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Job Runner

 
  • Category: Healthcare
  • Education: Bachelors Degree
  • Employment Length: fulltime
  • Source: Business
  • Ad #: 11776
 
Via: kellyjobsmnetwork Apply / More Info
 
Full Details

Clinical Research Associate (CRA) - Chula Vista, CA

Every day Kelly Scientific Resources (KSR) connects scientific professionals with opportunities to advance their careers.  We currently have an exciting opportunity for a Clinical Research Associate(CRA) to work with a growing company in Chula Vista CA.

This is a Long Term Contract position with up to 85% travel required.  

Summary:  The Clinical Research Associate will conduct site monitoring of clinical research studies according to Standard Operating Procedures SOPs and ICH/GCP/GMP/GLP guidelines. CRA conducts site management review and oversight activities for clinical research studies.

Responsibilities:

  • Responsible for all aspects of study site monitoring including process monitoring visits, pre-study visits, site initiation visits, routine monitoring visits and close-out visits of clinical sites, and maintenance of study files, with or without guidance.
  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
  • Identify, track, and follow up on all adverse events (AEs) and serious adverse events (SAEs); ensure all applicable SAEs are reported to sponsor and regulatory authorities.
  • Ensure the accuracy and integrity of the data submitted on electronic or paper case report forms (CRFs), or other data collection tools, by comprehensive source document review. Monitor data for missing or discrepant data.
  • Ensure that all required monitoring tasks are conducted according to SOPs, established guidelines, work instructions, and project plans (e.g. monitoring plan).
  • Conduct eCRF/CRF review, query generation, and resolution against established data review guidelines, with or without direct supervision.
  • Assist with recruiting investigators, feasibility collection, and general collection of investigator documents.
  • Create spreadsheets, tracking tools, Word documents, etc. to update and track study milestones and progress.
  • Attend investigators’ meetings, project team meetings, and teleconferences, as needed.
  • Understands and applies knowledge regarding local, state, country regulations (e.g., HIPAA, CA Bill of Rights), International Conference on Harmonization (ICH), and Good Clinical Practices (GCPs).
  • Participates, as requested, in Continuous Quality Improvement (CQI) processes.
  • Responsible for attending all required training, assisting in training of other CRAs, as well as participation in all other applicable training.
  • Participates in annual/ad hoc monitoring assessments including but not limited to remote assessment visits, quality control visits, and training and mentoring visits.

Travel Requirements: 

  • Able to travel via airplane, train, or motor vehicle to respective research sites or investigator meetings.
  • Must be able to travel out of the local office or from home up to 85% of the time, including overnight stays at hotels or other designated facility.
  • Must be able to drive and have a valid driver’s license.

Minimum Requirements:

  • Bachelors degree in life science or certification in related allied health profession from an appropriately accredited institution (e.g., nursing, respiratory, certification, medical or laboratory technology).
  • Minimum of 2 years experience in clinical research 
  • Understanding of ICH/GCP guidelines and including a basic understanding of regulatory requirements and the clinical trial process or equivalent combination of education and experience.
  • Possess knowledge of medical terminology, clinical research acronyms, and medical/scientific abbreviations.

Why Kelly?

As a Kelly Services employee, you will have access to numerous perks including:

  • Exposure to a variety of career opportunities as a result of our expansive network of client companies
  • Career guides, information, and tools to help you successfully position yourself throughout every stage of your career
  • Access to more than 3,000 online training courses through our Kelly Learning Center
  • Weekly pay and service bonus plans
  • Group-rate insurance options available immediately upon hire*

Apply Today!  Questions?  Call Kevin at 602.548.1774 or email kevin.lau@kellyscientific.com 

*Available for purchase and administered by a designated third-party vendor

 
Map: Chula Vista CA
 
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