Senior Clinical Research Associate I

2 weeks ago


Morrisville, United States Caidya Full time
Job Title: Senior Clinical Research Associate I

Job Overview:

The Senior Clinical Research Associate I is responsible for monitoring investigational sites to ensure subject safety and providing high-quality data review and reporting in compliance with Caidya and/or client Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines, ISO14155, and other applicable regulations.

Key Responsibilities:

  • Provides support to Project Team and Clinical Operations Team.
  • Maintains working knowledge of protocols and Monitoring Plans for assigned projects.
  • Demonstrates strong written and verbal communication skills.
  • Serves as primary contact for assigned research sites.
  • Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period.
  • Responsible for scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits, and close-out visits according to the Monitoring Plan.
  • Ensures assigned sites are conducting studies according to protocol requirements or investigational plan and applicable regulations and guidelines.
  • Verifies that the rights and well-being of trial subjects are protected.
  • Reconciles site regulatory binder assuring collection and completeness of regulatory documents.
  • Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out.
  • May support translations of essential documents.
  • May support submission of trials to IRB/IEC and regulatory authorities.
  • Verifies that written informed consent was obtained before each subject's participation in the trial.
  • Verifies that the investigator is enrolling only eligible subjects.
  • Performs source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan.
  • Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.
  • Verifies the quality of all recorded data.
  • Issues and ensures timely resolution of all data queries remotely or at investigator site.
  • Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
  • Verifies and supports the recording and reporting of adverse events/serious adverse events.
  • Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.
  • Ensures that sites have sufficient project-specific supplies.
  • Manages investigative sites in respect to the trial conduct and motivates sites to meet study goals.
  • Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.
  • Delivers quality written trip reports, confirmation, and follow-up letters within timelines of SOPs and Monitoring Plans.
  • Attends and participates in team teleconferences and training.
  • Participates in relevant trial meetings, e.g., Kick off, Investigator, and Monitor meetings.
  • Participates in site audits, as requested.
  • May conduct site and study feasibility assessments.
  • May be involved in the development of monitoring guidelines and tools.
  • Provides input into study documentation and monitoring worksheets.
  • Upholds the confidentiality agreements with all clients and colleagues outside Caidya.
  • Pays attention to signals of fraud, misconduct, and escalates per Caidya SOP.
  • Work according to the Caidya Quality Management System and actively participate in giving feedback and suggesting improvements to current processes.
  • Work according to the project-specific timelines and budget agreement, which has been agreed upon with the sponsor.
  • Accurately document the time spent per project in the Caidya time allocation system.
  • Demonstrates flexibility and adaptability.
  • Proactively identifies, manages, escalates (as needed), and resolves site issues effectively and independently.
  • Other duties as assigned by Clinical Operations Manager/Project Manager and per project-specific requirements.
  • May participate in delivering Clinical Monitoring portion of a bid defense presentation.
  • Supervisory Responsibilities:
  • None
  • Job Requirements:
  • Education:
  • 4-year college graduate, preferably with a healthcare or life science degree.
  • In lieu of a degree, candidates with 2 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
  • Experience:
  • Minimum of 3 years of experience in on-site monitoring clinical studies.
  • Skills/Competencies:
  • Strong written and verbal communication skills.
  • Strong interpersonal skills.
  • Strong monitoring skills to independently conduct all types of site monitoring visits.
  • Good documentation skills; good command of English and the local language in the area of activity (reading, writing, understanding).
  • Proficient computer skills, including Microsoft Office.
  • Comprehensive knowledge of GCP/ICH guidelines.
  • Proficiency in medical terminology.
  • Able to exercise judgment within defined procedures and practices and to determine appropriate action independently.
  • Attention to detail.
  • Problem-solving skills.
  • Ability to work in a matrix environment.
  • Strong time management and organizational skills.
  • Capabilities:
  • Ability to drive an automobile and have a valid driver's license, if applicable.
  • Valid passport required in the case of international business travel.
  • Ability to travel up to 80%.
  • #LI-NB1
  • #LI-REMOTE

The company will not accept unsolicited resumes from third-party vendors.



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