• Company:
  MedFocus Pharmaceutical Research Opportunities
• Location:
  New Haven, CT
• Status:
  Full Time
  Temporary/Contract/Project
• Education:
  Bachelor's Degree
• Industries:
  Biotechnology/Pharmaceuticals
• Occupations:
  Biological/Chemical Research
  Clinical Research
  Pharmaceutical Research
• Work Experience:
  5+ to 7 Years
• Job Category:
  Biotech/R&D/Science
• Career Level:
  Experienced (Non-Manager)
• Contact:
  Gail Condon
• Email:
  Apply by Email
• Reference Code:
  0000070098

Since 1993, MedFocus has succeeded in meeting the contract staffing needs of our consultants and clients faster and more effectively than our competition through "specialized" recruiting exclusively in the pharmaceutical arena. By staying focused, MedFocus has become the firm of choice for both client companies and our consultant job seekers.

North East Regional CRA III

NORTH EAST CRA III COMPANY INFO: MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel. Our client embraces research and science - bringing innovative ideas, products and services to advance the health and well-being of people and is seeking to add a North East CRA III to their team in New York City, Johnson City NY, upstate NY, Newhaven CT, Boston MA. RESPONSIBILITIES: •    Responsible for IDE site management and clinical monitoring in accordance with contractual agreements, department guidelines, work instructions, applicable federal and state regulations, ICH guidelines. Travel approximately 50-60%. Periodic travel to sponsor headquarters for up to 1 week at a time required. Efficiently manage between 6-8 study sites. •    Monitoring activities to include review of: device accountability records, regulatory records, subject eCRFs and source documentation, subject enrollment records, and engage CRC and PI concerning visit findings and action plans. •    Prepare pre- and post-monitoring visit correspondence with good attention detail and high level of quality •    Active engagement and collaboration with study sites to ensure compliance with sponsor as well as IRB reporting requirements •    Active engagement and collaboration with study sites to resolve queries and open action items in a timely manner •    Proactive identification and management of potential quality concerns •    Training of new study site personnel on protocol and study requirements •    Provide real-time updates to Project Manager and sponsor Project Team. •    Position may be remote/home-based depending on applicant’s location and needs of the study. •    Ability to work independently with minimal oversight if remotely based. •    Primarily a site monitoring position for DISCOVER. •    At least 3-5 years experience required, preferably with devices. QUALIFICATIONS: •    BA/BS in nursing and/or life or health sciences •    A minimum of 5 years experience in clinical research; 3+ years as a clinical site monitor •    Experience with device trials strongly preferred •    Sound working knowledge of the Code of Federal Regulations, Good Clinical Practice and ICH guidelines as applied to drug trials •    Ability to establish and maintain effective working relationships with study site personnel other team members •    Ability to communicate in a professional but results-driven manner with both site coordinators as well as surgeons •    Sound knowledge of medical terminology, particularly spine and related pathologies •    Able to review and interpret patient medical records and draw concise conclusions •    Strong knowledge working in Microsoft Office Programs and other software packages •    Ability to problem-solve effectively with management, team members, clients and vendors •    Traits for in the ideal candidate: Driven; high ethical standards; enthusiastic team member; critical mind; invested in project; highly detailed oriented; bright; fast learner; proactive vs. reactive. •    MUST have medical device experience •    Ideally have spine or artificial disk experience MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.