Specialist - Regulatory
2 months ago
About thejob
Velocity Clinical Research isan owned and integrated research site organization providingexcellence in patient care high quality data and fully integratedresearch sites. At Velocity we align our values and behaviors togive our employees the best chance of delivering on our brandpromise to bring innovative medical treatments to patients. We arecommitted to making clinical trials succeed by generating highquality data from as many patients as possible as quickly aspossible while providing exemplary patient care at everystep.
As an employee of Velocity you are themost integral part of our mission. For talented candidates whoperform at a high level Velocity will invest to support careeradvancement and reward performance. Whether you are new to clinicalresearch or are an industry veteran we invite you to apply toVelocity.
Benefits include medical dental andvision insurance paid time off and company holidays 401(k)retirement plan with companymatch and an annual incentiveprogram.
Summary
The Regualtory Specialist I prepares and maintainscomplete and accurate regulatory documents in support of clinicalresearch studies.
RoleResponsibilities
- Prepare each study specific protocol informed consent form HIPAAauthorization and other related documents for review by theIRB.
- Supports initial regulatory submissiondocuments for IRB and sponsors to ensure site meets regulatoryreadiness metrics with a focus on expedited study startup
- Ensures regulatory submissions are done ina timely manner as to not delay study start up
- Prepare and submit amendments yearly requests for continuingapproval of open protocols audits deviations adverse event reportsand any other IRBrequired submissions.
- Workwith staff members to complete Financial Disclosure Forms for eachstudy.
- Assist new hires in completing andsubmitting all required research documentation and trainings bytheir deadlines.
- Assist coordinators and siteleadership in tracking the training status for existing staffassisting with updates as needed.
- Assistcoordinators in ensuring that all staff on the delegation ofauthority logs have the appropriate training onfile.
- Maintain study binder paper orelectronic as appropriate with all IRB related documents andcorrespondence for each study to ensure audit readiness at alltimes.
- Notify staff and Site Manager/Directorof upcoming training expiration dates
- Assistsite leadership and coordinators in the preparation for monitoringvisits sponsor audits and regulatory audits by conducting qualitychecks of the regulatory binder.
- Assist withthe preparation and submission of closeout documents to thesponsors and IRBs including ensuring completeness auditreadinessand closure of the regulatory binder and appropriate archival oftrial data.
- Supports maintenance oof DOA logsand any other required logs as needed
- Submitor support SAE and AE submissions to the IRB as needed and in atimely fashion
- Supports audit and inspectionreadiness by ensuring accurate and timely filecompletion.
- Provide copies of IRB documents tosponsors as needed.
- Adhere to safety andcompliance regulations.
- Other duties asassigned
Education/Experience
- Bachelors degree with 1 year of relevantexperience in the life science industry OR
- Associates degree with 2 years of relevant experience in the lifescience industry OR
- High School Graduateand/or technical degree with minimum of 3 years relevant experiencein the life science industry
Required Skills
- Demonstrated knowledge of medicalterminology
- Demonstrated ability to use thefollowing technology Computers Microsoft Office software fax copierand multiline telephone.
- Demonstrated verbalwritten and organizational skills
- Demonstratedinterpersonal and communication skills
- Demonstrated ability to work as a team player
- Demonstrated ability to read write and speakEnglish
- Demonstrated ability tomultitask
- Demonstrated ability to followwritten guidelines
- Demonstrated ability towork independently plan and prioritize with someguidance
- Demonstrated ability to beflexible/adapt according to the needs of the clinicpriortization
- Must be detailoriented
- Proficient ability to acceptindividual responsibility for actions taken and demonstrateprofessionalism when judged critiqued and/orpraised
- Demonstrated understanding of ICH GCPand FDA regulatoryrequirements
Lifelancer( ) is a talenthiring platform in Life Sciences Pharmaand IT. The platform connects talent with opportunities in pharmabiotech health sciences healthtech data science and ITdomains.
Please use the below Lifelancer linkfor job application and quickerresponse.
/jobs/view/409d5511e48f122e2f75d7d9284278f5
RemoteWork :
No
-
Regulatory Affairs Specialist
4 months ago
Hyderabad, India Makro Full timeJob Title: Regulatory AffairsSpecialistCompany:MakroCareLocation:Hyderabad Telangana(Onsite)CompanyDescription:MakroCare is aleading provider of regulatory and clinical development solutionsbased in Hyderabad Telangana. We specialize in offeringcomprehensive services in clinical research regulatory submissionsand scientific communication. Our team is...
-
Regulatory Affairs Specialist.
4 months ago
Hyderabad, India Medtronic Full timeCareers that Change Lives Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations.Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met.Responsible for supporting the needs of the MEIC with regulatory support for research and...
-
Contract Specialist
2 weeks ago
Hyderabad, India Tekgence Inc Full timeJob Title:-CONTRACT SPECIALISTExperience:-3 YearsLocation:-HyderabadJob Description:-A Contracts Specialist is a professional who drafts and reviews contractual agreements between companies and suppliers of products or services.Contracts Specialist responsibilities include:Negotiating contract agreements for products and servicesAssessing contractor...
-
Research And Development Specialist
2 months ago
Hyderabad, India Flychem Full timeJob Title: Research and Development SpecialistLocation: Hyderabad Job Summary:We are seeking an experienced Research and Development Specialist with a minimum of 10 years of expertise in drug delivery systems, pharmaceutical ingredients, nanotechnology, regulatory affairs, and patent preparation. The ideal candidate will be responsible for leading R&D...
-
Research And Development Specialist
2 months ago
Hyderabad, India Flychem Full timeJob Title: Research and Development Specialist Location: Hyderabad Job Summary: We are seeking an experienced Research and Development Specialist with a minimum of 10 years of expertise in drug delivery systems, pharmaceutical ingredients, nanotechnology, regulatory affairs, and patent preparation. The ideal candidate will be responsible for leading R&D...
-
Payroll Specialist
4 days ago
hyderabad, India Gamlaa Full timeWe are seeking an experienced Senior Payroll Specialist/Payroll Manager to lead our payroll operations at Gamlaa. The ideal candidate will have at least 18 months of hands-on experience with Keka Payroll, ensuring accurate and timely payroll processing. Responsibilities include managing the full payroll cycle, statutory compliance, employee data, and...
-
hyderabad, India WELLS FARGO BANK Full timeAbout this role:Wells Fargo is seeking a Business Accountability Specialist to join the CIB Global FrontLine Risk Program Execution Team. The Global Front Line Risk Program Execution is a function within the CIB COO - Risk Programs pillar. The team has the key focus to maintain, operate and deliver core front line risk and compliance programs and adopt a...
-
hyderabad, India WELLS FARGO BANK Full timeAbout this role: Wells Fargo is seeking a Business Accountability Specialist to join the CIB Global FrontLine Risk Program Execution Team. The Global Front Line Risk Program Execution is a function within the CIB COO - Risk Programs pillar. The team has the key focus to maintain, operate and deliver core front line risk and compliance programs and adopt a...
-
Contract Specialist
5 days ago
hyderabad, India Tekgence Inc Full timeJob Title:- CONTRACT SPECIALISTExperience:- 3 Years Location:- HyderabadJob Description:-A Contracts Specialist is a professional who drafts and reviews contractual agreements between companies and suppliers of products or services. Contracts Specialist responsibilities include:Negotiating contract agreements for products and servicesAssessing contractor...
-
Contract Specialist
2 weeks ago
Hyderabad, India Tekgence Inc Full timeJob Title:- CONTRACT SPECIALISTExperience:- 3 Years Location:- HyderabadJob Description:-A Contracts Specialist is a professional who drafts and reviews contractual agreements between companies and suppliers of products or services. Contracts Specialist responsibilities include:Negotiating contract agreements for products and servicesAssessing contractor...
-
Hyderabad, India WELLS FARGO BANK Full timeAbout this role:Wells Fargo is seeking a Business Accountability Specialist to join the CIB Global FrontLine Risk Program Execution Team. The Global Front Line Risk Program Execution is a function within the CIB COO - Risk Programs pillar. The team has the key focus to maintain, operate and deliver core front line risk and compliance programs and adopt a...
-
Hyderabad, India WELLS FARGO BANK Full timeAbout this role:Wells Fargo is seeking a Business Accountability Specialist to join the CIB Global FrontLine Risk Program Execution Team. The Global Front Line Risk Program Execution is a function within the CIB COO - Risk Programs pillar. The team has the key focus to maintain, operate and deliver core front line risk and compliance programs and adopt a...
-
Compliance Specialist
4 weeks ago
Hyderabad, India WELLS FARGO BANK Full timeAbout this role:Wells Fargo is seeking a Compliance Specialist to join the Wells Fargo Advisors Retail Branch Exams Team. The Branch Exams Team is responsible for reviewing compliance with various regulatory and policy requirements by WFA's retail branches and for contributing to the protection of the Firm's clients, employees, and reputation by performing...
-
Quality Complaints Specialist
1 week ago
Hyderabad, India Tek Support Full timePosition Overview :We are seeking an experiencedQuality Complaints Specialistto manage and investigate customer complaints related to medical device products. This role involves ensuring all complaints are handled in compliance with regulatory requirements and company standards, while working closely with cross-functional teams to identify root causes and...
-
Payroll Specialist
2 weeks ago
Hyderabad, India Gamlaa Full timeWe are seeking an experienced Senior Payroll Specialist/Payroll Manager to lead our payroll operations at Gamlaa. The ideal candidate will have at least 18 months of hands-on experience with Keka Payroll, ensuring accurate and timely payroll processing. Responsibilities include managing the full payroll cycle, statutory compliance, employee data, and payroll...
-
Payroll Specialist
5 days ago
hyderabad, India Gamlaa Full timeWe are seeking an experienced Senior Payroll Specialist/Payroll Manager to lead our payroll operations at Gamlaa. The ideal candidate will have at least 18 months of hands-on experience with Keka Payroll, ensuring accurate and timely payroll processing. Responsibilities include managing the full payroll cycle, statutory compliance, employee data, and payroll...
-
hyderabad, India WELLS FARGO BANK Full timeAbout this role:Wells Fargo is seeking a Business Accountability Specialist to join the CIB Global Frontline Risk Program Execution Team. The Global Front Line Risk Program Execution is a function within the CIB COO - Risk Programs pillar. The team has the key focus to maintain, operate and deliver core front line risk and compliance programs and adopt a...
-
hyderabad, India WELLS FARGO BANK Full timeAbout this role: Wells Fargo is seeking a Business Accountability Specialist to join the CIB Global Frontline Risk Program Execution Team. The Global Front Line Risk Program Execution is a function within the CIB COO - Risk Programs pillar. The team has the key focus to maintain, operate and deliver core front line risk and compliance programs and adopt a...
-
Quality Complaints Specialist
1 week ago
Hyderabad, India Tek Support Full timePosition Overview:We are seeking an experienced Quality Complaints Specialist to manage and investigate customer complaints related to medical device products. This role involves ensuring all complaints are handled in compliance with regulatory requirements and company standards, while working closely with cross-functional teams to identify root causes and...
-
Quality Complaints Specialist
1 week ago
Hyderabad, India Tek Support Full timePosition Overview:We are seeking an experienced Quality Complaints Specialist to manage and investigate customer complaints related to medical device products. This role involves ensuring all complaints are handled in compliance with regulatory requirements and company standards, while working closely with cross-functional teams to identify root causes and...
