Research Analyst

• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects
• Conduct study initiation visits (SIVs)
• Ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirements

Senior Clinical Research Associate – CNS/Psychiatry

• Conducting thorough research into an individuals’ background using a variety of tools, such as databases and public records
• Gathering information, analyzing data, and compiling this information to be entered into a final report
• Processing searches related to background screening reports
• Ensuring all searches are processed and reported according to state and federal laws as outlined in AccuSourceHR’s reporting guidelines
• Ensuring all searches are processed according to client guidelines
• Retrieving public records information and entering said information into our platform
• Analyzing information and comparing data sets to confirm matching identifiers
• Performing other duties as assigned
• Meeting or exceeding minimum standard service requirements

Research Specialist

• Provides high quality customer service to merchants by responding to inquiries regarding the support of Merchant Credit Card processing as well as other areas as assigned
• Responds to telephone inquiries, requests and problems from merchants
• Troubleshoots, diagnoses and provides merchants with solutions to resolve problems with service, authorization and credit card processing terminals
• Communicates applicable policies, procedures and practices to merchants
• Requests exceptions to policies and procedures on behalf of merchant as appropriate, within established limits

• Oversee the management and tracking of clinical trial data to ensure accuracy, integrity, and completeness.
• Conduct site qualification visits, site monitoring visits, and study close-out visits. Provide support to site staff during audits or inspections.
• Ensure clinical trials are conducted in compliance with protocols, Good Clinical Practice (GCP), ICH guidelines, SOPs, and regulatory standards (FDA/DEA).
• Review and manage electronic Case Report Forms (eCRFs), ensuring data is accurate and aligned with study protocols.
• Assist in the development and maintenance of Case Report Forms (CRFs) and other study-related documents.
• Provide training to site personnel on study procedures, protocols, and regulatory requirements.
• Regularly review data entered into the Electronic Data Capture (EDC) system to ensure compliance with study protocols.
• Identify, address, and escalate any study-related risks, issues, or opportunities for improvements.
• Follow up with clinical sites to ensure that data collection is progressing as planned and all required documentation is completed.
• Ensure timely and accurate management of regulatory documents and maintain compliance with regulatory requirements.
• Engage with Key Opinion Leaders (KOLs) in the medical and research communities to stay informed on scientific research and clinical data.
• Stay up-to-date with the latest developments in scientific research and clinical data relevant to Kuros Biosciences.
• Review and track clinical trial-related invoices, ensuring accuracy and compliance.
• Contribute to the creation and maintenance of project plans for clinical trials, ensuring alignment with company policies and timelines.
• Work independently to complete tasks while ensuring alignment with team objectives, timelines, and expectations.
• Expected to travel 3-5 days per month for site visits and clinical trial support.

Clinical Research Associate

• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects
• Involved in all stages of the clinical study, including identifying potential sites, performing study start-up activities, and supporting negotiation of contracts and budgets
• Training the sites to collect data properly and report any potential safety-related events
• Managing the site's activities during study maintenance and closing down research activities once the study has concluded
• Conduct study initiation visits (SIVs)

Senior Clinical Research Associate, CNS

• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gain in-depth understanding of the study protocol and related procedures.
• Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness.
• Participate & provide input on site selection and validation activities.
• Perform remote and on-site monitoring & oversight activities using various tools to ensure:
• Data generated at site are complete, accurate and unbiased
• Subjects’ right, safety and well-being are protected
• Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager.
• Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Supports audit/inspection activities as needed.
• Travel Requirements up to 75%.
• Adhere to all aspects of Ora’s quality system.
• Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.
• Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.

Clinical Research Associate II

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) 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 SOPs/processes
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate
• Demonstrates diligence in protecting the confidentiality of each subject/patient
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Assesses site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP)
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
• 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
• Verifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
• Verifies 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
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness
• Reconciles contents of the ISF with the Trial Master File (TMF)
• Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
• 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
• Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
• Must be able to quickly adapt to changing priorities to achieve goals / targets
• May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate
• 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
• Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
• May provide training or mentorship to more junior level CRAs
• May perform training and sign off visits for junior CRA staff, as assigned

See all jobs on JobTailor