Clinical Research Associate – Oncology

Research AnalystResearch AnalystFull TimeRemoteMid LevelTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

District Of Columbia + 7 moreAll locations: District Of Columbia | Florida | Ohio | Maryland | Pennsylvania | Tennessee | Texas | Virginia

Posted

19 hours ago

Salary

0

Seniority

Mid Level

Bachelor Degree2 yrs expEnglishGoogle Cloud Platform

Job Description

Clinical Research Associate – Oncology

Parexel

• Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. • 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 • 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

Job Requirements

  • Minimum 2 years of direct on site monitoring experience in biotech/pharma/CRO organization
  • Oncology monitoring experience required
  • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & 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
  • Demonstrated high level of monitoring skill with independent professional judgement
  • Able to work highly independently across multiple protocols, sites, and therapy areas
  • Demonstrates commitment to Customer focus

Benefits

  • Health insurance
  • Professional development opportunities

Related Categories

Related Job Pages

More Research Analyst Jobs

Research Assistant

Public Health Management Corporation

Public Health Management Corporation serves the greater Philadelphia, Pennsylvania, region with direct services and partnerships designed to improve the health

Research Analyst20 hours ago

Research Assistant Job category: Research Assistant Requisition number: RESEA007083 Full-time Corp Philadelphia, PA 19102, USA Job details Description DEPARTMENT: Research & Evaluation Group ROLE TYPE: Full-Time APPLICATION INSTRUCTIONS: Please submit a resume and cover letter to apply. The required cover letter is not just a formality; it is an opportunity to both demonstrate strong writing and explain how your skills and experiences translate to the work of R&E Group and make you a good fit for this position. Applications without a cover letter will not be considered. JOB OVERVIEW: The Research and Evaluation Group at Public Health Management Corporation (R&E Group) is seeking a full-time Research Assistant to join its team. R&E Group conducts applied research and evaluation, including work on program efficacy, intervention effectiveness, and needs assessments. The right candidate will enjoy a fast-paced, collaborative, and dynamic work environment where there is an opportunity to contribute to multiple projects focused on public health, substance use and addictions, family strengthening and child wellbeing, and teaching/learning. The Research Assistant will report to a Senior Project Director and should be prepared to work on multiple evaluation and research projects, supporting data collection, analysis, and dissemination. We are currently hiring for projects focused on substance use treatment and tobacco cessation. Because our project mix is constantly in flux, there will be opportunities to work in numerous topic areas over time. Specific duties may include data cleaning and coding; data analysis; transcription of focus groups and interviews; infographic design; interviewing/data collection (if the primary collector is unavailable); literature reviews; and report writing. R&E Group is committed to creating a pathway for employees to further their careers and encouraging growth within the department and beyond. Professional development opportunities are available for all R&E Group employees. These may include but are not limited to: presentations at national and local conferences; participation in work-related seminars; and contributions to scholarly manuscripts for publication. We are an equal opportunity employer that holds diversity and inclusion as values central to our mission and essential for our success. For us, this means promoting diversity of thought, experience, and culture, and creating an environment where all are respected, empowered, and safe to express their unique perspectives. We are committed to fostering and embracing our multilayered diversity; we strive to ensure that all R&E Group staff members are equally valued for their contributions to our team. RESPONSIBILITIES: - Conduct routine data quality assurance activities and data cleaning using SPSS or R software. - Conduct data analysis as needed using SPSS and/or R software. - Document participant service engagement using PHMC’s proprietary service registry and maintain service tracking records. - Manage and prepare data from REDCap, PHMC's proprietary service registry, and other research data sources. - Assist with the preparation of progress reports, data requests, presentations, and manuscripts for publication. - Support grant and proposal development activities by assisting other team members with the submission of a minimum of four proposals per year. Proposal tasks may include but are not limited to: proposal task management; form completion; literature reviews; managing references and citations; drafting sections of proposal content; developing graphics and charts; and obtaining letters of support. - Engage with study participants, community members, and clients in a way that is inclusive, culturally responsive, and respectful of cultural differences. - Conduct internet research and literature reviews. - Conduct interviews and assist with focus group planning, facilitation, and transcription of qualitative interviews and focus groups. - Perform other research-related duties as assigned. SKILLS: Required - Excellent written and oral communication skills - Strong analytical, interpersonal, recordkeeping, organizational, and time management skills - Knowledge of primary and secondary data collection techniques - Proficiency with data analysis and graphics programs, including Excel and PowerPoint; experience with SPSS or R is required - Knowledge of basic descriptive and inferential statistics - Demonstrated initiative, including the ability to solve problems, learn new skills, take on new responsibilities, and proactively seek assistance when needed - Ability to manage multiple projects and competing deadlines in a fast-paced environment - Strong attention to detail and commitment to producing accurate, high-quality work - Commitment to fostering an inclusive, respectful, and collaborative work environment Preferred - ArcGIS experience - Advanced data visualization skills are not required but are a plus. Advanced skills might include technical proficiency in developing high-quality charts and the ability to select data visualization techniques appropriate for the data and audience. EDUCATION: - Bachelor’s degree in social sciences, public health, education, or a related field required EXPERIENCE: Required - 1+ years of experience with research data management systems (e.g., REDCap) - Experience in collecting, managing, and analyzing research data Preferred - Experience conducting data quality assurance and data cleaning - Experience supporting grant and proposal development activities - Experience working with service registry or electronic health record data - Experience conducting qualitative interviews and/or facilitating focus groups - Experience working with underserved communities COMPENSATION: - PHMC Pay Grade 16 - Salary is commensurate with experience. - PHMC offers a competitive benefits package that includes generous paid time off; multiple health insurance plan options; a 403(b) retirement plan with employer matching; flexible spending account options; an on-site fitness center; and more. Currently, full-time R&E team members are eligible to work remotely up to two days per week. PHMC is an Equal Opportunity and E-Verify Employer. Qualifications Skills Preferred Data Analysis Intermediate Attention to Detail Advanced Analytical Advanced Behaviours Preferred Team player: Works well as a member of a group Dedicated: Devoted to a task or purpose with loyalty or integrity Detail-oriented: Capable of carrying out a given task with all the details needed to get the task done well Education Required Bachelors or better in Social Science or related field.

Pennsylvania
Full TimeRemoteTeam 10,001+Since 2013H1B Sponsor

• Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. • Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials. • Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience. • Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects. • Responsible for activities as assigned by manager. • Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. • Generates and ensures effective recruitment and retention techniques/plans based on the patient disease journey. • Demonstrates ability to openly listen to and consider viewpoints to enhance outcomes. • Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. • Manages investigator payments as per executed contract obligations, as applicable.

North Carolina
$96.5K - $183.5K / year
ContractRemoteTeam 1,001-5,000Since 1972H1B No Sponsor

• Conducting interviews with key players along the value chain: manufacturers, suppliers, distributors, associations, government, etc. • Researching contacts / networking to establish links in the industry. • Reviewing and collecting information from secondary sources. • Visiting retail stores to gather product information and speak to staff. • Analyzing quantitative (MS-Excel) and qualitative information. • Hypothesis testing. • Generating MS-Word and PowerPoint reports in English. • Availability of min. 30 hours per week when actively engaged on a project

Angola
Full TimeRemoteTeam 1,001-5,000Since 1972H1B No Sponsor

Role Description This position is for self-employed contract/per project work in Angola. We would contact you when a project is available and fits your background, send you an offer to work in that specific project for a given period of time, and pay you after you complete all required deliverables. Euromonitor International is looking for a professional with a business background to support the fieldwork of our market research projects in Angola. You will be regularly engaged on short-term ad-hoc projects (approx. 6-8 weeks per project) as we require your skill set in the region, remotely supported on each project by a project manager in one of our EMEAI offices. This role will suit a self-starting and independent individual, who is looking for the flexibility of working from home. Experience within the FMCG/consumer service sectors is ideal. As part of Euromonitor’s core methodology, our analysts gather relevant information from in-depth conversations with key industry decision makers. Success relies on researchers’ ability to proactively recruit and secure interviews with the right contacts, and their ability to uncover key data and insights via open discussions. Being ad-hoc, our projects can address different types of questions to deliver insightful business intelligence. Examples of this include: - How much dairy was sold in Angola in 2018? Why did sales increase/decline over the previous year? - What companies are the leading players in the consumer finance market? What share of sales is held by the leading brands? - What are the ideal channels for meal kits in Angola? - Why is company X doing better than company Y? What strategy is being employed and how is this supported operationally? Qualifications - Fluency in English and the local language. - Previous experience working on a short-term contract basis or in a freelance capacity. - Proven proficiency with Microsoft Office (Word, PowerPoint, Excel). Requirements - Conducting interviews with key players along the value chain: manufacturers, suppliers, distributors, associations, government, etc. - Researching contacts/networking to establish links in the industry. - Reviewing and collecting information from secondary sources. - Visiting retail stores to gather product information and speak to staff. - Analyzing quantitative (MS-Excel) and qualitative information. - Hypothesis testing. - Generating MS-Word and PowerPoint reports in English. - Availability of min. 30 hours per week when actively engaged on a project. - Tenacity in the pursuit of information and a keen attention to detail. - Strong communication skills and a willingness to find strong industry contacts. - High level of numeracy - Ability to work with, analyze, and interpret data. - Excellent time-management, organization, and self-motivation skills. Benefits - Continuous training in our market research methodologies via online courses and selected live training sessions. - Collaboration with an international team across EMEA and beyond. - The ability to contribute to research projects for top multinationals. - The opportunity to develop and position yourself as a local market research expert. - Flexible hours from the comfort of your home.

Angola