ClinicalOperationsLead

Essential?Functions:
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1.?Communication?-?Keeps?project?leadership?apprised?of?team?issues,?seeking?guidance?as?needed.?Maintains?timely?and?effective?communication?among?team?members?and?site?staff.?Attends?Kick-Off,?Quick?Start,?and?Investigator?meetings.
2.?Regulatory?Documentation?-?Independently?resolves?protocol?questions?with?the?Project?Manager?(PM)?and?patient?related?issues?with?the?Medical?Monitor?(MM).?Maintains?a?record?of?all?contacts?with?the?PM?or?MM?concerning?protocol?deviations?and?clarifications.
3.?Monitoring?-?Develops?clinical?plans?and?guidelines,?including?clinical?monitoring?plans.?Assures?compliance?with?monitoring?intervals?according?to?the?project?requirements.?Typically?acts?as?LCRA?on?studies.
4.?Monitoring?and?Oversight?-?Reviews?the?study?scope?of?work,?budget,?and?protocol?content.?Provides?training?to?project?teams?on?protocol,?Case?Report?Form?(CRF)?completion,?Sponsor?Standard?Operating?Procedures?(SOPs),?clinical?plans?and?guidelines,?and?timelines?for?the?study.
5.?Business?Development?-?Prepares?and?presents?materials?for?bid?defense?meetings.
6.?Administrative?-?Provides?status?reports?to?the?PM?and?the?Sponsor?on-site?initiation,?enrollment,?visit(s)?scheduled,?and?trip?report?completion.
7.?Line?Manager?–?May?be?responsible?for?the?supervision?and?administrative?oversight?of?direct?reports,?which?are?most?commonly?CRAs.?Develops?training?plan?and?assures?training?compliance?for?all?direct?reports.?Evaluates?strengths/developmental?opportunities?of?staff?members.?Sets?clear?goals?and?objectives?for?all?direct?reports.?Completes?performance?reviews?and?implements?performance?plans.?
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Requirements:
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BA/BS?degree?in?the?science/health?care?field?or?nursing?degree,?or?equivalent?combined?education?and?experience.?Moderate?independent?field?monitoring?experience.?Minimal?lead?monitoring?or?comparable?supervisory?experience.?Extensive?understanding?of?SOPs,?Work?Instructions?(WI),?FDA,?and?local?regulations?as?well?as?ICH?GCP?guidelines,?and?an?advanced?understanding?and?application?of?applicable?therapeutic?standards.?Strong?organizational,?documentation,?and?interpersonal?skills?as?well?as?a?willingness?to?work?within?a?team-oriented?environment.?Proficiency?in?Microsoft?Office?Suite?(Word,?Excel,?and?PowerPoint),?e-mail,?and?voicemail.?Effective?command?of?written?and?spoken?local?language,?if?not?English,?as?well?as?English.?Ability?to?handle?multiple?tasks?to?meet?deadlines?in?a?dynamic?environment.?Must?have?valid,?current?driver's?license?and?ability?to?secure?corporate?credit?card.?ACRP?CCRA?or?equivalent?certification/credentials?strongly?preferred.