Worldwide Clinical Trials logo
Worldwide Clinical Trials

As a leading full-service global CRO, we work to create solutions that advance new treatments from discovery to reality.

Senior Clinical Research Associate – Rare CNS

Research AnalystResearch AnalystFull TimeRemoteSeniorTeam 1,001-5,000H1B SponsorCompany SiteLinkedIn

Location

Maryland

Posted

2 days ago

Salary

$97K - $193K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Senior Clinical Research Associate – Rare CNS

Worldwide Clinical Trials

• 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 • Perform various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets • Train the sites to collect data properly and report any potential safety-related events • Manage the site's activities during study maintenance and close down research activities at the sites once the study has concluded

Job Requirements

  • 5+ years of experience as a Clinical Research Associate
  • 4-year university degree OR Nursing Degree
  • Experience in Rare CNS is required
  • Proficiency in Microsoft Office, CTMS, and EDC Systems
  • Excellent interpersonal, oral, and written communication skills in English
  • Superior organizational skills with attention to detail
  • Ability to work with little or no supervision
  • Willingness to travel regionally required

Benefits

  • Competitive benefits package depending on location
  • Pay equity and transparency
  • Professional development opportunities

Related Categories

Related Job Pages

More Research Analyst Jobs

Cengage Group logo

Principal Business Analyst

Cengage Group

We are a global education technology company equipping learners with the skills and competencies needed to be job ready.

Full TimeRemoteTeam 5,001-10,000H1B No Sponsor

Role Description Are you eager to influence the information technology landscape in a significant way? Join Cengage, a top innovator in the field, and apply your expertise within a lively and collaborative workplace. We are in search of an exceptionally skilled Principal Business Analyst to join us. If driving flawless business solutions and integrating technology effortlessly excites you, this is the opportunity you have been seeking! In the role of Principal Business Analyst at Cengage, you will: - Lead and work alongside cross-functional groups to collect and examine sophisticated business requirements for Cengage's Salesforce Sales & Service Cloud platforms. - Conduct comprehensive business process analysis and meticulously document requirements. - Work alongside engineering teams to develop and effectively implement innovative and world-class solutions to support Salesforce CRM technology. - Provide expert-level support and training to business leads, ensuring they effectively apply the system and can drive adoption with their teams. - Evaluate and recommend new features and functionalities to enhance business processes. - Perform detailed testing and validation of configurations to meet business needs and industry standards. Qualifications - A minimum of 10 years working with Salesforce CRM technologies, including Salesforce Sales & Service Cloud platforms. - Proven background as a senior-level Business Analyst or a comparable position in the IT field. - Extensive system-level knowledge with the capacity to work independently. - Demonstrable experience working in sophisticated Salesforce environments supporting multiple selling models and business processes throughout the order-to-cash and customer service lifecycle. - Strong analytical skills with the ability to convert complex business needs into technical solutions. - Outstanding problem-solving abilities and a strict attention to detail. - Superb communication and interpersonal skills to foster collaboration across teams. - Relevant certifications are a plus. Benefits - Working with a world-class team on ambitious projects that drive real impact. - Opportunities for professional growth and development. - A culture that promotes work-life balance and flexible working arrangements. - Competitive compensation and comprehensive benefits package. - The chance to be part of a company that strictly adheres to ethical practices and values diversity. How to Apply If you satisfy the qualifications and have a strong interest in this opportunity, we encourage you to submit your application! Please include your resume and a brief cover letter that outlines your relevant experience and why you would be a great fit for this position. Company Description Cengage, a global education technology company serving millions of learners, provides affordable, quality digital products and services that equip students with the skills and competencies needed to be job ready. For more than 100 years, we have enabled the power and joy of learning with trusted, engaging content, and now, integrated digital platforms. We serve the higher education, workforce skills, secondary education, English language teaching and research markets worldwide.

United States
$101.9K - $163K / year
Full TimeRemoteTeam 10,001+H1B Sponsor

Role Description The Sr Business Analyst supports product teams by translating business needs and product priorities into detailed, actionable requirements and execution plans. Partnering closely with the Product Manager, this role refines and manages the product backlog, supports prioritization, and ensures delivery aligns with intended business outcomes. The Business Analyst may execute delegated Product Manager activities when capacity or capability constraints exist and play a key role in validating delivered functionality, tracking outcomes, and supporting product execution. Essential Functions and Responsibilities - Partners with Product Managers on backlog refinement and prioritization, including sequencing work based on value dependencies and capacity. - Defines the development-ready stories and requirements by breaking down epics and features into user stories, defines acceptance criteria, and documents high‑level non‑functional requirements. - Executes the delegated Product Managers’ responsibilities when the PM capacity or capability is limited, ensuring continuity of product execution. - Collaborates with development teams and Solution Architects to ensure stories are well understood and aligned with business outcomes. - Validates solutions aligned to the business units by participating in and supporting User Acceptance Testing to confirm delivered functionality meets defined requirements and acceptance criteria. - Measures visibility into delivery and outcomes by tracking and reporting on stakeholders to surface risks, dependencies, and performance insights. Additional Functions and Responsibilities - Tracks product budget usage and spend against plans. - Raises risks, budget concerns, and reallocation recommendations to Product Managers. - Supports sprint ceremonies by clarifying requirements and answering questions during delivery. - Supports product demos, walkthroughs, and stakeholder communications. - Serves as a subject matter resource for business workflows and operational processes. - Performs other duties as assigned. Qualifications - Bachelor’s degree in Business Administration, Information Systems, or a related field from an accredited college or university preferred. - Five (5) years of related experience or an equivalent combination of education and experience required. - Experience performing business analysis, requirements definition, or supporting product delivery required. - Experience in claims, insurance, healthcare, or other regulated operational environments preferred. - Experience working within agile or hybrid delivery teams preferred. Skills & Knowledge - Strong business analysis and requirements documentation skills. - Ability to translate business needs into detailed user stories and acceptance criteria. - Familiarity with agile delivery practices and backlog management. - Ability to assess scope, dependencies, and delivery complexity. - Strong analytical, problem‑solving, and organizational skills. - Experience tracking delivery metrics and supporting OKR reporting. - Ability to understand and communicate budget impacts and delivery trade‑offs. - Excellent verbal and written communication skills. - Strong cross‑functional collaboration and stakeholder management skills. - Ability to meet or exceed performance competencies. Work Environment - Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. - Physical: Computer keyboarding, travel as required. - Auditory/Visual: Hearing, vision and talking.

Indonesia
Mondelēz International logo

Business Analyst

Mondelēz International

We’re a house of incredible brands providing people with the right snack, for the right moment, made the right way.

Part TimeRemoteTeam 10,001+Since 2012H1B No Sponsor

Role Description You will be joining our Mondelez Digital Services (MDS) organization focusing on Legal and Corporate & Government Affairs (CGA) digital products. We are seeking an experienced Business Analyst to support the design, delivery, and evolution of a digital product within the MDS Legal and CGA domain. In this role you will work closely with our team and respective business stakeholders in the Legal and CGA functions, reporting into the Product Owner. You will be responsible for business requirements gathering, developing and supporting execution of our product strategy and roadmap for the MDS Legal & CGA products. This role requires a strong understanding of legal and CGA business processes and proactive stakeholder management, bridging the gap between business needs, privacy or cyber security requirements, and technical implementation. Qualifications - Professional maturity & good business acumen (prior CPG industry experience is a plus) paired with IT technical background - Experience in corporate environment supporting Legal and Compliance functions, with a focus on stakeholder management and application life cycle management - Min of 2 years of experience as a Business Analyst, or a similar role with experience in Agile Product Methodology (certification is a plus) - Good understanding of product ownership principles and practices - Working knowledge with Agile methodologies/tools (e.g. Scrum, Kanban, Jira) - Demonstrated experience in creating and executing IT delivery roadmaps in partnership with business stakeholders and business strategy - Demonstrated experience working in a team with colleagues and stakeholders across time zones in a global organization - Experience in IT solution/service delivery (ITIL certification is a plus) - Strong leadership and experience in vendor management and partnering with third party service providers - Fair understanding of cyber security and privacy requirements/regulations Requirements - Define, maintain, and collaborate on Vision and Strategy with respective business owners - Identify and prioritize opportunities to leverage AI solutions improving business outcomes - Connect global priorities and global owners with regional or business unit stakeholders and their local needs - Conduct research and stay current with the Legal & CGA tech market developments to inform product development and strategic decisions going forward - Collaborate with business stakeholders and their teams to understand their needs and translate them into detailed product requirements - Work closely with your Product Owner prioritizing & managing product improvements, roadmap and product backlog - Understand and translate business requirements into user stories that can be used for technical and architectural decisions - Manage the backlog and support test scenarios and define acceptance testing criteria - Effectively communicate product vision, strategy, and roadmap - Build strong relationships with business stakeholders, software vendors and 3rd parties - Build strong relationships with other MDS teams such as Architecture, O365, Network, Cyber Security - Facilitate cross-functional collaboration to ensure alignment and successful execution - Develop a deep understanding of our existing Legal & CGA systems - Provide business stakeholders with necessary IT support coordinating support requests with vendors or internal MDS teams (ITIL service mgmt. is a plus) - Manage contractual and financial matters (e.g. contract management & renewals jointly with procurement, annual budgeting, PO issuance, invoice tracking etc…) Benefits - The expected base salary range for this position is $102,600.00 to $128,250.00 CAD depending on several factors such as experience, skills, education, and budget. - This position is eligible to participate in a highly competitive bonus program with a target of 14% with the possibility for overachievement based on performance and company results. - Mondelez offers several generous employee benefits (some subsidized or fully paid for by the company), including health insurance, wellness and family support programs, life and disability insurance, retirement savings plans, paid leave programs, education related programs, and enhanced vacation and holiday entitlements. Company Description With several brands that are among consumer favourites, including Cadbury, OREO, Christie and Maynards, we are one of the largest snack companies in Canada. Many of our iconic brands are ranked first, second or third in their categories, and our manufacturers and pastry chefs have an enviable mission to create and manufacture chocolate, cookies, crackers and candy in our iconic factories and locations across Ontario. A company with many ambitious growth targets, we have invested close to $250 million in our Ontario plants in recent years alone; We run marketing campaigns promoting innovative products such as Cadbury Dark Milk tablets and OREO Birthday Cake and Peppermint Bark cookies. Our community of more than 2,683 employees is present across Canada and our head office is in Toronto. Passion and dedication characterize our Company. We encourage all our employees to be themselves at work, to speak out and to encourage diversity in all areas of activity. In addition, we foster a flexible work environment and place great importance on the notions of trust and empathy to promote a true sense of belonging.

Canada
C$102.6K - C$128.3K / year
Full TimeRemoteTeam 10,001+Since 1983H1B Sponsor

Role Description The Clinical Research Associate is responsible for the following: - Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Key Accountabilities: Site Management Responsibilities - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring activities in compliance with International Conference on Harmonization / Good Clinical Practices, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documents. - Gains an in-depth understanding of the study protocol and related procedures. - Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready. - Participates and provides inputs on site selection and validation activities. - Performs 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 validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner. - Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. - Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. - Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Manager and Partner Line Manager. - Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines. Team Development and Support - Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required. - Supports and/or leads audits/inspection activities as needed. - Performs co-monitoring visits where appropriate. Compliance with Parexel Standards - Complies with required training curriculum. - Completes timesheets accurately as required. - Submits expense reports as required. - Updates CV as required. - Maintains a working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. Qualifications - Fluent in local languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. - Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. - Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. - Hands on knowledge of Good Documentation Practices. - Proven skills in Site Management including management of site performance and patient recruitment. - Demonstrated high level of monitoring skill with independent professional judgement. - Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. - Ability to understand and analyze data/metrics and act appropriately. - Capable of managing complex issues, working solution-oriented manner. - Performs root cause analysis and implements preventative and corrective action. - Effective time management, organizational and interpersonal skills, conflict management, problem solving skills. - Able to work highly independently across multiple protocols, sites, and therapy areas. - High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. - Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. - Demonstrates commitment to Customer focus. - Works with high quality and compliance mindset. - Positive mindset, growth mindset, capable of working independently and being self-driven. - Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices. - Ability to travel domestically and internationally approximately 65%-75% of working time. - Current driver’s license required. Requirements - Minimum 2 years of direct site monitoring experience in bio/pharma/CRO. - Note: Specific monitoring and therapeutic area experience requirements may vary depending on the Country or study needs. Education - Bachelor’s degree preferred with a strong emphasis in science and/or biology. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

United States