Job Description:

Job Overview:

The Senior Clinical Research Associate II 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 regulations. Builds, manages and supports strong 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 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.
• 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 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.
• Provides input into study documentation and monitoring worksheets.
• Uphold the confidentiality agreements with all clients and colleagues outside Clinipace Clinical Research.
• Pays attention to signals of fraud, misconduct and escalates per Clinipace SOP.
• Work according to the Clinipace 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 Clinipace time allocation system.
• May perform Trip Report review, management, resolution and escalation.
• May conduct project co-monitoring visits
• May conduct project team training.
• May conduct Team calls and Sponsor calls (as needed).
• May provide project-specific performance feedback.
• May serve as site contact for protocol clarifications and subject enrollment.
• May manage Protocol Deviation documentation, tracking, and escalation.
• May relate project status and issues to Project Manager and/or CRAs.
• May serve as Sponsor contact for monitoring/site issues.
• May assist the Project Manager with coordination and management of the project budget, grant administration and project invoicing.
• Attends and participates in team teleconferences/meetings providing mentoring and training.
• Participates in relevant trial meetings, e.g. Kick-off, Investigator, and Monitor meetings, and provides support, as requested.
• Demonstrates flexibility and adaptability.
• Assists project team in development of monitoring guidelines and tools.
• Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently.
• Provides support to Project Team.
• May conduct SOV and QAV assessments
• Provides mentorship, training and direction to Clinical Research Associates when needed.
• 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:

No supervisory responsibilities.

Job Requirements:

• Education
  • 4-year college graduate, preferably with a healthcare or life science degree.
  • In lieu of a degree, candidates with 4 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
• Experience
  • Minimum of 6 years of experience in on-site monitoring of clinical studies
  • Monitoring experience in complex therapeutic indications, across multiple therapeutic areas.
  • Experience in all areas of monitoring (on-site, remote, etc.)
• 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.
  • Strong attention to detail
  • Superior problem-solving skills
  • Assist in training/mentoring guidance
  • Strong 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 up to 80%.

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