Clinical Trial Coordinator II

4 months ago

Mumbai, India Lifelancer Full time

About thejob

WorkSchedule

Standard(MonFri)

EnvironmentalConditions

Office

Summarized Purpose:

Provides administrative and technical support to theProject Team. Supports audit readiness by ensuring files arereviewed according to the schedule detailed in the organizationsSOP and department guidance document. Provides administrativesupport for site activation activities. Aids the development of thecritical path for site activation within assigned projects insupport of rapid site activations. Represents CRG personnel. Mayutilize local knowledge organization systems external site listsand sponsor directives to develop and review site lists that aresuitable for the strategic needs of feasibility activities and toprovide local input into the site tiering process. May act as abuddy during onboarding phase and provide training to new staff asneeded.

EssentialFunctions

  • Accordingto the specific role (Central or Local) coordinates oversees andcompletes functions on assigned trial(s) activities as detailed onthe task matrix.
  • Performs department InternalCountry and Investigator file reviews as assigned and documentsfindings in appropriate system(s).
  • Ensuresallocated tasks are performed on time within budget and to ahigh1quality standard. Proactively communicates any risks toproject leads.
  • Provides system support (i.e.Activate eTMF) and ensures system databases are alwayscurrent.
  • Performs administrative tasks onassigned trials including but not limited to timely processing ofdocuments sent to Client (e)TMF as assigned performing (e)TMFreviews distributing mass mailings and communications as neededproviding documents and reports to internal teammembers.
  • Analyzes and reconciles study metricsand findings reports. Assists with clarification and resolution offindings related to site documentation.
  • Assists with coordination compilation and distribution ofInvestigator Site File (ISF) and Pharmacy binder materials andnonclinical study supplies to sites.
  • Assistswith studyspecific translation materials and translation QC uponrequest.
  • Maintains knowledge of andunderstands SOPs client SOPs/directives and current regulatoryguidelines as applicable to services provided.
  • Where applicable conducts onsite feasibility visits (Asia Paconly).
  • May support scheduling of client and/orinternal meetings.
  • May review and track oflocal regulatory documents.
  • May provide systemsupport (i.e. Activate eTMF). May support RBMactivities.
  • May support the maintenance ofstudy specific documentation and systems including but not limitedto study team lists tracking of project specific trainingrequirements system access management and tracking of project levelactivity plans in appropriate system(s).
  • Transmits documents to client and centralizedIRB/IEC.
  • Maintains vendortrackers.
  • Supports startup team in Regulatorysubmissions.
  • Works directly with sites toobtain documents related to site selection.
  • Assists the project team with the preparation of regulatorycompliance review packages.
  • Provides supportas needed to coordinate with internal departments ensuring sitestarttup activities within the site activation critical path arealigned.
  • May complete the Site Interest Planin CTMS and collection and delivery of associated documents frominvestigators and site personnel.
  • Documents inreal time all communication attempts an follow up associated withsite contact and survey responses.
  • Supportsthe review of survey data to ensure responses are logical completeand reflective of the question asked.
  • Works incollaboration with teammates to achieve targeted deadlines forassigned projects. Communicate with the team and appropriateclinical personnel regarding site issues andrisks.
  • Ensures an efficient effective plan isin place for site contact and follow up. Ensure compliance with theplan and escalate concerns/noncompliance tomanagement.
  • May act as the local expertregarding site capacity and experience. Work with key localpersonnel to gather knowledge base and recommend additional sites.Harness this knowledge base when performing local tiering ofsites.
  • Liaises with Global InvestigatorServices to resolve investigator queries in real time and maintainaccounts and contact information.
  • Contributesto the development and rollout of global strategic feasibilityprocesses and best practices.
  • Trains newpersonnel in processes and systems.
  • Utilizeslocal knowledge to contribute to the identification and developmentof new sites.

Knowledge Skills andAbilities:

  • BachelorsDegree in Life Science is preferred
  • Shouldhave 25 years of experience in CRC or CTC role
  • Should have excellent Business communicationskills
  • Should have good knowledge on eTMF andICH GCP related activities
  • Should be able tojoin us immediately
  • Preferably from Mumbai andnear by locations
  • Ability to work in a team orindependently as required
  • Good organizationalskills and strong attention to detail with proven ability to handlemultiple tasks efficiently and effectively
  • Demonstrated ability to effectively analyze projectspecificdata/systems to ensure accuracy and efficiency
  • Strong customer focus
  • Flexibility toreprioritize workload to meet changing projecttimelines
  • Demonstrated ability to attain andmaintain a good working knowledge of applicable Country RegulationsICH Good Clinical Practices and organization/Client SOPs and WPDsfor all non1clinical/clinical aspects of project implementationexecution and closeout
  • Good English languageand grammar skills and proficient local language skills asneeded
  • Good computer skills proficient in MSOffice (Word Excel and PowerPoint) and ability to obtain knowledgeand master all clinical trial database systems
  • Ability to successfully complete the organizations clinicaltraining program
  • Selfmotivated positiveattitude and good interpersonal skills
  • Effective oral and written communicationskills
  • Good interpersonalskills
  • Essential judgment and decisionmakingskills
  • Capable of accurately following projectwork instructions
  • Good negotiationskills
  • Independentthinker
  • Ability to manage risk and performrisk escalationappropriately

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/bcdda2852d5f8b63b9e7e6f29bf1127f

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