Clinical Research Associate II

Job Description:

Job Title: Clinical Research Associate II **

Job Location: Homebased (United States)

Job Overview:**

The Clinical Research Associate II monitors investigational sites to ensure subject safety and provides high quality data review and reporting in compliance with the Caidya and/or client Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, ISO14155, and other applicable regulations. Builds, manages and supports site relationships while serving as liaison between the Sponsor and assigned sites. **

Job Duties and 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 guideline and tools.
• Provides input into study documentation and monitoring worksheets.
• Uphold 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 1 year 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%.

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