Job Details

Job Title & Specialty Area: Manager Research Operations

Department: Clinical Research

Location: This position supports both Dallas and Plano, some travel will be required

Shift: Day

Job Type: On-Site

Why Children's Health?
At Children's Health, our mission is to Make Life Better for Children, and we recognize that their health plays a crucial role in achieving this goal.

Through our cutting-edge treatments and affiliation with UT Southwestern, we strive to deliver an extraordinary patient and family experience, ensuring that every moment, big or small, contributes to their overall well-being.

Our dedication to promoting children's health extends beyond our organization and encompasses the broader community. Together, we can make a significant difference in the lives of children and contribute to a brighter and healthier future for all.

The Manager of Research Operations position will serve to mitigate risks, and ensure regulatory compliance, operational efficiency and high-quality integrative patient care in support of the increasing demands in the hematology/oncology research field.

A dedicatedManager of Research Operationswill ensure streamlined oversight and support for trials, improving activation timelines, enrollment performance, and data integrity. This role will oversee quality assurance processes, staff training, and continuous improvement, managing to evolving regulatory and safety standards.

The Manager of Research Operations will provide critical oversight of protocol adherence, trial activation, subject enrollment, data integrity, and compliance of Good Clinical Practice (GCP) and FDA regulations. This role will serve as a liaison between the hematology/oncology clinical research office and UTSW Department of Pediatrics research staff, principal investigators, sponsors, regulatory bodies, and internal departments, ensuring that timelines are met, and trials are conducted ethically and efficiently.

Specifically, this role will assist the Director with investigational drug management, regulatory requirements, and multidisciplinary coordination (e.g., pathology, cardiology, ophthalmology, Carter Blood Care, radiology, etc.) to include but not limited to the following:

1.Supervisor to at least 6 Direct Reports

2.Manage day-to-day operations and staff assignments

3.Standard Operating Procedures (SOPs) - revise and create new

4.Training curriculum (new and ongoing), educational activities, presentations

5.Manage the Clinical Research Workload Tool (CRWT) [Coordinator Workload]

6.Physician liaison between (Coordinators, pharmacy, lab, and other allied health partners)

7.Creation of job and process manuals

8.Oversee SharePoint utilization and document retention

9.Manage study feasibility assessments, related activities

10.Assist Director w/ the following:

a.Operationalizing new initiatives and project management

b.Policy review, best practices, compliance

c.Audit Readiness activities (e.g., FDA, COG, CIBMTR, Joint Commission)

d.Plano research activities

e.Liaison to UTSW research partners on budgets, coverage analyses, contracts, billing, problem-solving, IRB, etc.

11.Manage sponsor representative/ study monitor onsite and remote access requests

12.Track metrics and manages to enrollment goals

13.Special tasks (home health, Carter Blood Care, international patients, etc.)

This role will be pivotal in supporting the Director for investigator-initiated trials, academic-industry partnerships, and expansion into new therapeutic areas, including study feasibility, resource allocation, and cross-departmental collaboration, thus directly contributing to the division's growth and reputation.

WORK EXPERIENCE

* At least 5 years of relevant experience in clinical research required

EDUCATION
* Four-year Bachelor's degree or equivalent experience required
* Graduate or professional work or advanced degree; or equivalent experience preferred

LICENSES AND CERTIFICATIONS
* Basic Life Support for Healthcare Providers as required by CP 1.20 Life Support Course Requirements preferred
* CCRC, CCRP or CRN Certification 1 year required

A Place Where You Belong

We put our people first. We welcome, value, and respect the beliefs, identities and experiences of our patients and colleagues. We are committed to delivering culturally effective care, creating meaningful partnerships in the communities we serve, and equipping and developing our team members to make Children's Health a place where everyone can contribute.

Holistic Benefits – How We'll Care for You:

· Employee portion of medical plan premiums are covered after 3 years.

· 4%-10% employee savings plan match based on tenure

· Paid Parental Leave (up to 12 weeks)

· Caregiver Leave

· Adoption and surrogacy reimbursement

As an equal opportunity employer, Children's Health does not discriminate against employees or applicants because of race, color, religion, sex, gender identity and expression, sexual orientation, age, national origin, veteran or military status, disability, or genetic information or any other Federal or State legally-protected status or class. This applies to all aspects of the employer-employee relationship including but not limited to recruitment, hiring, promotion, transfer pay, training, discipline, workforce adjustments, termination, employee benefits, and any other employment-related activity.