CRA- Analyst Job at Orison Solutions, Minneapolis, MN

c2QxTzJpZ2hLcGRLM1ZqeXZKMGFmektN
  • Orison Solutions
  • Minneapolis, MN

Job Description

Responsibilities:

  • Work to ensure that trials are adhere to study protocols, applicable SOPs, FDA regulations, International Conference for Harmonization (ICH) / Good Clinical Practices (Google Cloud Platform) guidelines, and government regulations.
  • Evaluate, monitor, and document study results.
  • Exercise good clinical judgment and demonstrate professional conduct when interacting with investigational site personnel and sponsor representatives.
  • Monitor Clinical Research Organizations (CROs) and study management of multiple sites.
  • Additional duties include: document retrieval, archival, informed consent release forms, amendments, etc.
  • Responsible for the management of designated clinical trials including investigator recruitment and selection, analysis of potential patient recruitment, preparation of trial related documentation (protocols, case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organizing Ethics committee submissions with follow through to ensure successful outcome, investigator and study staff training.
  • Ensure procedures are in place for appropriate optimization of patients into the clinical trial.
  • Planning the requirements for clinical trial material (CTM), ordering CTM, setting up and monitoring the systems whereby the CRA can ship CTM to the investigator, maintaining procedures to account for the CTM, checking the expiration of CTM, and requesting extensions if necessary.
  • Approximately 15% local on-site co-monitoring

Qualifications:

  • Bachelor's degree required
  • 1-3 years combined experience with at least one of the following:
  • Medical device research experience
  • In-house pharma CRA experience (strictly Regional CRA experience will be considered)
  • Clinical Research Coordinator (site-level Study Coordinator) experience is required in lieu of CRA experience
  • On-site monitoring experience is required
  • Electronic Data Capture (EDC) experience required (non-discriminatory)
  • Excellent oral and written communication skills

Job Tags

Local area

Similar Jobs

JRD Transportation Inc

OTR Class A CDL Team Driver Job at JRD Transportation Inc

 ...delivery Pro-active communication Requirements: ~ Valid CDL and medical card ~ Must pass Drug & Road test. ~ Ability to drive safely, irrespective of the weather or time of day. ~12 Months of experience. Please call or text us at (***) ***-**** for... 

NECSWS

React Developer (Front-end, Next.js), SC cleared Job at NECSWS

 ...Role can be Hybrid or Remote Subject to Location NEC Digital seeks a Front-end React Developer. The successful candidate will be responsible for developing and maintaining web applications utilising React and Next.js, with a focus on delivering secure solutions as cloud... 

Dragons Group

Social Media Copywriter (Wellness&Lifestyle) Job at Dragons Group

Location: New YorkAbout Us We are Dragons, a global creative agency working with bold brands to build cultural relevance, connection, and...  ...calendars and reactive opportunitiesPartner closely with AD and Video Creator to shape final outputContribute to reactive... 

Tulsa Honor Academy

Discipline Specialist Job at Tulsa Honor Academy

 ...provide our scholars access to more life opportunities through educational equity, which will empower them to live a life of independence...  ...Believe that scholars want and need to be held to a higher standard and that scholars are capable of making good choices... 

Global Dimensions

Operational Language Analyst - Somali (OLA 3) - TS/SCI CI Poly - MD Job at Global Dimensions

 ...instruction, IT, cyber security, and intelligence (analysts, CI, HUMINT, SIGINT, etc.). Global Dimensions is currently seeking Somali OLAs (Level 3) for positions at Fort Meade, Maryland , near Columbia, Maryland. Requirements ~ Must have a current TS/SCI...