We have other current jobs related to this field that you can find below
-
Regulatory Affairs Manager in Clinical Research
59 minutes ago
Phoenix, Arizona, United States DocTrials Full timePosition OverviewDocTrials is in search of a skilled Clinical Research Regulatory Manager. This role is ideal for individuals who have a strong commitment to regulatory adherence, effective task management, and the maintenance of excellence in clinical research. As a vital contributor to our organization, you will be responsible for supervising various...
-
Phoenix, Arizona, United States DocTrials Full timePosition SummaryDocTrials is on the lookout for a skilled Clinical Research Regulatory Manager. This role is essential for ensuring adherence to regulatory standards, managing workflows efficiently, and upholding excellence in clinical research practices. As a pivotal member of our organization, you will supervise a variety of regulatory functions and...
-
Clinical Research Coordinator III
2 months ago
Phoenix, United States DM Clinical Research Full timeJob DescriptionJob DescriptionClinical Research Coordinator IIIA CRC III will ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. To ensure study enrollment meets or exceeds Sponsors' expectations. To...
-
Phoenix, Arizona, United States DocTrials Full timePosition OverviewDocTrials is in search of a committed Clinical Research Regulatory Manager who is adept at ensuring regulatory adherence and managing operational tasks effectively. This position is crucial for maintaining the integrity of our clinical research initiatives and aligning them with established industry standards.Primary Responsibilities:Oversee...
-
Clinical Research Regulatory Manager
3 months ago
Phoenix, United States DocTrials Full timeJob DescriptionJob DescriptionSalary: TL;DRAs a Clinical Research Regulatory Manager, you love to-do lists, organization, and are a master of administrative tasks. You have pronounced attention to detail and are obsessed with learning. As a lifelong seeker of knowledge you read everything! Dotting all your i's and crossing all your t's is a top...
-
Clinical Research Coordinator II
2 days ago
Phoenix, United States DM Clinical Research Full timeJob DescriptionJob DescriptionClinic Research Coordinator II The Clinical Research Coordinator II, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study...
-
Clinical Research Regulatory Coordinator
2 months ago
Phoenix, United States DocTrials Full timeJob DescriptionJob DescriptionSalary: Clinical Research Regulatory Coordinator TL;DRAs a Clinical Research Regulatory Coordinator, you love to-do lists, organization, and are a master of administrative tasks. You have pronounced attention to detail and are obsessed with learning. As a lifelong seeker of knowledge you read everything! Dotting all your...
-
Clinical Research Manager
5 days ago
Phoenix, Arizona, United States IRONWOOD PHYSICIANS,P.C. Full timePosition OverviewIronwood Physicians, P.C. is dedicated to providing exceptional cancer care through our state-of-the-art facilities. Our integrated Cancer and Women's Centers offer a comprehensive range of services tailored to meet the unique needs of our patients.Our Mission: To deliver high-quality, comprehensive cancer care that honors the values and...
-
Clinical Research Specialist
4 hours ago
Phoenix, Arizona, United States Phoenix Children's Hospital Full timeJob Overview Position Title: Clinical Research Coordinator Department: RSRCH-GRNT | Genetics Research Studies Location: Phoenix Position Summary This role entails overseeing a range of research initiatives from the initial planning stages to the final closure. The Clinical Research Coordinator will independently manage the collection of specimens, extraction...
-
Clinical Research Project Manager
1 hour ago
Phoenix, Arizona, United States DocTrials Full timeJob OverviewSalary: CompetitiveSummary:As a Clinical Research Project Manager, you excel in multitasking, prioritizing, and ensuring efficiency in all your tasks. Your keen attention to detail makes you the go-to person for your colleagues when they need assistance with their work. You have a passion for analyzing and understanding extensive information....
-
Clinical Research Coordinator
3 weeks ago
Phoenix, United States Phoenix Children's Hospital Full timeJob Description Clinical Research Coordinator Clinical Research Coordinator Apply! Apply! Position DetailsDepartment: RSRCH-GRNT | Pulmonary Research StudiesCategory: ResearchLocation: PhoenixEmployee Type: RegularPosting #: 865681Posted On: 7/30/2024 Position Summary This position is responsible for the coordination of a variety of research projects...
-
Clinical Research Nurse
3 weeks ago
Phoenix, United States Phoenix Children's Hospital Full timeJob Description Clinical Research Nurse Clinical Research Nurse Apply! Apply! Position DetailsDepartment: RSRCH-GRNT | Nephrology Research StudiesCategory: ResearchLocation: PhoenixEmployee Type: RegularPosting #: 863321Posted On: 7/19/2024 Position Summary This position provides and coordinates clinical care for research subjects. This position has a...
-
Clinical Research Nurse
4 weeks ago
Phoenix, United States Phoenix Children's Hospital Full timeJob Description Clinical Research Nurse Clinical Research Nurse Apply! Apply! Position DetailsDepartment: RSRCH-GRNT | Nephrology Research StudiesCategory: ResearchLocation: PhoenixEmployee Type: RegularPosting #: 863321Posted On: 7/19/2024 Position Summary This position provides and coordinates clinical care for research subjects. This position has a...
-
Clinical Research Associate
1 month ago
Phoenix, United States augmentjobs Full timeJob DescriptionJob DescriptionJob Summary: We are seeking a dedicated Clinical Research Associate (CRA) to join our dynamic team. The CRA will play a pivotal role in managing and monitoring clinical trials to ensure compliance with regulatory requirements, study protocols, and quality standards. This position offers an opportunity to contribute to...
-
Clinical Research Specialist
5 days ago
Phoenix, Arizona, United States Phoenix Children's Hospital Full timeJob Overview Position Title: Clinical Research Nurse Department: RSRCH-GRNT | Nephrology Research Studies Location: Phoenix Position Summary This role is pivotal in delivering and managing clinical care for research participants. The Clinical Research Nurse ensures participant safety, maintains informed consent, upholds the integrity of protocol execution,...
-
Clinical Research Specialist
5 days ago
Phoenix, Arizona, United States Phoenix Children's Hospital Full timeJob Overview Position Title: Clinical Research Coordinator Department: RSRCH-GRNT | Genetics Research Studies Location: Phoenix Position Summary This role is pivotal in overseeing a diverse range of research initiatives from initial study setup to final closure. The Clinical Research Coordinator will operate autonomously in gathering specimens, extracting...
-
Clinical Research Specialist
4 hours ago
Phoenix, Arizona, United States Phoenix Children's Hospital Full timeJob Overview Position Title: Clinical Research Coordinator Department: RSRCH-GRNT | Genetics Research Studies Location: Phoenix Position Summary This role is pivotal in overseeing various research initiatives from their inception to conclusion. The Clinical Research Coordinator will operate autonomously in gathering specimens, extracting and entering patient...
-
Jr. Clinical Research Coord
3 weeks ago
Phoenix, United States American Vision Partners Full timeOverview As a Junior Clinical Research Coordinator, you are responsible for assisting with the management and coordination of all aspects of conducting clinical trials within s RII, surgery centers, both clinically and administrative/regulatory. Responsibilities Acts as a representative of clinical research and as liaison between...
-
Neurosurgery Clinical Research Nurse
5 days ago
Phoenix, Arizona, United States Unavailable Full timePosition OverviewWelcome to UnavailableAt Unavailable, we are committed to providing exceptional healthcare services. Our organization is recognized for its dedication to quality patient care and innovative medical research. We pride ourselves on our mission to serve diverse communities and improve health outcomes.We are currently seeking a Clinical Research...
-
Neurosurgery Clinical Research Nurse
5 days ago
Phoenix, Arizona, United States CommonSpirit Health Full timePosition OverviewCommonSpirit Health is dedicated to providing exceptional healthcare services, and we are seeking a skilled Clinical Research Nurse to enhance our Neurosurgery Clinical Research Team. This role is pivotal in managing and coordinating various clinical protocols, ensuring adherence to regulatory standards and promoting the advancement of...
![DocTrials](https://media.trabajo.org/img/noimg.jpg)
Clinical Research Regulatory Manager
1 month ago
TL;DR
As a Clinical Research Regulatory Manager, you love to-do lists, organization, and are a master of administrative tasks. You have pronounced attention to detail and are obsessed with learning. As a lifelong seeker of knowledge you read everything Dotting all your i's and crossing all your t's is a top priority for you. You are a superstar at Word, Excel and organization of electronic documents and files. When faced with a challenge, you grab your resources, open your manuals, and search until the answer can be found You are versed in FDA guidelines and ICH GCP and are always striving to align with best practices. You’re up to date with the latest and greatest regulations in the industry and you ensure updates to processes are implemented company-wide. You don’t shy away from defending our SOPs to make certain we are adhering to them 100% of the time. Problem solving and implementing processes that work are your jam You have a minimum of 1 year clinical research experience. Bachelor's degree required.
What you will own & improve
- Manage Regulatory Compliance Company-wide: Accomplishes regulatory affairs department objectives by selecting, orienting, training, coaching, and disciplining employees. Hires, trains, communicates job expectations and conducts performance evaluations. Oversee staff who support all regulatory tasks and perform quality checks.
- Regulatory Department Task Management: Manages Trial Master File maintenance, IRB reporting, submissions, approval processing, and more. Rolls out protocol and informed consent amendment approvals. Oversee staff who support with these tasks.
- Credentialing: Maintain CVs for all physicians, staff, and study staff members; update appropriately. Track GCP training expirations and issue reminders for completion; file certificates. Maintain current medical malpractice, general liability, and workers compensation documentation for all physicians.
- Calibration & Certifications: Track and manage equipment calibration across all sites including monthly and annual calibration. Schedule and orchestrate annual recalibrations; file certificates. Obtain and maintain laboratory certifications (e.g. CLIA) for each site, track certifications, and apply for renewals.
- Study Start-Up: Acting project manager, taking the study through the start up process to ensure prompt timelines are met. Prompt and accurate execution of initial regulatory packets. Collects training documentation and ensures completion of the delegation of authority log prior to initiation of protocol activities. Ensures the study hits the ground running when green light is received.
- Internal Monitoring & Mock Audits: Conduct thorough quality assurance checks of source and regulatory and provide staff retraining as applicable. Oversee staff who perform these duties. Conduct mock inspections of trials across all sites including those out of state, document findings, conduct reviews with staff, and support in the implementation of CAPA with on-site staff.
- Audit Management: Serve as the point person for Sponsor Audits. Manage pre-audit activities to ensure proper quality assurance of regulatory and source, facilitate pre-audit meetings with staff and doctors, and manage day-of audit activities. Compose audit finding responses, implement corrective action, and conduct retraining based on the audit report.
- SOP Creation & Maintenance: Review SOPs on a regular basis to ensure adherence and update as necessary. Perform SOP review and retraining with staff. Monitor for gaps and create new SOPs where applicable.
- Protocol Deviation Review & Approval: Track, edit, and approve protocol deviation reporting. Observe trends and retrain staff as necessary. Report eligible deviations based on IRB guidelines.
- Sponsor/CRO Monitor Relations: Maintain and develop business relationships with Sponsor/CRO staff. Participate in study acquisition activities including completion of CDAs and Feasibility Questionnaires. Schedule and carry out pre-study visits.
- Study Meetings: You manage all of them with the support of site staff and the regulatory department (PSV, SIV, IMV, COV). Attend Investigators’ Meetings to represent DocTrials and form business relationships with key players.
- Monitor Management: Manage monitor site visits and delegate site staff responsible for facilitating the visit when necessary. Facilitate meetings between Sponsor/CRO representatives and PIs. Track receipt of monitor follow-up letters, execute to do lists, resolve items/queries, and provide follow-up responses to outstanding items.
- Study Close-Out: Manage the QA and archiving process and organization
What you already know and do
- You are a CTMS super user completing tasks within Clinical Trial Management Software (CTMS), eSource, eDocs, and more. You can create and update source as required by protocol amendments, clarification letters, etc.
- Process important study information through the project management platform, Basecamp. Relay information, study bulletins, newsletters, and memos to the team.
- Advanced regulatory and quality assurance skills like how to properly add staff to studies, execute initial regulatory packets in a timely manner, prompt IRB correspondence/submissions, and how to prepare for and carry out successful monitoring visits.
- Moderate knowledge of ICH-GCP and FDA guidelines.
- How to organize and maintain order at the site - manage study supplies, inventory, and ordering.
- How to stay personally organized and manage a large variety of tasks and timelines.
- Possess strong written, verbal and interpersonal skills.
What you will learn
- How to grow a Regulatory and Quality Assurance department packed with internal monitoring processes, inspection team, and regulatory compliance committee.
- How to cultivate a positive working relationship with all of our customers (Sponsor/CRO & Physician Specialists). Further business development by participating in study acquisition activities, identifying study leads, and following up until selection.
About the Team
This role reports to our Director of Clinical Research.
Local travel is required.
Benefits at DocTrials
Competitive salary
Health insurance
Dental & vision
Paid time off
Bonus structure
Cell phone stipend
Mileage reimbursement
Retirement plan
Flexible schedule
Company adventures
Values at DocTrials
Align Your Daily Priorities
Roll Out the Red Carpet
Be obsessed about learning
Show Up Ready
What Can We Do?
Don’t Panic
Don’t Work in a Bubble
Recognize the Gray
Have a positive purpose
About Us
DocTrials' culture is guided by our values and behavior. Our success depends on how much we care for each other, our customers, and our community.
DocTrials is an alliance of physician sites specializing in the conduct of clinical studies within their private practices. Sites in the alliance work under DocTrials' core standard operating procedures and quality control measures that provide a methodology ensuring the highest quality control and best practice utilization across sites. This provides assurance and confidence to sponsors that they will achieve quality data in the most efficient and timely manner. DocTrials was founded with the primary goal of connecting patients and physicians with clinical trials across the US; aiding in the process to discover new therapies, bring hope, and find new treatment for disease.