AnneLisa Vallery

Experience

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  Covance

  Jun 2008 - Oct 2011

  Recruited/selected sites for studies; maintained regulatory documents and files in Central and Site Trial Master File; updated, maintained and tracked enrollment status reports to ensure study stays on track to meet enrollment goals; provided study hotline coverage by answering study site questions or escalating questions/issues as applicable to the Study Team; submitted required documents to the Central IRB; created and negotiated new site contracts/budgets; initiated contract/budget amendments as applicable; completed Case Report Form user testing and validation; trained sites on Electronic Data Capture application, CRF review, query review and resolution; adherence to SOPs, FDA regulations, ICH and GCP guidelines. Show less

  • Clinical Research Associate

    Sept 2010 - Oct 2011

  • Clinical Research Assistant

    Jun 2008 - Aug 2010
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  Creative Director

  Jun 2009 - Jun 2010

  Kids4-Change, Inc

  Served one year on the board of the non-profit, Kids4-Change, Inc. My responsibilities included writing letters for funding/sponsorship, creating flyers and social media content.

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  Authentic Living Magazine

  Dec 2011 - Aug 2015

  Executive Editor

  Manage a team of 10 writers; review, edit and proofread all articles to ensure they are ready to be published; create/manage editorial calendar for Facebook, Instagram and Twitter; create content for social media platforms; recruit writers and contributors for the online magazine; create marketing materials and advertisements.

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  PPD

  Dec 2011 - Feb 2015

  Clinical Research Associate
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  InVentiv Health Clinical

  Mar 2015 - Feb 2017

  Senior CRA

  Mentored/trained newly hired CRAs. Assisted clinical operations team as needed including but not limited to all aspects of study site monitoring; CRF review, query generation and resolution; assisted with aspects of site management; escalated discrepancies as needed to management/client as needed; retrained sites where severe non-compliance is identified; update, track, and maintain study-specific trial management tools/systems; generated and tracked drug/device shipments and supplies; attend sponsor calls and internal team calls to stay informed of current study; developed collaborative relationships with investigative sites, client company personnel and study vendors; ensured the protection of study patients; ensured the integrity of study data; adhere to travel and expense reporting policies; prepared accurate and timely reports; adhered to SOPs, FDA regulations, ICH and GCP guidelines. Show less

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  CROMSOURCE

  Mar 2017 - Jun 2023

  Remotely managed project activities in full service clinical studies; performed annual evaluation visits with team members; strategized with Project Director (PD)/Leader (PL) and department heads in resolving performance and resourcing issues; organized and implemented training for remote employees in individual stages, group seminars, and via department newsletters; strengthened talent retention and employee development procedures; strategized with department head to identify team training opportunities; developed and revised SOPs or processes; regulated approvals for team expenses and time allocations; managed the budget of a project; supervised the workload and performance of the project team; ogranized the tasks of the team in specific areas; orchestrated CRA activities ensuring compliance with SOPs, FDA regulations, ICH and GCP guidelines; delivered project specific trainings; organized and provided project updates to the client and PD/PL. Show less

  • Regional CRA Manager

    Jun 2018 - Jun 2023

  • Lead Clinical Research Associate

    Mar 2017 - May 2018
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  Causing Legacy Inc

  May 2021 - now

  President

  Cause effective leadership such that organization’s mission is fulfilled which includes building and growing teams; recruiting and organizing volunteers; managing the distribution of donations; leading/facilitating workshops with BIPOC teens and youth.

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  Cosmic Mothering LLC

  Mar 2023 - now

  Doula | Healer | Coach

  We help families welcome and care for their babies earthside through education and loving support from conception through postpartum, so families can have peace and harmony throughout their birthing journey.