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Sr. Clinical Trial Associate/Clinical Trial Associate-Pharmaceutical

Company: Grimaldi Recruitment Services
Location: Mountain View
Posted on: May 19, 2019

Job Description:

SUMMARY This company is seeking an exceptional experienced Sr. Clinical Trial Associate/Clinical Trial Associate to play a key role in its administration and support of the execution of clinical studies and program management. She/he will provide organizational and trial support and work closely with clinical operations team to ensure operational strategies are met. This role offers an exciting opportunity for a talented professional to contribute their clinical trial expertise as well as develop significant career experience in the emerging field of regenerative medicine. The Sr. Clinical Trial Associate/Clinical Trial Associate is responsible for the day-to-day support of operations of 1-4 clinical trials, in collaboration with internal and external partners, to ensure delivery of trial related activities with complexity start-up, conduct, close-out activities are conducted with the highest level of ethical and safety standards and are in compliance with Good Clinical Practice (GCP) and all regulatory policies. RESPONSIBILITIES

  • Provide support for day-to-day operational execution of clinical studies in collaboration with clinical operation team and program lead.
  • Collaborate with internal cross-functions and external partners, such as CRO and/or vendors to ensure operational strategies are achieved in line with goals.
  • Support the collation of feedback on study level documentation and ensures appropriate updates are made.
  • Contribute to the development of tracking tools to meet the needs of the team and to facilitate reporting to the study metrics. Must be able to effectively combine data from multiple systems.
  • Establishes the set-up of archives for essential documents including trial master file. Responsible for creation of TMF plan, ongoing QC, remediation of findings.
  • Support the clinical operations in review of regulatory document for site activation and continued compliance.
  • General organizational responsibilities include calendar management, travel coordination, expense reporting for program leader and general support for meetings including but not limited to meeting coordination, set-up, agenda, and minutes.
  • Organize Investigator Meeting planning, Industry Meeting and other necessary meetings to support the clinical programs.
  • Support clinical operations in external vendor contracting, purchase order set-up, review, processing and tracking of invoices
  • Support the upkeep of the clinicaltrial.gov registry and other respective registries (i.e. NIH) as necessary.
  • Serve as a point of contact on clinicaltrial.gov/other registries and coordinate response to patient and community outreach related to the clinical trials, including any follow-up.
  • Responsible for tracking of INDSRs/SUSARS and ensuring reporting to PI and IRBs as necessary. Ensure all key site stakeholders have access to safety database and reports throughout the study.
  • May provide vendor management and training relative to the execution of clinical programs such as TMF, IRT, etc.
  • Support the clinical operations team in tracking and requesting Clinical Disclosure Agreements (CDAs), Site Contracts and Amendments, and other respective legal agreements
  • Support activation and renewal of the clinical trial insurance
  • Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study activities remains on track
  • Supports planning and shipping activities for clinical and non-clinical supplies
  • Maintains internal Clinical Operations databases and document repositories
  • Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
  • Under supervision may assist in review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
  • Support the collation of feedback on study level documentation and ensures appropriate updates are made.
  • May monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required
  • Identify and participate in creation of clinical operations SOPs, best practice and standards across study team and organization as needed.
  • Ensure adherence to ICH/GCP/local regulations, and SOPs. QUALIFICATIONS
    • At least 2+ years of relevant experience and BA/BS relevant in Scientific Discipline; or 2+ years of experience and an RN (2 or 3 year certified). Potential candidates with equivalent experience and accomplishments will be considered.
    • Experienced with multi-center international studies is preferred.
    • Must be familiar with routine medical/scientific terminology.
    • Experience as a clinical research monitor/clinical research coordinator is a plus. Experience with surgical studies is a plus.
    • Experience managing CROs, central laboratories, central imaging centers and other clinical study vendors is a plus.
    • Knowledge of GCP and ICH guidelines, and local regulations.
    • Proficient computer skills with MS Office PowerPoint, Word, Project, Excel and Outlook is required.
    • Ability and willingness to travel as required KEY ATTRIBUTES
      • Demonstrated energy and passion. A commitment to helping deliver clinical trial achievements.
      • Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
      • Able to work under general supervision, independently motivated, detail oriented and good problem-solving ability
      • Able to handle routine and impromptu assignments with minimal or no supervision.
      • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
      • Strong interpersonal, communication and leadership skills, including the ability to build relationships both internal and external. Ability to work in an international environment with internal and/or external partners.
      • A quick study with excellent written and verbal communications and professional presentation skills and demeanor.
      • Key attributes: problem solver, creative, positive mental attitude, direct, take-charge, good sense of humor.
      • Enjoy collegial open discussions; able to thrive in the absence of egotism.
      • An outstanding work ethic, high-integrity, team player attitude.

Keywords: Grimaldi Recruitment Services, San Francisco , Sr. Clinical Trial Associate/Clinical Trial Associate-Pharmaceutical, Healthcare , Mountain View, California

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