Clinical Research Associate II – Proxima

JOB DESCRIPTION

Performs monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Proxima and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements.  Performs all tasks routinely and independently, seeking guidance as needed.

A DAY IN THE LIFE

  • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits, on-site or remotely, ensuring regulatory, ICH-GCP, monitoring plan and protocol compliance.
  • Conducts  source  document  review  of  appropriate  site  source  documents  and  medical  records. Verifies the required clinical data entered in the case report form is accurate and complete and utilizes query resolution techniques remotely and on-site.
  • Performs  investigational  product  inventory  and  reconciliation,  reviewing  storage  and  security   parameters.   Verifies   IP   dispensation   and   accountability   according   to   the   protocol.
  • Verifies site informed consent process is adequately performed and documented for each subject.
  • Routinely  reviews  the  Investigator  Site  File  for  accuracy,  timeliness  and  completeness.  Reconciles the ISF with the Trial Master File and collects any outstanding documents.
  • Serves as primary point of contact with study site personnel. Documents all activities and communications with the site via confirmation letters, follow-up letters, monitoring visit reports,  communication  logs  and  other  required  project  documentation.  Follows  up  on  action items to ensure timely completion.
  • Trains  site  staff  on  protocol,  study  procedures,  EDC  and  any  other  study  specific  requirements or systems
  • Prepares  for  and  attends  Investigator  Meetings  and/or  sponsor  face-to-face  meetings.  Participates  in  clinical  monitoring/project  staff  meetings  and  attends  clinical  training  sessions according to the project specific requirements. 
  • May  review  draft  protocols,  eCRFs,  study  manuals  and  other  study-related  documents  and templates, as requested by the Project Manager
  • Prepares  and  coordinates  documentation  with  site  for  IRB  applications  and  renewals,  as  needed.
  • Routinely  communicates  with  internal  Proxima  and  Sponsor  project  teams,  escalating  issues and develops action plans.
  • May conduct evaluation visits and field training of CRA Is, and other CRA IIs
  • Attendance   at   internal   Proxima   meetings,   completion   and   proper   submission   of   timesheets and documentation of training
  • Adherence to Proxima or client Standard Operating Procedures (as applicable)
  • Professionally represents Proxima in business interactions

MUST HAVE KNOWLEDGE AND SKILLS

  • Bachelor’s   degree,   ideally   within   a   scientific   or   healthcare   field,   a   healthcare   certification, or an equivalent combination of education, training and experience.
  • A minimum of 2 years field monitoring experience with 5 years overall clinical research experience. 
  • Must have thorough understanding of current ICH/GCP and FDA  regulations  pertaining  to clinical research.

NICE TO HAVE KNOWLEDGE AND SKILLS

  • Ability and willingness to travel domestically 20%-80%
  • Strong  interpersonal  skills  and  ability  to  forge  relationships  with  clinical  sites  and  colleagues. 
  • Excellent oral and written communication skills, with ability to articulate issues. 
  • Self-management skills, including ability to multi-task. 
  • Attention to detail and accuracy in work. 
  • Well organized, with strong problem solving and time management skills. 
  • Proficient in the use of Microsoft Office applications.

For more information, go to https://www.proximacro.com/careers