We are an organization of care, love, and hope while we champion children.” Angela – Parking and Fleet Coordinator

•Care, love, and hope for children!” Kathy – Administrative Assistant

•When I think of my time here at Arkansas Children’s Hospital, I can honestly say that it has given me a unique perspective on the human condition, and the various roles that we all have in patient care. As a supply assistant, I have a very important job ensuring that the doctors and nurses have what they need to provide the world class medical care to the Children of Arkansas and surrounding states. Being a Champion for Children is more than a catch phrase, it is a way of life!” Nick – Supply Assistant

Arkansas Children's provides equal employment opportunity to all persons without regard to age, race, color, religion, national origin or citizenship status, disability, military status, sexual orientation, gender identity or expression, pregnancy or any other category protected by federal, state and local laws. Further, Arkansas Children's will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.