Clinical Research Director jobs in New York
Clinical Research Director directs and oversees the clinical research function for a healthcare organization. Develops research studies and creates standards and guidelines for clinical research services and programs. Being a Clinical Research Director ensures adherence to standard operating procedures, good clinical practice and FDA regulations. Requires an advanced degree. Additionally, Clinical Research Director typically reports to top management. The Clinical Research Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. To be a Clinical Research Director typically requires 5+ years of managerial experience. (Copyright 2024 Salary.com)
Recently Added Clinical Research Director jobs
Director of Quality - Atlas Clinical Research (Remote)
- Rochester Clinical Research
-
Rochester, NY
FULL_TIME
-
- Applicants must reside in one of the following states in order to be considered: NY, PA, NC, GA, AZ or FL****
Atlas Clinical Research is a leading Private Equity (PE)-backed clinical research site network, dedicated to transforming the healthcare landscape through innovative research solutions. We envision a world where patients and their families have ready access to groundbreaking new treatments being developed by our sponsors, and made possible through the access, care, and support provided by our therapeutically focused clinical network.
Job Summary
Under the direction of the Sr. VP of Portfolio Delivery, the Director of Quality is responsible for monitoring the quality and consistency of data and clinical operations across the Atlas network. This role will ensure that quality is built into all site and central processes and will partner with operations teams to verify quality outcomes. The Director will assist sites with preparing for and completing audits and inspections. This role will help the company succeed by reinforcing adherence to best-in-class processes, Good Clinical Practice, and federal and local regulations related to clinical research.
Key Responsibilities- Create and maintain new Standard Operating Procedures (SOPs), Work Instructions, and other guidance at the network and site levels in compliance with ICH-GCP and federal, state, and local regulations as applicable.
- Create and oversee the annual Clinical Site Oversight Plan and actions.
- Review and edit existing SOPs, work instructions, and other guidance at the network and site levels for compliance with applicable regulations and conformity to network SOPs.
- Support the development and delivery of network and site-level training events, as requested, in various formats.
- In collaboration with site quality lead, conduct consistent internal risk-based study review activities to ensure compliance with ICH-GCP and applicable regulations.
- Work with the aligned operations team to remediate any issues or noncompliance identified at the site and implement preventive action as appropriate.
- Participate in other requested quality investigations and internal quality improvement initiatives, as assigned.
- Assist site and central operations teams to identify risks and mitigations; categorize, assess for trends and patterns, and identify the root cause of issues; implement, and track Corrective and Preventive Action plans (CAPAs).
- Routinely assess and report to operations on the risks impacting each site.
- Conduct and report on the quality reviews of external sites as part of the Mergers & Acquisitions (M&A) due diligence process.
- Participate in the integration of newly acquired sites into the network according to the integration playbook.
- Oversee audit and inspection readiness activities and share best practices to maintain a constant state of site inspection readiness.
- Attend site inspections and audits, as required; provide updates to internal leadership.
- Track and assist in the required training of site and central employees.
- Support the development and delivery of training materials for site employees (GCP, local and federal regulations, network SOPs, etc.)
- Help site directors assess employee performance to quality standards, particularly in the 90-day probationary period after hire.
- Participate in continuing education opportunities to stay up to date on relevant quality initiatives, regulatory guidance, and industry best practices.
- Bachelor's degree in sciences or related field. (Will consider Associate's degree with 5 years of equivalent experience).
- 3 years of experience in the clinical research industry required.
- 3 years of experience in a clinical quality role (GCP) required.
- Experience developing SOPs required.
- Excellent knowledge of current federal and local regulations on clinical research and GCP.
- Extreme attention to detail.
- Ability to communicate and work effectively with a diverse team of professionals.
- Strong communication and organizational skills.
- Comfortable taking direction from supervisor or working with autonomy.
- Proficient computer skills and use of MS Office.
- Ability to build rapport with employees and external clients.
- Ability to travel up to 20% of the time.
- $85-95K/year
- Applicants must reside in one of the following states in order to be considered: NY, PA, NC, GA, AZ or FL****
- 2 Days Ago
Clinical Research Coordinator I
- Velocity Clinical Research, Inc.
-
Vestal, NY
FULL_TIME
- Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our...
- 5 Days Ago
Clinical Research Coordinator II
- Velocity Clinical Research, Inc.
-
Vestal, NY
FULL_TIME
- Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our...
- 8 Days Ago
Clinical Research Nurse - Buffalo, NY
- Rochester Clinical Research
-
Buffalo, NY
FULL_TIME
- Job Summary: The Clinical Research Nurse works closely with the Principal Investigator managing study conduct from study selection through study closeout. The Clinical Research Nurse is responsible fo...
- 1 Month Ago
Clinical Research Director jobs at Popular Companies
Senior Clinical Research Director
- Sanofi Group
-
Cambridge, MA
- **About the Job** We are an innovative global healthcare company with one purpose: to chase the miracles of science to i...
- 6/11/2024 12:00:00 AM
Clinical Research Director I&I
- Sanofi Group
-
Cambridge, MA
- **About the Job** We are an innovative global healthcare company with one purpose: to chase the miracles of science to i...
- 6/11/2024 12:00:00 AM
Clinical Research Director, I&I
- Sanofi Group
-
Cambridge, MA
- **About the Job** We are an innovative global healthcare company with one purpose: to chase the miracles of science to i...
- 6/11/2024 12:00:00 AM
Director of Clinical Research Consulting
- Vitalief Inc.
-
New Brunswick, NJ
- WHY VITALIEF? Vitalief is an innovative Healthcare consulting company, focused on empowering Research and transforming C...
- 6/10/2024 12:00:00 AM
Principal Clinical Research Director, I&I
- Sanofi Group
-
Cambridge, MA
- **About the Job** We are an innovative global healthcare company with one purpose: to chase the miracles of science to i...
- 6/9/2024 12:00:00 AM
Sr. Director, Procurement - Clinical Research Group
- Thermo Fisher Scientific
-
Morrisville, NC
- Job Description About Thermo Fisher Scientific: When you're part of the team at Thermo Fisher Scientific, you'll do mean...
- 6/9/2024 12:00:00 AM
Clinical Research Director - 219072
- Medix™
-
Franklin, TN
- Role The Clinical Research Director (CRD) is a specialized research professional working with and under the direction of...
- 6/8/2024 12:00:00 AM
Director of Clinical Research
- Eastern Connecticut Hematology & Oncology
-
Norwich, CT
- Director of Clinical Research Opportunity Eastern Connecticut Hematology & Oncology Norwich, CT Job Details: Occupation:...
- 6/7/2024 12:00:00 AM
About New York
New York is a state in the Northeastern United States. New York was one of the original thirteen colonies that formed the United States.
New York covers 54,555 square miles (141,300 km2) and ranks as the 27th largest state by size.[3] The highest elevation in New York is Mount Marcy in the Adirondacks, at 5,344 feet (1,629 meters) above sea level; while the state's lowest point is at sea level, on the Atlantic Ocean.
In contrast with New York City's urban landscape, the vast majority of the state's geographic area is dominated by meadows, forests, rivers, farms, mountains, and lakes. Most of...
Source: Wikipedia (as of 04/17/2019). Read more from Wikipedia
Income Estimation for Clinical Research Director jobs
$153,078 to $206,646
Most Popular Cities in New York for Clinical Research Director Jobs
What does a Clinical Research Director do?
Clinical Research Director in Racine, WI
For those interested in the field or already working in clinical research, here are five reasons why it makes for a brilliant career.
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Clinical Research Director in Winston Salem, NC
In order to address the complex medical and dental issues facing the US and international community, a trained clinical research workforce is critical to ensure that research is aligned with the highest scientific, ethical, and regulatory standards.
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Clinical Research Director in Saint Louis, MO
At UHealth, our dedicated physicians and MSOM researchers offer patients the shortest distance between breakthrough and treatment.
February 09, 2020
Specific to the clinical trials piece, biopharma’s dynamic pipelines and significant cash resources has them in search of people to move their programs along.
January 08, 2020