Clinical Trial Manager

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Who You Are:  

Working for Restore is a unique opportunity, which is why we’re always on the lookout for individuals who stand out from the crowd. Here are some important qualities each team member needs in order to thrive at Restore.

  • Passion matters - It’s our mission to help people feel better, overcome obstacles, and do more of the things they love. Do you share this passion? 
  • Forward-thinking - Our health and wellness services employ a “think outside the box” approach. You’ll get to learn the tech behind what we do as well as the health benefits and potential risks involved. Ready for the challenge?
  • The customer is always comfortable - Each Restore client is part of our wellness community. We need customer service gurus who are inviting, motivated, and eager to educate. Is this you? 
  • Empathy goes a long way - Many of our customers suffer from chronic illnesses, pain, and other debilitating conditions. Lending an empathetic ear and being understanding of their needs is something our team embraces. Wanna make a difference? 
  • A good work/fun balance - Restore is technically a retail environment, but we don’t have a retail vibe. We want our clients to have fun during their visit, which means our team members should have fun too. Sound good?

If you answered yes to these questions, Restore wants to meet you!

KEY ROLES

  • Lead clinical study startup process for Restore’s Healthspan membership, including but not limited to conduct of the study Kick-off meetings, the set-up of trial master file (TMF), and finalization of site and vendor Clinical Trial Agreements and budgets.
  • Lead the Clinical Study Team and proactively manage clinical study level operational aspects with the Team including management of trial timeline, budget, resources and vendors.
  • Work proactively with the Clinical Study Team to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.

Clinical Study initiation and oversight

  • In conjunction with supervisor/mentor, develop, optimize, and implement effective clinical study project plans for each clinical study.
  • Proactively monitor the quality of clinical study deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution, and quality control across the Team.
  • Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
  • Effectively train and provide support to Clinical Sites in the conduct of the trials.
  • Review and approve site visit reports where applicable; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
  • Ensure potential study risks are escalated to the attention of supervisor when the probability of occurrence and expected impact suggest a significant risk to timing, cost or quality of the clinical study and where no effective contingency or mitigation strategy has been developed.
  • Oversee any CROs or vendors to ensure that they are meeting their obligations and conducting work in an appropriate way.
  • Work with all other functions involved in conducting a clinical trial to ensure appropriate clinical operations input is provided (including but not limited to, reviewing eCRFs, user acceptability testing of study related systems, writing and reviewing study related manuals, etc).

QUALITIES

  • Minimum of a bachelors degree in Life Sciences or Nursing Licensure.
  • Prior experience as a clinical project manager, clinical lead or senior CRA is required.
  • Prior monitoring experience is preferred.
  • Relevant therapeutic experience is preferred.

Compensation / Benefits:

  • Competitive salary
  • Insurance Benefits
  • 401k with up to 4% match
  • Flexible Fitness Reimbursement
  • Employee Assistant Program
  • Flexible work schedule
  • Vacation days
  • Access to complimentary and discounted in-store services 


Who We Are: 
Restore Hyper Wellness + Cryotherapy is the leading retail provider of alternative health and wellness modalities in the United States. Our goal is to make Hyper Wellness® widely accessible, affordable, and fun. This means helping people from all walks of life feel better and perform at a higher level so they can do more of what they love in life. Inc. 5000 ranked Restore as the #113 Fastest Growing Company in America, the #17 Fastest Growing Company in Texas, and the #1 Hottest Franchise in America.

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Austin Cryo Ventures LLC d.b.a Restore Hyper Wellness provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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Location

Restore Hyper Wellness' headquarters is located in Penn Field in South Austin off of Congress + Ben White.

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