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.
Assures compliance with local regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) and Good Clinical Practice (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.
Applies planning techniques for monitoring visits to ensure efficient and effective monitoring.
Plans and conducts study close-out visits for investigator sites.
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 anticipates/ identifies potential issues and implements corrective actions.
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.
Subject Rights & Wellbeing
Verifies 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.
Reporting and Tracking
Maintains site performance metrics with guidance and implements action plans for sites not meeting expectations with limited 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 Clinical Trial Management System (CTMS).
Maintains all areas of cover as assigned (site & study level) to audit readiness standards and supports preparation for audit and required follow up actions.
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).
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 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.
Performs IP inventory, reconciliation and reviews storage and security.
Verifies 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.
Documentation and Record keeping
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the trial master file (TMF).
Ensures investigator site is aware of requirement of archiving essential documents in accordance with the local guidelines and regulations.
Verifies site compliance with requirements for electronic data capture.
Maintains effective, accurate, and timely communication with site staff and project team, ensures appropriate issue escalation.
Seeks guidance to resolve more complex tasks.
Uses the appropriate mode of communication in relaying information.
Participates in global conference calls and meetings to review progress of ongoing clinical trials.
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
Attends clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements.
Maintains required functional and job specific training.
Performs other work-related duties as assigned.
As a representative of the Company, demonstrates professional attire, attitude and behavior in meetings & teleconferences, site visits and interactions, and interpersonal activities in general.
BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience.
Moderate experience as a CRA in directly relatable site management, or clinical site conduct experience.
Moderate understanding of SOPs, WIs, FDA and local regulations as well as ICH-GCP guidelines.
On site experience:
signed off to independently conduct at least two types of visits; PSSV, SIV, IMV, COV.
Experience of Observation/Training visit on all types of visits. Competent in independent drug accountability.
Competent in independent investigator site file review.
Demonstrates understanding of all Essential Documents and their collection and maintenance.
familiarity with basic category of Clinical Monitoring Associate tasks. Ability to understand/guide site staff to execute on clinical protocols.
Understanding of local regulatory, safety, and GCP. Demonstrate proficiency in navigation within: CTMS systems, Data Platforms for projects, Microsoft Suite: Excel, Word, Power Point, Outlook, Site EMR systems.
Model professional communication in both written and verbal interactions.
Demonstrate sufficient time management to achieve required deliverables.
Ability to handle multiple tasks to meet deadlines in a dynamic environment
Primary Location North America - US Home-Based
Job Clinical Operations
Travel Yes, 75 % of the Time
Employee Status Regular