Overnight Trial Master File Jobs in Alabama (NOW HIRING)

Primary Location

MOB - 3430 Burnet

Department

DDBP

Shift

Day (United States of America)

Schedule

Full time

Weekly Hours

40

FTE

1

Employee Status

Regular

*Expected Starting Pay Range

$74,297.60 - $94,744.00

*Starting pay is based on experience, skills, and equity; exceptions may apply for highly qualified candidates. Additional pay (e.g., shift, oncall, or weekend differentials) and benefits may apply.Annual pay may vary based on FTE status.

JOB RESPONSIBILITIES

• Study Conduct/ Clinical Research Practice -Serve as a resource for others for all aspects of conducting a clinical trial for complex and multi-center trials. Develop & implement associated projects related to studies under the guidance of the principal investigator. Collaborate effectively with others to ensure proper progress & completion of studies. Assist other members by educating, providing resources, & consulting on difficult protocols or projects. Indirectly (or directly) supervise other CRCs. Train new staff in preparation & conduct of clinical trials. Provide oversight and guidance as needed to research staff. Collaborate on multiple projects or studies, and support other staff or the work flow involved in research work. Provide oversight and guidance to research staff for all aspects of conducting a clinical trial for complex and multi-center trials. Collect and process specimens to meet study requirements. Work with other divisions as needed to ensure proper handling, processing, storage and tracking of specimens per study requirements.

• Regulatory Compliance and Documentation -Coordinate complex regulatory activities & periodic internal self-audit of records. May lead staff in regulatory activities. Provide oversight for the preparation, review, submission and maintenance of regulatory activities/submissions, ensure accuracy and timeliness to all collaborative parties. Provide oversight and guidance for project procurements. Coordinate and participate in monitor visits, audits, and quality reviews (internal and external) in a professional manner. Organize the review, correspondence and approval of human research protocols with all regulatory authorities, including study closeout. Determine which research protocols or issues have additional requirements, i.e. review by additional CCHMC Divisions, regulatory agencies, or consultants, and coordinate the process to meet these requirements. Act as a resource for regulatory affairs. Apply federal regulations; state and local law; and CCHMC and division policies and standard operating procedures (SOPs) to promote ethical practices in research involving human participants and to ensure compliance to those regulations. Ensure the documentation of regulatory activities in appropriate systems. Coordinate and maintain up-to-date and accurate written and electronic records and files.

• Recruitment/Enrollment/Retention -Prepare study staff for recruitment/enrollment for medium to large/complex complexity projects. Oversee study staff performance. Proactively take initiative to ensure recruitment stays on track with the project time-lines. Implement successful plan to identify potential participants. Engage study staff to assist in identifying and enrolling participants. Proactively identify and monitor barriers to recruitment and problem-solve or innovate to overcome them. Determine best method/s to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly. Create and maintain a detailed tracking system for participants considered for enrollment. Track progress at regular intervals and report out to PI and or management.

• Data Management -Oversee data entry and validation to ensure accuracy, quality and compliance of data collection process. Create case report forms (CRFs) in consultation with other team members, as needed, using existing study data information to promote efficient data collection and data entry. Create Data Dictionary, as per protocol and in conjunction with principal investigator and statistician. Support the data-management process for clinical research projects, including addressing data queries from data managers, project statistician, and sponsors. Maintain and audit data, providing status and activity reports as required. Organize data to analyze, identify, and report trends. Review reports, tables, and listings. Assist in data analysis and maintain record keeping and data storage for clinical research studies. Maintain master database files for clinical research protocols. Prepare reports from validation studies of clinical research projects. Evaluate and resolve issues regarding contents of reports. Ensure quality of data submitted from study sites and assure timely submission of data. Oversee the processing of laboratory and other external data.

• Advancement Reviewer -Serve as a regularly participating reviewer in the advancement process as established by the advancement ladder materials.

JOB QUALIFICATIONS

• Bachelor's degree in a related field

• 7 years of experience in related job discipline OR Master's degree and 6 years experience

• Cert Clinical Research Coord within 18 months of external hire

At Cincinnati Children's, we come to work with one goal: to make children's health better. We believe in a holistic team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better and find energy and inspiration in our shared purpose. If you want to be the best you can be, you can do it at Cincinnati Children's.

Cincinnati Children's is:

• Recognized by U.S. News & World Report as atop 10 best Children's Hospitals in the nation for more than 15 years

• Consistently among the top 3 Children's Hospitals for National Institutes of Health (NIH)Funding

• Recognized as one of America's Best Large Employers (2025), America's Best Employers for New Grads (2025)

• One of the nation'sAmerica's Most Innovative Companiesas noted by Fortune

• Consistently certified as great place to work

• A Leading Disability Employeras noted by theNational Organization on Disability

• Magnet designated for the fourth consecutive time by theAmerican Nurses Credentialing Center (ANCC)

We Embrace Innovation-Together. We believe in empowering our teams with the tools that help us work smarter and care better. That's why we support the responsible use of artificial intelligence. By encouraging innovation, we're creating space for new ideas, better outcomes, and a stronger future-for all of us.

Comprehensive job description provided upon request.

Cincinnati Children's is proud to be an Equal Opportunity Employer committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/Veteran/Disability