Sr. Clinical Research Associate - Remote
Company: TE Connectivity
Location: Miami
Posted on: May 28, 2023
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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:
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
Provide input on clinical study documents such as Protocols, ICFs,
Source Documents, and Monitoring Plans
Initiate clinical trials at investigative sites, instruct site
personnel on the proper conduct of clinical trials, and close
clinical trials at investigative sites
Identify study-related issues, confirm resolution, and ensure
proper documentation through event system
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
Review and verify accuracy of clinical trial data collected, either
onsite or remotely, including query resolution
Assist with generating contents list of Enrollment Kits and other
Study Supplies, as requested
Facilitate supply management and ensure clinical sites have
necessary supplies to conduct studies according to applicable
protocols
Assess IP accountability, dispensation, and compliance at the
investigative sites
Ensure all required training is completed and documented
Perform essential document site file reconciliation
Ensure maintenance of essential documents in TMF to facilitate
timely transfer to client
Serve as main contact for project-specific communications with
investigative sites
Work closely with other clinical team members to facilitate timely
resolution of trial and/or clinical issues
Provide regular site status information to team members, trial
management, and updates trial management tools
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
Research and learn project indication
Serve as resource for and interact with other functional areas to
resolve site issues and facilitate trial timelines
Analyze process workflow; implement operational changes in
coordination with Sr Management
May be assigned additional Clinical Operations tasks
Help create a fun, rewarding and collaborative environment
What your background should look like:
5 years of Clinical Research experience; IVD experience
preferred
Bachelor's degree in the Life Sciences or related field required,
or equivalent
Pursuing a certification as a CCRP or CCRA through recognized
professional organization
Thorough knowledge of GCP, GLP, ICH guidelines and other U.S. and
international clinical regulatory requirements
Strong work ethic and demonstrated ability to deliver assignments
on time
Ability to travel (up to 80%)
Ability to handle difficult situations professionally and maintain
a professional and caring demeanor
Proven ability to collaborate in a team environment and work
independently
Must be a team-player, punctual and reliable, dependable and
flexible in adapting to change in a multi-disciplinary, fast-paced
work environment
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
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