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Clinical Trial Associate - CA

Location
San Diego, CA

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u003Cpu003EOur client, a leader in the pharmaceutical field, is seeking a Clinical Trial Assistant. u003C/pu003Eu003Cpu003Eu003Cbu003EPrerequisites:u003C/bu003Eu003C/pu003Eu003Culu003Enu003Cliu003ECompleted BA/BS in directly-relevant discipline or equivalent experience requiredu003C/liu003Enu003Cliu003EAt least 2 years experience as CTA (or comparable operating experience) in pharmaceutical or CRO.u003C/liu003Enu003C/ulu003Eu003Cpu003Eu003Cbu003ESummary/Scope: u003C/bu003Eu003C/pu003Eu003Cpu003EThe Clinical Trials Associate (CTA) is involved in the conduct of the study and interfaces with the Study Manager and the Study Team. The CTA also supports the Study Team by creating and distributing study team materials, tools and documents.u003C/pu003Eu003Cpu003Eu003Cbu003EResponsibilities will include, but are not limited to, the following:u003C/bu003Eu003C/pu003Eu003Culu003Enu003Cliu003ESupport the Study Team to select potential investigators and assess their interest in the studyu003C/liu003Enu003Cliu003ECommunicate with the sites through direct contact and other tools such as newsletters as appropriate per study requirementsu003C/liu003Enu003Cliu003ETrack study progress in CTMS including patient enrollment and patient statusu003C/liu003Enu003Cliu003EOversight of Monitoring Visit Report review for CROsu003C/liu003Enu003Cliu003ESupport study data as the EDC administrator and by tracking CRFs and queries as appropriate for insourced studiesu003C/liu003Enu003Cliu003EProcess and track payments to vendors and study sites as appropriateu003C/liu003Enu003Cliu003EQC review of ICFs returned from the sites.u003C/liu003Enu003Cliu003EInvestigational Product reconciliation.u003C/liu003Enu003Cliu003EFinancial Reconciliation at the close of studies Support the Study Manager in creating, updating and tracking MS Project study plans Collecting, quality review and submitting documents to the TMFu003C/liu003Enu003Cliu003EPerforming quarterly QC of TMF as appropriateu003C/liu003Enu003Cliu003ESupport planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendorsu003C/liu003Enu003Cliu003EGenerate, finalize and distribute study team agendas and meeting minutesu003C/liu003Enu003Cliu003EAssist with generating the CSR appendices and participate in SOP and WP development Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiativesu003C/liu003Enu003C/ulu003Eu003Cpu003Eu003Cbu003ESkills/Knowledge Required:u003C/bu003Eu003C/pu003Eu003Culu003Enu003Cliu003ECompleted BA/BS in directly-relevant discipline or equivalent experience requiredu003C/liu003Enu003Cliu003EAt least 2 years experience as CTA (or comparable operating experience) in pharmaceutical or CRO requiredu003C/liu003Enu003Cliu003EComputer skills - MS office suite CTMS (Celtrak)u003C/liu003Enu003Cliu003EKnowledge of databases - preferred - EDC (Medidata), IVRS (Endpoint)u003C/liu003Enu003Cliu003EEfficient at meeting planning / generating minutes Understanding / familiarity with drug development and process and Pharma Strong Verbal and written communications skillsu003C/liu003Enu003Cliu003ESelf starter / proactive Ability to work independentlyu003C/liu003Enu003Cliu003EGood listener / problem solver Ability to prioritize and multi-task and demonstrate flexibility and attention to detailu003C/liu003Enu003Cliu003EFamiliarity with ICH / GCP and regulatory guidelines/directivesu003C/liu003Enu003Cliu003ETeam player and ability to build relationshipsu003C/liu003Enu003Cliu003EStrong organizational skillsu003C/liu003Enu003Cliu003EProficient at Vendor / site payment process Knowledge of medical/scientific terminologyu003C/liu003Enu003Cliu003ECross cultural awarenessu003C/liu003Enu003C/ulu003Eu003Cpu003Eu003Cbu003EKey Competencies:u003C/bu003Eu003C/pu003Eu003Culu003Enu003Cliu003ECommitment to qualityu003C/liu003Enu003Cliu003EWorks efficientlyu003C/liu003Enu003Cliu003EDemonstrate adaptability and flexibilityu003C/liu003Enu003Cliu003EActs with integrity Works independentlyu003C/liu003Enu003Cliu003EShows work commitment Prepares written communicationu003C/liu003Enu003Cliu003EUses technical / functional expertiseu003C/liu003Enu003Cliu003EFosters teamworku003C/liu003Enu003Cliu003EProactive behavioru003C/liu003Enu003Cliu003EListens to othersu003C/liu003Enu003C/ulu003Eu003Cpu003EEEO Employeru003C/pu003Eu003Cpu003EApex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at u003Ca href=mailTo:****\****u003C/au003E or 844-463-6178.u003C/pu003Eu003Cpu003Eu003Cbu003E#LI-NV1u003C/bu003Eu003C/pu003Eu003Cpu003EEEO Employeru003C/pu003Eu003Cpu003EApex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at u003Ca href=mailTo:****\****u003C/au003E or 844-463-6178.u003C/pu003Eu003Cbru003Eu003Cdivu003EVEVRAA Federal Contractoru003C/divu003Eu003Cdivu003EWe request Priority Protected Veteran u0026amp; Disabled Referrals for all of our locations within the state.u003C/divu003Eu003Cdivu003EWe are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available u003Ca href=****target=_blank\u003Ehere.u003C/au003Enu003C/divu003E,datePosted:2018-08-11,employmentType:FULL_TIME,industry:Information Technology,hiringOrganization:{@type:Organization,name:**MEMBERS ONLY**SIGN UP NOW***.},identifier:{@type:PropertyValue,name:**MEMBERS ONLY**SIGN UP NOW***.,value:875821},jobLocation:{@type:Place,address:{@type:PostalAddress,addressCountry:US,streetAddress:,addressLocality:San Diego,addressRegion:CA,postalCode:92101}}}

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