The LifeNet Health mission is simple: Saving Lives. Restoring Health. Giving Hope. Its mission, along with its core values of safety, quality, innovation and service continue to create an unmatched record in transplant solutions, which cannot be achieved without talented, dedicated team members who share the same values and attributes that guide the LifeNet Health team every day.
If you have a commitment to customer care, quality and innovation as well as integrity and passion, then you've come to the right place.
We are currently seeking a Clinical Research Associate to join the LifeNet Health team in our Virginia Beach, VA location.
As a Clinical Research Associate, you would be 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 up to 50% travel.
You would be expected to perform all tasks assigned to you, including but not limited to:
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.
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.
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.
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.
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.
Bachelor's Degree in Biological Science or Nursing;
CCRP/ CCRA Certified Clinical Research Professional/ Associate. (Must obtain certification within 1 year of hire date.)
Five (5) Years' Experience Healthcare, Pharma or Biotech industry in clinical trial monitoring, manuscript development and/or investigator-initiated research project management
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
Good Clinical Practice (ICH E6 rev 2- GCP) - Demonstrated in-depth understanding of regulations pertinent to clinical research and experience in clinical monitoring functions
Good Manufacturing Practices (cGMP) - Strong experience/ knowledge of medical device manufacturing regulations
Communication and technical writing - Excellent verbal and written skills. Able to create and revise documents, presentations and training materials according to established requirements
Microsoft Office Applications - Strong computer proficiency in MS Word, Excel, and PowerPoint
Monitoring and Auditing - Demonstrated in-depth understanding of all regulations pertinent to clinical research and auditing concepts
Analytical Thinking - Able to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends
Industry regulations, standards and guidelines - Able to review requirements, determine relevance to processes within the organization, and ensure compliance as applicable
Problem resolution - Demonstrated ability to anticipate and critically think through problems
Master's Degree Biological Science or Nursing
Three (3) Years' Experience Clinical Trials Management
Get to Know LifeNet Health:
LifeNet Health, headquartered in Virginia Beach, Virginia, is the largest nonprofit organ procurement organization (“OPO”) and tissue bank in the United States, as well as a leading innovator in transplantation research and regenerative medicine. LifeNet holds the longest running current accreditation by the American Association of Tissue Banks (AATB). Its goal is to improve the quality of human life through the provision of organs and tissues for transplantation, as well as innovation in the fields of bio-implants and regenerative medicine, and to serve the community with educational and support services that enhance the donation process.
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.