Research Analyst

• 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

• Conduct in-depth due diligence on investment management firms and multi-asset strategies
• Lead and/or participate in manager interviews with portfolio management teams and business leadership
• Perform qualitative assessment of investment teams and organizations
• Build and maintain analytical content across research deliverables
• Produce high-quality written research
• Contribute to post-meeting discussions and the development of recommended manager ratings
• Attend external conferences, as appropriate
• Provide ad hoc support to consultants in preparing for internal and external research meetings

Investment Research Specialist

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities
• Assess investigational product through physical inventory and records review
• Documents observations in reports and letters in a timely manner using approved business writing standards
• Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution
• May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner
• Conducts monitoring tasks in accordance with the approved monitoring plan
• Participates in the investigator payment process
• Ensures a shared responsibility with other project team members on issues/findings resolution
• Investigates and follows-up on findings as applicable
• Participates in investigator meetings as necessary
• Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites
• Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted
• Performs trial close out and retrieval of trial materials
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations
• Conducts on-site file reviews as per project specifications
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required
• Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System)
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts
• Responds to company, client and applicable regulatory requirements/audits/inspections
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members
• Contributes to other project work and initiatives for process improvement, as required

Clinical Research Associate II – Oncology, Ophthalmology

• 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

• 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

• 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.

• Conduct Operational Due Diligence research on new and existing investment firms on GMR’s list
• Assist investment analysts in sourcing and adding strategies to GMR’s recommended list.
• Evaluate third party investment firms through an operational lens
• Draft communications to the field, including communications related to changes in money manager ratings, manager updates and topical white papers
• Perform risk analysis on third-party investment firms
• Cover a universe of third party investment firms, following GMR’s stated process.

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