Clinical Research Associate Jobs

Description

Clinical Research Associate

Location: Various

Department: Global Regulatory and Clinical Affairs

Job Type: Full-Time

Shift: Monday-Friday 8:15 AM - 5PM; Other times as assigned/ up to 50% travel with overnight stays

LifeNet Health is searching for talented individuals who will embrace our mission of saving lives, restoring health, and giving hope.

LifeNet Health, headquartered in Virginia Beach, Virginia, is the largest nonprofit organ procurement organization (“OPO”) and tissue processor in the United States, as well as a leading innovator in tissue engineering and regenerative medicine. Our goal is to improve the quality of human life through the provision of organs, tissues and cells for transplantation; to provide innovation in the fields of bio-implants, regenerative medicine and research; and, to serve the community with educational and support services that enhance the donation process. LifeNet Health has over 1200 employees and has a growing global presence.

How You Will Contribute To LifeNet Health’s Success

The Clinical Research Associate is responsible for managing assigned clinical research trials and ensuring the trials are on schedule and in compliance with all regulatory requirements. This position develops and executes clinical studies including the preparation of informed consent forms, investigational plans, and study materials (e.g., training materials, case report forms, study files, supply requirements) while ensuring that research is conducted in accordance with FDA regulations, GCPs, ICH guidelines, International regulations and internal SOPs. This position supports the overall business operations, utilizing an analytical approach to product efficacy and safety, by ensuring clinical sites are performing in accordance with internal SOPs, clinical trial agreements, and required government regulations. Responsible for ongoing site monitoring activities from study initiation to close-out, data management and reporting of results. Requires an average of 50% travel.

What You’ll Do

• Protocol Development: Designs study related documents according to the study requirements, during the protocol development process. Leads the CMS clinical trial approval submission process for assigned trials.
• Customer Service: Liaison between clinical sites and LifeNet Health internal teams (e.g. Scientific Affairs, Marketing, R&D, Contracts Admin/ Legal) regarding assigned study management.
• Regulatory Compliance: : Performs Institutional Review Board (IRB) submission efforts related to LifeNet Health research and development team determinations. Supports Regulatory Affairs with regulatory agency submissions for new product development by providing clinical trial data review, synopses and reports for those submissions. Posts and manages disclosure of active clinical studies on clinicaltrials.gov.
• Clinical Trial Management: Manages assigned clinical trials from site start-up to the close-out visit. Monitors and audits clinical sites/ Investigators to ensure that clinical evaluations are conducted in accordance with FDA regulations, GCPs, ICH guidelines, International regulations and internal SOPs. Conducts clinical study visits (site initiation and training, interim monitoring and close-out). Collects and tracks investigator/ site binder documents and Trial Master Files. Implements strategies for subject enrollment to ensure timely completion of study, in alignment with department and LifeNet Health strategic objectives. Trains Physician investigators and site staff to report adverse events, protocol deviations and technical observations. Finds and decides how adverse events and protocol deviations effect study data and establishes corrective action plans to minimize risk to research subjects. Develops monitoring plans and ensures all mandated activities are completed according to this plan. Develops, maintains and analyzes quality metrics for Clinical Affairs related activities.
• Data Management: Coordinates internal and external resources to define the statistical plan that drives study design. Summarizes and condenses clinical evaluation results into publishable content and format in conjunction with clinical investigators. Provides study summaries for management that includes reports, graphs and tables, as requested.

What You’ll Bring (Minimum Requirements)

• Valid State Driver’s License
• Bachelor’s Degree in Biological Science or Nursing required; Master’s Degree preferred
• Certified Clinical Research Professional/Associate (CCRP/CCRA) preferred or must be able to obtain within 1 year of hire date.
• Five (5) years experience in Pharma or Medical Device industry in clinical trial monitoring, manuscript development and/or investigator-initiated research project management experience.
• Three (3) years Clinical Trials Management experience preferred.

These Would Be Nice Too (Knowledge Skills And Abilities)

• Microsoft Office Applications: Strong computer proficiency in MS Word, Excel, and PowerPoint
• Industry regulations, standard and guidelines: Able to review requirements, determine relevance to processes within the organization, and ensure compliance as applicable
• Communication and technical writing: Excellent verbal and written skills. Able to create and revise documents, presentations and training materials according to established requirements
• Good Manufacturing Practices (cGMP): Strong experience/ knowledge of medical device manufacturing regulations
• Good Clinical Practice (ICH E6 rev 2- GCP): Demonstrated in-depth understanding of regulations pertinent to clinical research and experience in clinical monitoring functions
• Analytical Thinking: Able to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends
• Working Knowledge of FDA/ICH Regulations: Maintain compliance with FDA/ ICH regulations and guidance related to product development, approval/ clearance pathways, submission and clinical trial execution

Why work at LifeNet Health?

We have a fierce drive for our mission of Saving Lives, Restoring Health, and Giving Hope. You won’t find another company with a culture as strong as ours.

• 403(b) and Profit-Sharing Plan
• Tuition reimbursement
• Affordable medical, dental, and vision coverage
• Wellness Program (gym reimbursement, monthly wellness webinars, mental health toolkit, financial resources, and much more)
• Employee Assistance Program (EAP) for employees and members of their household
• Personal career, skill, and leadership development opportunities
• Work-life balance with generous paid time off to include vacation time, sick time, and paid holidays
• Dedicated and passionate co-workers
• Corporate sponsored events for employees

We are proud to be an EEO/AA employer EOE/M/F/Disability/Vet. We maintain a drug-free workplace and perform pre-employment substance abuse testing.