Clinical Research

• Oversee the planning, initiation, execution, and closure of clinical trials within your region
• Ensure compliance with GCP, FDA, and other applicable regulatory requirements
• Manage site selection, initiation, monitoring, and closing activities
• Collaborate with cross-functional teams to ensure efficient and effective trial operations
• Monitor trial progress and troubleshoot issues that may arise, providing timely solutions
• Develop and maintain strong working relationships with investigative sites and teams

Freelance Regional Clinical Trial Manager

Research Analyst

• Collect, track and review investigational site records relating to subject screening and enrollment
• Assist in the development of study plans and status reports
• Collect, track, and review all site regulatory documents
• Assist with development and review of Informed Consent Forms
• Interact with sites, clients, vendors and internal study team members
• Maintain the clinical trials management system (CTMS) and other project tracking tools
• Track study supplies and coordinate shipments of supplies to sites as needed
• Manage the study Trial Master File (TMF) and ensure periodic TMF audits
• Coordinate work with CRAs monitoring on-site
• Perform on site co-monitoring and remote monitoring activities
• Perform regular reviews of data entered by investigational site staff according to data review/monitoring guidelines

In-House Clinical Research Associate

• May contribute to the development of study tools and materials as well as documentation for clinical trials
• May provide mentoring, training, and co-monitoring of junior CRAs and other clinical team members
• May provide support to the RFP process
• Prepare and perform all onsite & off-site/remote site monitoring visit activities across multiple protocols, inclusive of all study visit types as needed (SQV, SIV, IMV and COV), according to Good Clinical Practice (GCP), Protocol, applicable regulations and Sponsor requirements under supervision of experienced staff
• Effectively documents observations in site visit reports and follow up letters within timelines required by Rho’s procedural documents and the applicable clinical monitoring plan
• Prepare (if needed) and maintain Investigator Site Files (ISF), and maintain site binders and documents of the TMF (Trial Master
• May assist in payment processes, including liaison with Site and review Site and patient data for visits being invoiced
• Assist in the appropriate identification and action of AE (Adverse Event), SAEs (Serious Adverse Event) and pregnancy reporting procedure
• Verify and confirm appropriate IMP (Investigational Medicinal Product) handling at Site and perform drug accountability
• Help to plan and perform Country and Site Feasibility, including assessment of potential Risks and challenges, as well as select Study sites and perform pre-study visits
• Assist in selection of Study specific Vendors and perform Vendor assessments
• Support in negotiation and execution of Investigator/ Institution contracts
• May help to prepare documents submission to Ethics Committee, Competent Authorities and other bodies (as applicable), including communication with Sponsor, EC/ CA and other involved parties
• Provide mentoring, training, and co-monitoring of junior CRAs and other clinical team members.
• May support Clinical Team Lead and Project Management tasks on assigned studies as-requested (e.g. study specific process development, trip report review, newsletter creation, leading CRA project team calls, etc.)
• May conduct sign-off visits to assess competency of other CRAs
• May attend and present at meetings and conferences, including Investigator Meetings
• May participate in the interview and selection process for CRAs

Senior Clinical Research Associate

Clinical Operations

• Lead large, global, and/or complex clinical trial projects, conceptualizing the execution strategy for each component project
• Prepare project management plans and other governance documents
• Recommend and implement operational strategies as well as risk management plans
• Manage assigned project resources, including ensuring that project tasks are correctly assigned to staff and vendors
• Manage project and vendor budgets and scope of work, including recognizing and negotiating changes in scope
• Make tactical recommendations to customers to improve projects and provide strategic and tactical guidance to team members
• Mentor and provide training and orientation for team members
• Manage team dynamics and provide frequent feedback to team members
• Collaborate with customers to provide win/win solutions
• Contribute to business development initiatives, including proposals, responses to RFIs, and bid defense presentations

Senior Clinical Project Manager

• Develop, test, maintain, and archive SAS program code to conduct planned and exploratory statistical analysis of clinical data
• Interpret the results using written, oral, and graphic methods, as appropriate, either in a statistical report or as part of a clinical trial report
• Prepare analysis plans and specifications for analysis data sets and data displays (tables, listings, & graphs)
• Collaborate with statistical programming team on the production of datasets and displays
• Identify and troubleshoot missing, miscoded, or incomplete data and work with clinical team to resolve issues
• May perform sample size computations and develop/validate randomization schemes for clinical trials

Biostatistician I

• Join us in redefining what it means to work for a CRO.
• Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.
• You will play an integral to driving project success.
• You’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Rho Standard Operating Procedures.
• You’ll need proven monitoring skills in order to conduct site visits to assess site adherence to protocol and regulatory requirements as well as manage required documentation.
• You will also be responsible for ensuring the data remains audit ready and able to pass an audit by Rho, the Sponsor, or a regulatory agency.
• This position is a remote role to be located within a 1-hour commute of a US metropolitan airport with the commitment to conduct 8-10 site visits days per month (up to 80% travel).

Clinical Research Associate II / Senior CRA

QA Engineer

• Act as the primary administrator for NetSuite, Concur, FloQast and related financial systems working closely with other system administrators, business stakeholders, and Information Technology.
• Maintain user roles, profiles, permissions, and security settings.
• Manage integrations and data uploads between NetSuite, Concur, ADP, Certinia/Salesforce and other data warehouse systems.
• Monitor system performance, licensing and user capacity, troubleshoot issues, and coordination with IT and vendors as needed.
• Provides on-going systems and technical support as the primary contact for all requests and issues with internal customers and to Oracle and other vendors.
• Maintain a strong understanding of general ledger, AR, AP, revenue recognition, planning, audit scope and requirements, and reporting.
• Develop and maintain workflows, validation rules, and automations to improve operational efficiency including developing and creating applicable procedural documents.
• Partner with accounting, finance, FP&A and Transformation teams to translate business needs into system solutions.
• Oversee data quality, ensuring audit readiness.
• Build and maintain reports as needed.
• Provide user support and training for finance systems functionality, working closely with Employee Experience staff.
• Create and maintain documentation, process guides, and applicable procedure documentation and standard operating procedures.
• Act as a liaison between business stakeholders and technical teams to ensure consistent adoption.
• Stay current with all finance system updates and releases and recommend enhancements to functionality, making recommendations to the roadmap.
• Participate in system governance, change control and continuous improvement initiatives.
• Collaborate with internal stakeholders to plan and implement enhancements that support scalability and compliance.

Financial Systems Administrator – NetSuite, Concur, FloQast

Medical Director

• Serve as Medical Advisor on assigned projects.
• Provide medical support to investigative sites and project staff for protocol-related issues.
• Perform review and clarification of trial-related Adverse Events (AEs) and coding.
• Perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narratives.
• Perform medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
• Perform medical review of the Clinical Study Report (CSR), patient narratives, and other high-profile documents such as marketing application, clinical safety/efficacy summaries and overviews.
• Serve as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned projects.
• Participate in the development of Medical Monitoring portion of client proposals including the budgeting process.
• Support Business Development activities by reviewing and providing medical/scientific input and guidance on Requests for Proposals (RFP), as well as being an active participant and Rho representative at bid defense and other meetings with sponsors.
• Support Feasibility activities as required.

Medical Director – Senior Medical Director, Pain Experience

• Collect, track and review investigational site records relating to subject screening and enrollment.
• Assist in the development of study plans and status reports.
• Collect, track, and review all site regulatory documents.
• Assist with development and review of Informed Consent Forms.
• Interact with sites, clients, vendors and internal study team members.
• Maintain the clinical trials management system (CTMS) and other project tracking tools.
• Track study supplies and coordinate shipments of supplies to sites as needed.
• Manage the study Trial Master File (TMF) and ensure periodic TMF audits.
• Coordinate work with CRAs monitoring on-site.
• Perform on site co-monitoring and remote monitoring activities.
• Perform regular reviews of data entered by investigational site staff according to data review/monitoring guidelines.