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- Tasks: Oversee compliance and quality assurance for cancer clinical trials, ensuring adherence to regulations.
- Company: Montefiore Medical Center, a leader in cancer research and patient care.
- Benefits: Competitive salary, supportive work environment, and opportunities for professional growth.
- Why this job: Make a real difference in cancer research while developing your project management skills.
- Qualifications: Bachelor's degree required; 5 years of experience in clinical research preferred.
- Other info: Join a diverse team committed to equal opportunity and impactful healthcare.
The predicted salary is between 60000 - 75000 £ per year.
Overview
City/State: Bronx, New York
Grant Funded: Yes
Department: Cancer Clinical Trials Office
Work Shift: Day
Work Days: MON-FRI
Scheduled Hours: 9 AM-5:30 PM
Scheduled Daily Hours: 7.5 HOURS
Pay Range: $80,000.00-$100,000.00
The Clinical Research Program Manager- Monitor, under the supervision of the Director of Quality Assurance, will provide compliance and quality assurance reviews for the Montefiore Einstein Cancer Clinical Trials Office. The Clinical Research Program Manager- Monitor will be responsible for all ongoing monitoring activities - patient case reviews, pharmacy reviews, regulatory reviews for Montefiore Einstein Cancer Center Investigator Initiated Trials (trials where MECC clinicians are the Sponsor Investigators/IND Holder). The CRM will provide routine reviews and determine if there are compliance concerns that warrant a formal action. The duties of this position must be executed in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), the Montefiore Einstein Cancer Center Data and Safety Monitoring Plan (DSMP), and any other applicable regulatory requirements. The Clinical Research Program Manager- Monitor will work under the direction of the Director, Quality Assurance and will provide constant feedback on findings and evaluation of instituted Corrective and Preventative Action Plans (CAPA). The Clinical Research Program Manager- Monitor will serve as the Administrator for the MECC Data and Safety Monitoring Committee. In addition, the Clinical Research Program Manager- Monitor will work with the Director, Quality Assurance to develop and support an eligibility review process for all patients enrolled on cancer clinical studies.
Responsibilities
- Monitor, under supervision, compliance and quality assurance for Montefiore Einstein Cancer Clinical Trials Office.
- Conduct patient case reviews, pharmacy reviews, and regulatory reviews for Investigator Initiated Trials.
- Perform routine reviews and identify compliance concerns warranting formal action.
- Adhere to Good Clinical Practice (GCP), SOPs, DSMP, and applicable regulatory requirements.
- Provide feedback on findings and evaluate CAPA implementations.
- Serve as Administrator for the MECC Data and Safety Monitoring Committee.
- Develop and support an eligibility review process for all patients enrolled on cancer clinical studies.
Qualifications
- Bachelor's degree required; Master’s degree preferred.
- 5 years of work experience required; minimum of 3 years of experience in clinical research.
- CCRP/CCRC Certification preferred.
- Prior experience with internal audits and/or FDA inspection preparations.
- Demonstrated knowledge of and adherence to federal (FDA, OHRP, GCP, etc.), state, and other regulatory standards related to clinical research.
- Strong working knowledge of ongoing monitoring techniques (including criteria development and trending).
- Strong working knowledge of quality management principles, tools, and risk management techniques.
- Analytical and critical thinking skills to recognize trends.
- Ability to manage projects: prioritize, identify barriers, and meet deadlines.
- Ability to prioritize, organize, plan, and implement services while handling multiple projects/problems simultaneously.
- Demonstrated communication, leadership, and team-building skills, including effective problem solving and motivating others.
- Demonstrated ability to work with minimal supervision.
- Effective written and verbal communication.
Program Manager Clinical Research employer: Montefiore Health System
Contact Detail:
Montefiore Health System Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Program Manager Clinical Research
✨Tip Number 1
Network like a pro! Reach out to folks in the clinical research field, especially those at Montefiore. A friendly chat can open doors and give you insider info about the role.
✨Tip Number 2
Prepare for interviews by brushing up on GCP guidelines and compliance standards. Show us you know your stuff and can handle the responsibilities of the Clinical Research Program Manager role.
✨Tip Number 3
Don’t just wait for job postings; be proactive! Check our website regularly and apply directly through it. This shows initiative and can set you apart from other candidates.
✨Tip Number 4
Follow up after interviews with a thank-you note. It’s a simple gesture that keeps you fresh in our minds and shows your enthusiasm for the position!
We think you need these skills to ace Program Manager Clinical Research
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Program Manager role. Highlight your experience in clinical research and any relevant certifications like CCRP or CCRC. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical research and how your skills can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Compliance Knowledge: Since compliance is key for this role, make sure to mention your familiarity with GCP, SOPs, and regulatory standards. We’re looking for someone who understands the importance of quality assurance in clinical trials.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just a few clicks and you’re done!
How to prepare for a job interview at Montefiore Health System
✨Know Your GCP and SOPs
Make sure you brush up on Good Clinical Practice (GCP) guidelines and Standard Operating Procedures (SOPs) before your interview. Being able to discuss these in detail will show that you understand the compliance and quality assurance aspects of the role.
✨Showcase Your Experience
Prepare specific examples from your past work experience that highlight your skills in clinical research, particularly any internal audits or FDA inspection preparations you've been involved in. This will demonstrate your hands-on knowledge and ability to manage projects effectively.
✨Demonstrate Analytical Skills
Be ready to discuss how you've used analytical and critical thinking skills to identify trends or compliance concerns in previous roles. This is crucial for the position, so having concrete examples will help you stand out.
✨Communicate Effectively
Practice articulating your thoughts clearly and confidently. Since the role requires strong communication and leadership skills, being able to convey your ideas effectively during the interview will leave a positive impression on the hiring team.
