Sr. Clinical Research Associate - Remote

Company: TE Connectivity
Location: Miami
Posted on: May 28, 2023

Job Description:

Sr. Clinical Research Associate - Remote
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
Job Overview
Manage and monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP, and all applicable regulatory requirements.
Responsibilities:

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  Manage and monitor clinical trials independently, across multiple studies, to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH/GCP guidelines
  
  
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  Provide input on clinical study documents such as Protocols, ICFs, Source Documents, and Monitoring Plans
  
  
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  Initiate clinical trials at investigative sites, instruct site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
  
  
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  Identify study-related issues, confirm resolution, and ensure proper documentation through event system
  
  
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  Record site visit activities, including but not limited to, observations of clinical conduct, instructions/training given to sites, and action items to be completed as required by OPs or other contractual obligations
  
  
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  Review and verify accuracy of clinical trial data collected, either onsite or remotely, including query resolution
  
  
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  Assist with generating contents list of Enrollment Kits and other Study Supplies, as requested
  
  
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  Facilitate supply management and ensure clinical sites have necessary supplies to conduct studies according to applicable protocols
  
  
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  Assess IP accountability, dispensation, and compliance at the investigative sites
  
  
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  Ensure all required training is completed and documented
  
  
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  Perform essential document site file reconciliation
  
  
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  Ensure maintenance of essential documents in TMF to facilitate timely transfer to client
  
  
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  Serve as main contact for project-specific communications with investigative sites
  
  
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  Work closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
  
  
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  Provide regular site status information to team members, trial management, and updates trial management tools
  
  
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  Participate in team meetings with clients, as needed, and keep project team members informed of study progress, issues and potential timeline delays by preparing weekly updates, as requested
  
  
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  Research and learn project indication
  
  
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  Serve as resource for and interact with other functional areas to resolve site issues and facilitate trial timelines
  
  
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  Analyze process workflow; implement operational changes in coordination with Sr Management
  
  
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  May be assigned additional Clinical Operations tasks
  
  
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  Help create a fun, rewarding and collaborative environment
  
  
  What your background should look like:
  
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    5 years of Clinical Research experience; IVD experience preferred
    
    
    
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    Bachelor's degree in the Life Sciences or related field required, or equivalent
    
    
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    Pursuing a certification as a CCRP or CCRA through recognized professional organization
    
    
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    Thorough knowledge of GCP, GLP, ICH guidelines and other U.S. and international clinical regulatory requirements
    
    
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    Strong work ethic and demonstrated ability to deliver assignments on time
    
    
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    Ability to travel (up to 80%)
    
    
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    Ability to handle difficult situations professionally and maintain a professional and caring demeanor
    
    
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    Proven ability to collaborate in a team environment and work independently
    
    
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    Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
    
    
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    Must be responsible, creative and highly motivated
    
    
    Works Closely With:
    CTAs, Clin Ops Specialists, CRAs, Reg CRA Supervisors, PMs, Dir of Clin Monitoring & Data Management, Sr Mgr of Clin Ops, Dir of Clinical Programs
    Competencies
    SET : Strategy, Execution, Talent (for managers)
    ABOUT TE CONNECTIVITY
    TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications and the home. With approximately 80,000 employees, including more than 7,500 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.
    COMPENSATION
    --- Competitive base salary commensurate with experience: $93,400 - $140,000 (subject to change dependent on physical location)
    --- Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
    --- Total Compensation = Base Salary + Incentive(s) + Benefits
    BENEFITS
    --- A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.
    EOE, Including Disability/Vets
    Location:
    Miami, FL, US, 33128
    City: Miami
    State: FL
    Country/Region: US
    Travel: 50% to 75%
    Requisition ID: 100630
    Alternative Locations:
    Function: Clinical Operations
    TE Connectivity and its subsidiaries, affiliates, and operating units (collectively, the "Company") is committed to providing a work environment that prohibits discrimination on the basis of age, color, disability, ethnicity, marital status, national origin, race, religion, gender, gender identity, sexual orientation, protected veteran status, disability or any other characteristics protected by applicable law or regulation.

Keywords: TE Connectivity, Miami , Sr. Clinical Research Associate - Remote, Healthcare , Miami, Florida