OncoBay Clinical is a full service CRO focusing on complex oncology indications including Immunotherapy and cellular therapies. We know that innovative research requires innovative operations and build that into our culture, systems and processes. Our culture values and rewards critical thinking and open dialogue about quality — and that goes far beyond sole reliance on tools and checklists. We have an infrastructure to enhance access to patients, and integrated technology to provide higher quality and faster access to results. We remain vigilant and consistent with the advice in FDA Guidance on Monitoring, which encourages a quality risk management approach to clinical trial design and operation, and discourages a one size fits all mentality.
Are you ready to think outside the box and drive results? OncoBay Clinical might be the next right step to build your career and to make a difference.
JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Primary liaison for project site personnel throughout the study lifecycle from site identification through close out, including site identification and site start-up support.
- Performs site evaluation, site initiation, interim monitoring, and close-out assessments (performed on-site or remotely), telephone assessments and central monitoring (performed remotely), and site management, ensuring regulatory, ICH-GCP, and protocol compliance.
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH-GCP Guidelines or other applicable guidance, relevant regulations, and company processes.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each patient as appropriate.
- Assesses factors that might affect patient safety and clinical data integrity at a site such as protocol deviations and pharmacovigilance issues.
- In accordance with the CMP, assesses site processes and facilities, conducts Source Document Review and Source Document Verification, applies query resolution techniques remotely and on site, performs investigational product (IP) accountability, and reviews the Investigator Site File (ISF) and reconciles with the Trial Master File (TMF).
- Documents activities via confirmation letters, follow-up letters, site assessment reports, communication logs, and other required project documents as per SOPs and the CMP. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
- Routinely reviews clinical systems, dashboards, and documentation to oversee site conduct and identify any risks to delivery or quality. May be assigned to oversee study team conduct, including Site Assessment Report review.
- Reviews study and site data listings and visualizations via analytical dashboards and/or reports to identify trends, risks, suspected scientific misconduct on other systematic errors that could impact data integrity and subject safety.
- Provides support to the Project Manager to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
- Collects essential documents from the site and reviews and compiles essential document packages for site activation. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
- Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules.
- Provides support to the Project Manager to agree on country template contract and budget. Produces site-specific contracts from country template. Provide support in submissions for proposed contract and budget for site. Provides support in negotiating budget and contract with site via Legal and the Project Manager with Sponsor until resolution of issues and contract execution. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
- Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities and communication to ensure project objectives, deliverables and timelines are met.
- Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- As required, collaborate, and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff.
- Identify and communicate out of scope activities, operational efficiencies, and process improvements to the Project Manager.
- Develop country level informed consent forms.
- Participate in bid defense meetings as required.
- May lead other CRAs to ensure quality of clinical monitoring and site management deliverables.
- May be accountable for the clinical team’s understanding, ongoing compliance, and delivery according to the stated monitoring strategy, CMP, and risk plans.
- May review the content and quality of site monitoring documentation to ensure they represent site management activities and conduct.
- May evaluate CRA competency to perform site assessments independently via sign-off visits according to company standards and process.
Location: Tampa, FloridaApply