Precision for Medicine
Healthcare
Senior/ClinicalResearchAssociate
“Senior/Clinical Research Associate at Precision for Medicine. Skills: Clinical research, Study site management, ICH-GCP. Provide overall support to study sites. Support clinical project teams”
What You'll Achieve.
Consistently low query levels; Acceptable Quality Assurance reports
Industry & Context.
Critical thinking; Independent judgment; Problem resolution
60-70% travel
What They're Looking For.
Must Have
Bachelor's degree or equivalent, Minimum 2 years on-site monitoring, Fluency in English communication
Nice to Have
1 year oncology experience, Solid experience in clinical research, Ability to work efficiently remotely
What You'll Do.
Provide overall support to study sites
Support clinical project teams
Adhere to applicable protocols
Adhere to regulatory requirements
Act as point of contact for study sites
Execute core responsibilities consistently
Work independently as study team member
Oversee study site management aspects
Ensure patient safety is protected
Ensure quality of data generated
Provide guidance towards audit readiness
Support preparation for audit
Support required follow-up actions
Update study specific trial management tools
Track study specific trial management tools
Maintain study specific trial management tools
Update status reports
Maintain status reports
Manage site start up procedures
Recruit potential investigators
Prepare EC/IRB submissions
Collect regulatory documents
Review regulatory documents
Review Patient Informed Consents
Adapt Patient Informed Consents
Notify regulatory authorities
Translate study related documentation
Assist negotiation of study budgets
Execute investigator contracts
Verify informed consent process
Assess factors affecting subject safety
Assess factors affecting data integrity
Conduct pre-study visits
Conduct qualification visits
Conduct initiation visits
Conduct routine monitoring visits
Conduct close-out visits
Prepare monitoring reports
Submit monitoring reports
Document activities via confirmation letters
Document activities via follow-up letters
Document activities via trip reports
Document activities via communication logs
Document activities via project documents
Support subject recruitment strategies
Support subject retention strategies
Support subject awareness strategies
Enter data into tracking systems
Track all observations
Track assigned action items
Resolve assigned action items
Review Investigator Site File
Reconcile Investigator Site File
Reconcile Trial Master File
Ensure investigator site is aware of archiving requirements
Communicate protocol/study issues
Communicate deviations
Implement necessary actions
Develop working relationship with investigators
Develop working relationship with study staff
Serve as ambassador for Precision
Perform investigational product inventory
Perform investigational product reconciliation
Review investigational product storage
Review investigational product security
Verify IP dispensed to subjects
Verify IP administered to subjects
Verify issues associated with blinded information
Verify risks associated with blinded information
Verify issues associated with randomized information
Verify risks associated with randomized information
Apply knowledge to ensure IP labelled
Apply knowledge to ensure IP imported
Apply knowledge to ensure IP released
Apply knowledge to ensure IP returned
Perform data review activities
Review remote EDC CRF
Review patient profiles
Assist data management personnel
Assist clinical data quality personnel
Resolve data discrepancies
Identify Serious Adverse Events
Process Serious Adverse Events
Suggest contingencies for risks
Own resolution of risks
Prepare for Investigator Meetings
Attend Investigator Meetings
Attend sponsor face-to-face meetings
Participate in global clinical monitoring meetings
Participate in project staff meetings
Attend clinical training sessions
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Study sites; Clinical project teams; Site personnel; Precision Project Management; Clinical Trial Management; Site personnel; Project team
Communication Scope
English communication; Verbal communication; Written communication; Presentation skills
Process & Methodology
Clinical Trial Management, Project Management
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