Senior Regulatory Specialist

4 weeks ago

pune, India Lifelancer Full time

About thejob:

Summary:

TheSenior Regulatory Specialist is the subject matter expert andleader of a regulatory team to prepare and maintain complete andaccurate regulatory documents in support of clinical researchstudies.

RoleResponsibilities:

  • Leads a team of multiple regulatory specialists supporting one ormore Clinical Research sites
  • Ensuresregulatory submissions are done in a timely manner as to not delaystudy start up.
  • Prepare each study specificprotocol informed consent form HIPAA authorization and otherrelated documents for review by the IRB.
  • Prepare and submit amendments yearly requests for continuingapproval of open protocols audits adverse event reports and anyother IRBrequired submissions.
  • Work with staffmembers to complete conflict of interest paperwork for eachstudy.
  • Assist new hires in completing andsubmitting all required research documentation andtrainings.
  • Track training status for existingstaff assisting with updates as needed.
  • Maintain study binder with all IRB related documents andcorrespondence for each study.
  • Maintainelectronic regulatory files including tracking documenthistory.
  • Maintain a database of staff listingsand training dates.
  • Proactively notify staffand Site Manager/Director of upcoming training expiration dates tomaintain compliance
  • Coordinate meetings withauditors to review paper and electronic regulatory files andinspectors.
  • Provide copies of IRB documents tosponsors as needed.
  • Adhere to safety andcompliance regulations.
  • Stay abreast ofevolving regulatory trends and work with the Site Manager/SiteDirector to ensure compliance with changes in theregulations
  • Ensures binder accuracycompleteness and inspection readiness
  • Preparelocal IRB submissions
  • Review ICFs forcompleteness ensure the California Bill of Rights is included asapplicable subject stipends are accurate and all protocolprocedures are captured in the ICF
  • Ensuresthat ICFs and other study documents are available in any languageas required by the site and approved by theIRB
  • Works with the IRB of record to submitgeneric site material
  • Other duties asassigned

Education/Experience:

  • Bachelors degree and 4 years of clinical research regulatoryexperience OR
  • Associates degree with 6 yearsof clinical research regulatory experience OR
  • High School Graduate and/or technical degree with minimum of 8years of clinical research regulatoryexperience

RequiredLicenses/Certifications:

None

Certified Clinical Research Professional aplus

RequiredSkills:

  • Proficient inthe use of the following technology: Computers Microsoft Officesoftware fax copier and multiline telephone.
  • Proficient ability to work in a fast pacedenvironment
  • Advanced verbal written andorganizational skills
  • Advanced interpersonaland communication skills
  • Advanced ability towork as a team player
  • Advanced ability to readwrite and speak English
  • Demonstrated abilityto multitask
  • Demonstrated ability to mentorand train
  • Advanced ability to follow writtenguidelines
  • Proficient ability to workindependently plan and prioritize with minimalguidance
  • Proficient ability to beflexible/adapt according to the needs of the clinicpriortization
  • Must be detailed oriented andcan demonstrate attention to detail
  • Proficientproblem solving and strategic decision makingability.
  • Advanced in accepting individualresponsibility for actions taken and demonstrating professionalismwhen judged critiqued and/or praised
  • Proficient leader mentor an team builder
  • Advanced understanding of ICH GCP and FDA regulatoryrequirements

Please usethe below link for job application and quickerresponse.


RemoteWork :

No

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