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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

Clinical Research Nurse – Chicago, IL

Our Client is seeking a Clinical Research Nurse to work onsite/remote in Chicago, IL.  The Clinical Research Nurse responsibilities include the following:

 

  • Provides nursing care to patients participating in clinical research studies, may include: 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 nursing 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, as necessary.
  • 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 and ensures study related orders are completed for the visit. 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, hybrid (onsite and remote) for six months with the potential extensions. If you are interested in this role, please email monica.bounds@advarra.com.

 

GLP Lab to Compliance Consultant

Advarra is seeking a consultant for a remote, part-time opportunity to lead a team to set up a 1200 sq/ft lab space become GLP and FDA compliant. If you are interested in this role, please elaborate on your related experience and email Alexandrea.Marino@advarra.com or experthotjobs-consulting@advarra.com.

Data Integration/Transfer of Data from a Device

Seeking an Expert in data integration including digital data from devices, preferably pathology systems. This is a remediation of data coming in through imagines of slides. Looking for an candidate with expertise in validation of systems, data integration, and transfer of data from a device. The client is concerned about the data and this effort would be to take a deep dive into the database.

All work is remote.

If you are interested in this role, please reach out to:

Product Director, Neuroscience Digital Marketing 

Our client is seeking a Product Director, Neuroscience Digital Marketing that will be responsible for the following:

  • Identifying innovative digital vehicles and work closely with brands to create strategically aligned, compelling, timely and personalized content for Neuroscience patients and caregivers.
  • Stay informed of the emerging internal digital enablement infrastructure to help the brands they support leverage those capabilities to best support brand objectives.
  • Working closely with the Franchise Digital Group Product Director and brand teams, along with IT, digital and professional agencies and vendors, to deliver standard methodologies and ensure executional excellence, KPI delivery and superior customer engagements across all digital engagements.

This is a full-time, hybrid opportunity with onsite 3 days per week in the Titusville, NJ area. This is a one year opportunity.  There is not a consistent travel requirement, only some occasional ad hoc travel. If you are interested in this role, please email monica.bounds@advarra.com or experthotjobs-consulting@advarra.com.

Product Director, Franchise Operations 

Our client is seeking a Product Director Franchise Operations that will be responsible for franchise strategy execution and pull through across all neuroscience brands. The Product Director Franchise Operations will be responsible for the following:

  • Understand and gain deep customer insights for all critical stakeholders within key accounts across the neuroscience healthcare ecosystem (Federal accounts, IDNs, inpatient/outpatient care delivery accounts, trade accounts incl. pharmacy and payers accounts)
  • Support development of clear and prioritized end to end business plans and own KPI dashboards and metrics to track impact and outcomes
  • Directly partner with national director of key accounts, franchise strategy and field selling organizations to ensure flawless field execution of account strategies and initiatives
  • Closely partner with diverse internal stakeholders to ensure communication and planned activities within accounts are coordinated and drive synergistic outcomes
  • Support promotional material development including copy approval
  • Support brand teams with congress planning and execution

This is a full-time, hybrid opportunity with onsite 3 days per week in the Titusville, NJ area. The duration of this project is one year. If you are interested in this role, please email monica.bounds@advarra.com or experthotjobs-consulting@advarra.com.

GCP TRAINING GUIDE DEVELOPMENT - MHRA INSPECTOR (Worked for MHRA)

A large sponsor is asking Advarra to develop a training guide specific to GCP Inspections for MHRA. This guide will provide training and internal mock interviews to prepare for inspections. A general guide for how the inspectorate Health Authority goes about the inspection, key areas of focus for each functional area, insights and tips, plus a detailed list of questions that are typical for each type of inspectorate. In addition to the initial development of the guide, regular updates will need to be made in order for the guide to remain current.

If you are interested in this role, please reach out to:

GCP TRAINING GUIDE DEVELOPMENT - EMA INSPECTOR ( Worked for EMA)

A large sponsor is asking Advarra to develop a training guide specific to GCP Inspections for EMA. This guide will provide training and internal mock interviews to prepare for inspections. A general guide for how the inspectorate Health Authority goes about the inspection, key areas of focus for each functional area, insights and tips, plus a detailed list of questions that are typical for each type of inspectorate. In addition to the initial development of the guide, regular updates will need to be made in order for the guide to remain current.

If you are interested in this role, please reach out to:

GCP TRAINING GUIDE DEVELOPMENT - FDA INSPECTOR (Worked for the FDA)

A large sponsor is asking Advarra to develop a training guide specific to GCP Inspections for FDA. This guide will provide training and internal mock interviews to prepare for inspections. A general guide for how the inspectorate Health Authority goes about the inspection, key areas of focus for each functional area, insights and tips, plus a detailed list of questions that are typical for each type of inspectorate. In addition to the initial development of the guide, regular updates will need to be made in order for the guide to remain current.

If you are interested in this role, please reach out to:

System Validation Expert

 

One of Advarra's clients is seeking a System Validation Expert. The manufacturing system validation expert will assess the process, tooling, device manufacturing and technology for a drug/device combination product. Expertise in process engineering and familiarity with validating multiple systems, processes, 3rd party vendor collaboration, artificial intelligence/machine learning and microchip technology. The Expert does not need to have deep expertise in all areas of validation, but should be familiar with all elements needed to validate a complex commercialization of a drug/device combo product.  This is a full-time remote role for 6 months.

If you are interested in this role, please email monica.bounds@advarra.com or experthotjobs-consulting@advarra.com.

Clinical Research Coordinator

Our client is seeking a Clinical Research Coordinator with 5+ years of Clinical Research/Study Coordinator experience.  The Clinical Research Coordinator should have experience taking medical and concomitant medication history, receiving and escalating AEs/SAEs, experience in patient education/training. Registered Nurse experience is highly preferable. Technology guru with ability to troubleshoot devices, work with Microsoft Office programs, CRM.

This is a full-time, remote role but must be available to work 8 a.m. – 8 p.m. Pacific Standard Time.  If you are interested in this role, please email monica.bounds@advarra.com or experthotjobs-consulting@advarra.com.

SOP Gap Review and Fit for Purpose Quality System Consultant

 

Job Description:

Advarra is seeking a consultant for a remote SOP Gap Review & Fit for Purpose Quality System for approximately 3-6 months to help write SOPs (GCP/GMP), perform a mini SOP Gap Analysis, and manage Quality deliverable for fit for purpose system that will mesh into a larger QMS budget.

If you are interested in this role, please email Alexandrea.Marino@advarra.com or experthotjobs-consulting@advarra.com.

HA Experience- FDA, EMA, MHRA

We are putting together a list of Experts who have direct experience working for one of the Health Authorities listed above.  We are getting more requests from clients with this direct experience and would like to have a working list of these Experts to quickly provide to our clients.

If you have this expertise, please reach out to:

Clinical Trial Manager

This is a small Biotech in the Boston area specializing in ophthalmologic cancers. They are in need of a FT CTM who can hit the ground running. They are looking for a mid-level CTM with oncology and/or ophthalmology experience.

They will start with a 6 month FT remote contract with a high probability of an extension.

 

If you are interested in this role, please reach out to:

QUALITY ASSURANCE BIOMARKER - BIOLOGICS

Senior level Quality Assurance Biomarker consultant with experience in Cell & Gene Therapy (Biologics)

Remote

10-20 hours per week for a minimum of 6 mths

Description

A large sponsor is seeking a Quality Assurance Biomarker Expert for Cell & Gene Therapy. Working with a variety of disease indications. This Expert will: - validate analytical process - Control management for all know resources (preanalytical and analytical variations) - Certify materials and quality control instruments/tools program i.e., quality manual, internal/external quality controls - QA measurements to be used for assessing accuracy of routine methods - Grading of biomarkers - Evaluating and grading laboratories for test significance and work level This work is part time approximately 10-20 hours per week for a minimum of 6 months

If you are interested in this role, please reach out to:

Director Clinical Development - Oncology

This position is in the clinical development and operations function.  The role will be hybrid, both working remote and at our client's R&D site in San Diego, CA.  It is a 6 month contract working part-time.

  • Solid training and/or broad experiences in oncology clinical development is required
  • The candidate will work with project teams to advance novel preclinical lead molecules into the clinic and will provide scientific guidance and support in all aspects of the clinical program such as study design, development, execution, data readout, and summary
  • This candidate will also be a resource to teams for guidance of all matters related to analysis and communication of clinical data.
  • In addition, the candidate is expected to be skillful in integrating information from various functions and be articulate in communicating company clinical development strategy to internal and external stakeholders.

Qualifications:

  1. Medical Degree (MD or DO) preferably board certified in medical oncology.
  2. 10+ years’ experience in clinical development with at least 5 years in the biopharmaceutical industry. Experience in translational medicine/early phase oncology clinical trials is a plus.
  3. Solid understanding of GCP/ICH/IRB and local regulatory authority drug research and development guidelines and regulations

 

If you are interested in this role, please reach out to:

Clinical Research Associate with Travel

Our Client has received two IND clearances from the FDA this year and are in need of adding a CRA, This role will complete all aspects of site monitoring for clinical research studies according to Standard Operating Procedures (SOPs) and ICH/GCP/GLP guidelines. Will start part time with 2 sites and will move to 4 sites.  This could be one full time person or 2 part-time candidates.

Qualifications:

  • Bachelor’s Degree (BA/BS) in life sciences or nursing degree
  • Minimum of five (5) or more years of relevant experience in clinical research or healthcare related industry or equivalent combination of education and experience
  • Independent site monitoring experience in all phases of clinical trials (phase 1, 2, and 3)
  • Experience in oncology is highly preferred
  • Experience/training in the following areas: GCP Regulations, ICH Guidelines, Good Quality Practices, 21CFR, HIPAA, Drug Development and Approval Process Proficiency with MS Office Excellent oral and written communication skills including presentation skills
  • Ability and willingness to travel to investigational sites for on-site monitoring visits-Houston, Boston and Charlotte, NC.
  • Ability to perform virtual monitoring remotely as needed

If you are interested in this role, please reach out to:

Hematology Research Physician Scientist

Advarra is seeking a consultant for a remote, part-time Senior Hematology Physician Scientist for an early phase program to partner with current PHD program lead with RNAi technology approach. If you are interested in this role, please email Alexandrea.Marino@advarra.com or experthotjobs-consulting@advarra.com.

Cell and Gene Therapy Projects

Advarra is experiencing more and more work every day in the Gene and Cell space.  As we move into the future with this product offering we are building a strong bench of Experts to support this work.  We are seeing these projects span across all of our Centers of Excellence (Regulatory, Clinical, Quality, and Institutional Research).  If you have experience in the Gene and Cell  area and would like to be considered for these projects, please reach out via email and ensure we have an updated resume showing this experience.

Please contact:

Sherr.Kollath@Advarra.com