Research Analyst

• Conduct selection, initiation, monitoring, and close-out visits in line with GCP and ICH guidelines.
• Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.
• Provide protocol and study training to sites, maintaining regular communication to manage expectations and address issues.
• Assess site practices for protocol adherence and regulatory compliance, escalating quality issues as needed.
• Oversee regulatory submissions, recruitment, enrollment, CRF completion, and data query resolution.
• Ensure all site documents are filed in the Trial Master File (TMF) and Investigator’s Site File (ISF) per GCP/ICH and local regulations.
• Generate visit reports, follow-up letters, and other necessary documentation.
• Mentor clinical staff through co-monitoring and training visits.
• Work closely with study team members to support project execution.

Senior Clinical Research Associate, Oncology

• 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 and reporting potential safety-related events
• Collaborate with top-tier colleagues from various backgrounds and specialties

Senior Clinical Research Associate – Oncology

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites
• Conduct pre-study and initiation visits
• Ensure informed consent procedures and protocol requirements are adhered to
• Monitor data for missing or implausible data
• Complete Serious Adverse Event (SAE) reporting
• Assist with training of new employees

Clinical Research Associate II, Phase I

• Coordinates and conducts GCP and study protocol training at study sites and assures training is documented
• Builds rapport with study site staff to assure compliance with the protocol, applicable regulatory and guidance documents, SOPs, and all study activities
• Assists in reviewing the study records and all study notebooks to ensure contents are current and complete
• Assists in providing tracking and Quality Control (QC) of data as required and assists with responses to QA audits
• Evaluates Investigators and assists with selection of appropriate sites to conduct clinical studies
• Collaborates with the study Project Manager to assure study sites selected meet the needs of the study protocol
• Monitors assigned study sites through review of electronic data capture (EDC) systems, faxed, emailed, and paper documentation
• Serves as the liaison between Argenta US Clinical and study site personnel
• Facilitates clarifications, corrections, and data query resolution with study sites or data management personnel
• Tracks adverse events (AE’s) encountered in clinical studies and ensures all serious AEs and non-serious AEs are documented and communicated appropriately to the Project Manager and Sponsor
• Learns to assist with facilitates clarifications, corrections, and data query resolution with study sites or data management personnel
• Builds relationships with key individuals and contributors in the organization and beyond

Animal Health Clinical Research Associate III

• Research criminal records in jurisdictions throughout the United States
• Report results according to Validity's formatting standards
• Ensure compliance with the Fair Credit Reporting Act
• Compile information from various research sources
• Follow local, state, and federal laws in reporting records
• Liaise with the Quality Assurance team

Research Specialist – Full-Time

• 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

• Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Collaborate and liaise with study team members for project execution support as appropriate
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Clinical Research Associate – Sponsor Dedicated

• 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

• Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

• Closely monitor the office, industrial, flex, and life science commercial real estate market, including data related to properties, leases, sales, tenants, availabilities, and development.
• Develop comprehensive expertise in the local economy, including understanding the composition of jobs and industries, demographics, and the growth of companies within the market.
• Communicate data excellence and insights via traditional reporting products and the use of advanced data visualization tools, including JLL’s proprietary technology.
• Actively contribute to JLL’s internal data management system and adopt or discover new creative uses for its content and visualization tools.
• Publish quarterly market reports on the office and industrial sectors in assigned market(s).
• Contribute to client presentations by covering market intelligence, trends, and statistics.
• Develop strong relationships with internal and external clients and facilitate the use of research as a differentiator including being personally client-facing and externally focused on new business efforts.
• Keep track and inform brokerage leaders of local and national commercial real estate news.

• Engage in extensive training with senior Clinical Research Associates and Managers
• Conduct clinical monitoring visits in accordance with study protocol and regulations
• Suggest ideas to improve site recruitment plans
• Create and maintain appropriate documentation regarding site management
• Manage the progress of assigned studies by tracking regulatory submissions and approvals

Clinical Research Associate I

• Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work
• Work with sites to adapt, drive, and track subject recruitment plans
• Administer protocol and related study training to assigned sites
• Evaluate the quality and integrity of study site practices
• Manage the progress of assigned studies by tracking regulatory submissions and approvals
• Ensure copies/originals (as required) site documents are available for filing
• Create and maintain appropriate documentation regarding site management
• Collaborate and liaise with study team members for project execution support

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process
• Collaborating with investigators and site staff to facilitate smooth study conduct
• Performing data review and resolution of queries to maintain high-quality clinical data
• Contributing to the preparation and review of study documentation, including protocols and clinical study reports

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