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Consulting Hot Jobs

Welcome to our customized job portal for our existing and new experts. These roles are hot and fresh opportunities and are updated weekly. You have the first opportunity to view these exciting roles. We want to make this information center a regular part of your career planning as you fill your schedule with new work and look for exciting roles to fulfill your career goals. If you are interested, reply to the post’s contact information, including the job order number and the job title.

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Consulting Hot Jobs Listing Below

Grant Management

 The focus will be on managing budgets and reporting for a DOD grant for malaria drug development.

Our Client has requested one part-time grant management position.  40 hours/month. Role can run up to 3 years.

 

Please contact:

Sherr.Kollath@Advarra.com or ExpertHotJobs@Advarra.com

Clinical Quality Assurance Program Lead – GI/Neuro

Our client is seeking a Clinical Quality Assurance Project Lead to work 20 hours per week to support clinical research studies in GI/Neuro. • Senior level GCP and CQA experience • Extensive senior level audit program management experience to support all aspects of the audit programs. • Review audit plan • Manage and oversee audit plan • Inspection readiness • Ability to support busy audit schedule (many studies) • Support Quality Investigations Requirements • Strong GCP • Strong Quality Issue Management skills • Manage Quality Events/Issues • Support Complex Clinical programs with multiple Clinical Research Studies • CRO and site management• Manage compliance across business functions - quality, clinical, etc

Please contact:

Sherr.Kollath@Advarra.com or ExpertHotJobs@Advarra.com

PK Expert to write protocol

Our client is in need a a PK expert - a PK scientist who can write a protocol for a new chemical entity’s Bioavailability/Bioequivalence study (BA/BE). The study will be run at a CRO. It is a 3-armed study, using two liquid formulations of the small molecule, and one capsule formulation. They are studying Alport syndrome - a very rare disease. They’ve previously done multi-dose PK studies and single dose studies at higher levels, with few signals. They’ll be below the dose that causes headache/nausea, and safety data will not be collected.

If you are interested in this project, Please contact:

Sherr.Kollath@Advarra.com or ExpertHotJobs@Advarra.com

Research Nurse – Chicago, IL

Seeking a Research Nurse to work onsite in Chicago, IL.  Responsibilities include:

 

  • Provides care to patients participating in clinical studies: standard of care procedures, research procedures, study medication administration and adherence assessments, adverse event assessment documentation, blood draw, EKG administration, and various clinical assessments.
  • Implements plan of care in connection with study protocol.
  • Utilizes clinical assessments to ensure patients receive follow-up care as needed.
  • Communicates research-related information to patients, families, nursing, and medical staff, including physicians.
  • Educates the physicians and other clinical staff inpatient and/or outpatient on the study protocol and the plan of care for the research participant.
  • Communicates participant health status changes to PI and clinical care staff.
  • Performs subject assessment, administers medication, and provides nursing support to perform diagnostic, therapeutic, and surgical procedures.
  • Schedules visits: Including providing patient education regarding tests and/or procedures.
  • May enter study-related data into appropriate databases.
  • May collect process and ship potentially biohazardous specimens.

 

BSN, current RN license, and research nursing experience required.  Current training in human subjects protection education, Good Clinical Practice, and HIPAA Privacy. CCRP/CCRC/SOCRA certifications or equivalent preferred. This is a full-time role for three months with the potential extensions.

If  interested, please email monica.bounds@advarra.com or experthotjobs-consulting@advarra.com.

Director Integration & Divestment Regulatory Affairs Contract to Full-time

This role will be a contract role for 6-12 month then move to a full time position. Our client prefers an Expert based in the US, however will consider an EU based as well.

The divestment of non-core assets, optimization of legal entities and acquisition of assets are critical parts of Sponsor's overall business strategy to simplify our portfolio, invest back into our business, and innovate for patients.

The Director/Associate Director Integration and Divestment Regulatory Affairs will lead workstreams, as assigned, considering relevant non-clinical, clinical, labeling, RA-CMC and other regulatory strategies to ensure efficient and compliant execution resulting from an asset transaction. Responsible for comprehensive planning and submitting to regulatory authorities the appropriate documentation to transfer INDs, NDA, BLAs, MAAs, Orphan Drug Designations, PIPs, etc. As part of the R&D Divestment Office. This position reports to the Senior Director, Integration and Divestment Regulatory Affairs and collaborate with regulatory team members including regulatory CROs or contractors and partner with other R&D functions and other Sponsor business units.

o Prior experience supporting acquisitions or divestments strongly preferred

o Direct experience with marketed products outside the US (e.g. Europe and Growth and Emerging Markets) strongly preferred

Please contact:

Sherr.Kollath@Advarra.com or ExpertHotJobs@Advarra.com

Research Nurse (Asheville, NC)

We are in need of a Research Nurse to assist clinical sites with patient care and protocol procedures. Actions may include collecting blood samples, administer vaccines, check lab work, assess patient's health, and review of adverse events.

Onsite position. Start date: 3Q 2022. Duration: 4 weeks, 20 hours a week

If interested, please contact: Sherr.Kollath@Advarra.com or ExpertHotJobs@Advarra.com

Regulatory Coordinator

Our client is seeking a Regulatory Coordinator with a background in Clinical Research and Regulatory Documentation Requirements, FDA Requirements for regulatory document maintenance, etc. The Regulatory Coordinator will assist the Principal Investigator in developing research study-related materials; serve as a support role in communication and accountability for start-up activities; and support site start-up activities and see them through to study activation. This is a part-time, hybrid role that includes remote and onsite support in the Seattle, WA area. If you are interested in this role, please email monica.bounds@advarra.com or reply to experthotjobs-consulting@advarra.com