CRA II ~ Sr CRA I (Brisbane)

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients' lives around the world.

Summary:

The Senior Clinical Research Associate I (Sr CRAI) will complete project activities associated with monitoring functions of Phase I-IV clinical research studies whilst developing mastery and a thorough understanding of the drug development process. Performs monitoring functions to assess the progress of clinical studies at assigned investigative sites (either on site or remotely) to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. May assume clinical functional leadership tasks as assigned, acting as Lead CRA for a study.

Essential Functions:

1. Monitoring

• Assures compliance with local regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs.
• Critically evaluates adequacy of investigator sites (qualifications, facilities, equipment and performance). Performs all tasks required for onsite/remote monitoring including but not limited to source document review (SDR) and source document verification (SDV). Plans and conducts study initiation visits for investigator sites. Proactively and with minimal oversight applies planning techniques for monitoring visits to ensure efficient and effective monitoring. Plans and conducts study close-out visits for investigator sites. Manages and prioritizes workload effectively.
• Completes and submits monitoring visit reports in accordance with SOP/Work Instructions or Sponsor requirements as agreed in the scope of work. Maintains awareness of key study performance indicators for own sites. Supports subject recruitment and retention strategies. Updates study and subject status information. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from contact to contact and routinely anticipates/ identifies potential issues and implements corrective actions. Seeks guidance to resolve complex issues.
• Ensures all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements/data collection tools. Serious Adverse Event (SAE) reporting requirements, Investigational Product (IP) management, bio sample management and subject reported outcomes instruments as applicable. Follows standard process for documentation of site contacts (visits, phone, email etc.).
• Extensive travel may be required, 50% to 75% on a regular basis.

1. Subject Rights & Wellbeing-Verifies that the process of obtaining informed consent has been adequately performed and documented for each subject. Demonstrates diligence in protecting the confidentiality of each subject. Assesses factors that might affect subject's safety and clinical data integrity at an investigator site such as protocol deviation/violations and pharmacovigilance issues.

1. Reporting and Tracking

• Maintains site performance metrics and implements action plans for sites not meeting expectations with minimal guidance.
• Maintains current regulatory documentation for assigned sites according to Essential Regulatory Document Guidelines and/or regulatory project plan.
• Maintains up to date information within the deployed CTMS.
• Audit - Maintains all areas of cover as assigned (site & study level) to audit readiness standards and supports preparation for audit and required follow up actions.
• May be assigned clinical team lead tasks such as trip report review and oversight of CRA/CMA team tracking.
• Demonstrates sufficient time management to achieve required deliverables: consistent on time expense reports, timecard submissions, trip report submissions/finalization, monitoring visit frequency as per Statement of Work (SoW), Clinical Monitoring Plan (CMP).

1. Data Management- Uses analytical thinking to review data recorded in source documents for accuracy and completeness, and in accordance with the clinical monitoring and associated plans. Verifies that the clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. If acting in a Lead CRA (LCRA) role ensures understanding of data at the site and maintains a current tracker of data volume. Performs these tasks routinely and independently, seeking guidance as needed.

1. Investigational Product-Performs IP inventory, reconciliation and reviews storage and security. Verifies that the IP has been dispensed and administered to subjects according to the protocol. Verifies process and identifies any issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Applies experience and proactive critical thinking to identify any issues or compliance trends related to site IP.

1. Documentation and Record keeping-Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with that of the trial master file (TMF). Ensures the investigator site is aware of the requirement of archiving essential documents in accordance with the local guidelines and regulations. Verifies site compliance with requirements for electronic data capture. Applies experience and proactive critical thinking to identify any issues or compliance trends related to site documentation and record keeping.

1. Communication-Maintains effective, accurate, and timely communication with site staff and project team, ensures appropriate issue escalation. Shows independence in managing routine and complex tasks and proactively communicating status. Keeps project leadership apprised of team issues, seeking guidance as needed. Demonstrates effective conflict resolution. Occasionally seeks guidance to resolve more complex issues. Uses the appropriate mode of communication in relaying information. Participates in global conference calls and meetings to review progress of ongoing clinical trials.

1. Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. As Lead CRA may also prepare and present information in meetings.

1. Attends clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements

1. May provide training or mentorship to more junior-level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.

1. May be mentored and assigned clinical team leader tasks under supervision of an experienced CTL, or operational line manager.

Other Responsibilities:

1. Maintains required and functional job specific training.

1. Performs other work-related duties as assigned.

1. As a representative of the Company, demonstrates professional attire, attitude and behavior in meetings & teleconferences, site visits and interactions, and interpersonal activities in general

Requirements :

BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience . Extensive experience as a CRA with a thorough understanding of SOPs, WIs, FDA and local regulations as well as ICH-GCP guidelines. On site experience: signed off on all types of visits; PSSV, SIV, IMV, COV. Experience of Observation/Training visit on all types of visits. Experienced at independent drug accountability and evidence of proactive identification / escalation / resolution of any issues found. Experienced at independent investigator site file review and evidence of proactive identification / escalation / resolution of any issues found. Off-site experience: mastery of basic category and familiarity with complex category of Clinical Monitoring Associate tasks. Comfortable in navigation within, and able to assist junior staff in: CTMS systems, Data Platforms for assigned projects, Microsoft Suite: Excel, Word, Power Point, Outlook, Site EMR systems. Model consistent professional maturity as represented by: Approaching mastery of professional communication in interpersonal and written work. Demonstrating conflict management skills such that the CRA is able to navigate challenging site relationships successfully. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Ability to cultivate strong relationships and establish credibility to influence others in situations without direct authority. Has good knowledge of Strategic Data Monitoring.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.