Job Description: SENIOR CLINICAL RESEARCH ASSOCIATE (SCRA) Location: Canada

JOB OVERVIEW: The Senior Clinical Research Associate I monitors investigational sites to ensure subject safety and provide high quality data review and reporting in compliance with the Company 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.

IMPORTANT HIGHLIGHTS:

• This is a contract position, estimated to last 6 months. Future extensions will be based on corporate needs and individual performance.
• Part-time role averaging ~20 hours per week (some weeks may be higher, others lower).
• Responsible for sites across Canada (locations will be discussed during interviews).
• Prior CRA experience monitoring oncology studies is required.

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.
• Upholds the confidentiality agreements with all clients and colleagues outside Company.
• Pays attention to signals of fraud, misconduct and escalates per Company SOP.
• Works according to the Company Quality Management System and actively participates in giving feedback and suggesting improvements to current processes.
• Works according to the project-specific timelines and budget agreement, which has been agreed upon with the sponsor. Accurately documents the time spent per project in the Company time allocation system.
• May conduct project co-monitoring visits.
• 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.
• 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 mentorship, training and direction to Clinical Research Associates when needed.
• May conduct SOV and QAV assessments.

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 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.
• Monitoring experiences in several different indications and study types.
• 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.
• Attention to detail.
• Strong problem-solving skills.
• Strong presentation 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 is preferred, in case international business travel becomes requested.
• Ability to travel up to 80%.