Clinical Research Team Lead, Regulatory

Job not on LinkedIn

🔥 3 minutes ago

🏈 Ohio – Remote

🏈 Ohio – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 25%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 357 days.
• No salary listed.

Apply Now

Check your resume score

Customize resume + cover letter

Find Similar Remote Jobs

☆ Save☑️ Mark as applied❌ Hide

Report problem

School of Information Technology at the University of Cincinnati

WebsiteLinkedInAll Job Openings

10,000+ employees

📚 Education

👥 B2C

🔬 Science

Education • B2C • Science

School of Information Technology at the University of Cincinnati is an academic institution that focuses on providing education and training in various information technology disciplines. It prepares students for careers in the ever-evolving technology sector through innovative programs and hands-on learning experiences. The School leverages the university's commitment to cooperative education, offering students unique opportunities to gain real-world experience while earning their degrees.

📋 Description

• Guide and direct day-to-day functions of regulatory clinical research professionals supporting disease teams within the Clinical Trials Office • Provide support, direction, and coaching in training, problem resolution, planning, and work assignment delegation • Serve as a subject matter expert for research regulatory activities, procedures, and Good Clinical Practice adherence • Provide input for performance evaluations and serve as a contact for scheduling needs • Provide coverage for direct reports or lower-level staff as needed • Contribute to developing processes, procedures, tools, and training to enhance clinical research activities • Guide team members in managing non-compliant data collection or study activities and resolving future compliance issues • Track research study progress and develop team work-prioritization plans • Work with study sponsors, IRB, and other regulatory offices • Ensure protocols move through the regulatory process toward activation for participant accrual in accordance with institutional and National Cancer Institute requirements • Work collaboratively in a fast-paced, customer-focused environment • Oversee adherence to SOPs, Good Clinical Practice, and FDA regulations • Ensure regulatory information is entered into the Clinical Trial Management System (CTMS) and e-Regulatory System • Work under the supervision of the Clinical Research Manager, UCCC CTO Administrative Director, CTO Medical Director, and Principal Investigators

🎯 Requirements

• Bachelor's Degree • Nine (9) years of relevant education, experience and/or other specialized training can fulfill minimum education and experience requirements • SoCRA, ACRP, CHRC or RAPS as applicable • 5+ years of work experience • Knowledge of clinical research, human subjects research ethics, and IRB procedures • Thorough understanding of Good Clinical Practice guidelines, Code of Federal Regulations, clinical trials monitoring, and regulatory compliance • Strong qualitative skills and knowledge of study design • Knowledge of medical terminology and policies and regulations relevant to oncology clinical trials • Excellent verbal and written communication skills • Ability to interpret and apply University of Cincinnati, UC Health, and federal, state, and local regulations • Ability to manage multiple priorities, organize, and prioritize work to meet deadlines • Experience in risk management regarding study subjects, federal and non-federal sponsors, and regulating bodies • Knowledge of Microsoft Office (Word, Excel, PowerPoint and Outlook) • Satisfactory proof of employment eligibility via the Federal I-9 employment verification process if hired

🏖️ Benefits

• Comprehensive tuition remission for the employee and eligible dependents • Robust retirement plans: OPERS, STRS, or Alternative Retirement Plan (ARP), with UC contributing 14–18% of salary based on position • Vacation and sick time • 11 paid holidays and additional end-of-year paid time off (Winter Season Days) • 6 weeks of paid parental leave for new parents • Competitive salary based on experience • Comprehensive health coverage (medical, dental, vision, prescription) • Flexible spending accounts and wellness programs • Professional development and mentorship opportunities

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume