Contract Sr. Clinical Research Associate

The Contract Sr. Clinical Research Associate monitors investigational sites to ensure subject safety and provide 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 local regulations. Builds, manages and supports strong site relationships while liaising between the Sponsor and assigned sites.,

• Provides support to Project Team and Clinical Operations Team.
• Maintains strong 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 the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.
• Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines.
• Verifies 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.
• 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 high quality written trip reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans.
• Participates in site audits, as requested.
• May conduct site and study feasibility assessments.
• 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 project-specific timelines and budget agreement, which has been agreed upon with the sponsor. Accurately document the time spent per project in the CPWW time allocation system.
• May conduct project co-monitoring visits and/or training visits.
• May serve as site contact for protocol clarifications and subject enrollment.
• Attends and participates in team teleconferences/meetings.
• Attends investigator meetings.
• Demonstrates flexibility and adaptability.
• Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently.
  
  + 4 year college graduate, preferably with a healthcare or life science degree.
+ In lieu of a degree, candidates with 3 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 of clinical studies.
• Skills/Competencies
+ Strong written and verbal communication skills + Strong interpersonal skills + Expert 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) + Strong 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. + Exceptional attention to detail + Superior problem-solving skills + Assist in training/mentoring guidance and presentation skills. + Ability to work in a matrix environment + Exceptional 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.