Clinical Research Associate, Device (Contract, Home-Based) - NCR

Clinical Research Associateprofessional with a proven track record of clinical study execution andmanagement. The successful candidate will be expected to

1)Lead the execution ofa portfolio of studies,

2)Perform monitoring atall clinical study sites

3)Manage relationshipwith vendors including CROs, monitors, laboratories and bio-statisticians

4)Refine and manage thecompany’s clinical processes and procedures, and

5)Manage clinical sites

Key responsibilities:

  • Manage externalclinical studies involving non-significant risk (NSR) class II medical devicesand products. Studies include proof of concept/pilot studies, optimizationstudies, clinical and usability studies, marketing studies and studies directedtowards FDA submissions
  • Perform and overseeremote monitoring duties (from site qualification and initiation through siteclosure) – Work closely with site personnel, other department members andcontactors to ensure protocol, procedure, and regulatory compliance – Monitorcase report forms, study logs, and data (including quality of photography andother scientific measurements), identify and resolve discrepancies, recommendcorrective and preventative action in a timely manner
  • Communicate and workwith Clinical Site Coordinators, Data Management Organizations, InstitutionalReview Boards (IRBs), and Clinical Research Organizations (CROs)
  • Develop, prepare andwrite protocols, informed consent forms, photograph release forms, marketingtestimonial release forms, subject questionnaires, case reports forms, sourcedocuments, instruction materials, and various study logs.
  • Correspond with IRBincluding prepare and submit initial submissions, amendments, and requiredreports
  • Assist with FDA andOUS regulatory submissions, amendments, and required reports to the FDA. Assistin responses to requests for additional information during regulatory review
  • Manage budgetincluding contract development with clinical trial sites, principalinvestigators, CROs, data management organizations and clinical researchconsultants
  • Prepare trainingmaterials for study personnel, contractors and internal staff as appropriate,administer training
  • Create photographicdatabase and manage photographic data
  • Manage timeline andtrack clinical study progress. Present on-going findings to cross-functionalteam at weekly meetings and ad hoc meetings
  • Oversee data input,analysis and management, write clinical study reports
  • Assist in thepreparation of high quality presentation materials and abstracts in concertwith physician KOLs for professional medical meetings (ASLMS, AAD, etc.)
  • Bachelors’ degree inscientific/clinical related discipline
  • At least 3-4 years experience inclinical research/operations with significant contribution to the success of aclinical study, from planning to close-out
  • In-depth understanding of medicaldevice industry requirements and standards including ICH guidelines, GCP andCFR
  • Technical expertise in thevarious aspects of the clinical study process for medical devices
  • Proficient in development ofclinical study documentation (e.g. protocol, informed consent forms, casereport forms, templates)
  • Experience overseeing day-to-dayactivities of clinical studies
  • Experience managing relationshipwith vendors, contractors, investigators and IRBs in a clinical study context
  • Excellent cross-functionalcollaboration and communication skills
  • Flexibility to accommodate travelof approximately 50%
  • Proficiency with MS Office suite(Word, Excel, PowerPoint)
  • Previous experience in thedevelopment of products in the dermatology or plastic surgery fields is a plus
  • Familiarity with photometric datahandling and analysis is a plus

EEO Minorities/Females/Protected Veterans/Disabled

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