Senior Clinical Research Associate Iii

**Job Title**:
**Senior**
**Clinical Research Associate III (Homebased)**

**Job Location**: France

**Job Overview**:
**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.
- 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.
- 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 provide team training.
- May conduct Team calls and Sponsor calls (as needed).
- May provide project-specific performance feedback.
- 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 and assumes additional roles on the team as necessary.
- Provides mentorship, training and direction to Clinical Research Associates when needed.
- May conduct SOV and QAV assessments
- 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.
- Experience
- Minimum of 10 years of experience in on-site monitoring of clinical studies.
- Monitoring experience in multiple, complex indications and study types including inpatient, FIH, Phase I, critical care.
- Experience in all ar