Clinical Research Associate jobs

Work Schedule

Environmental Conditions

Job Description

Thermo Fisher Scientific’s Patient-Centered Research (PCR) group supports sponsors in incorporating the patient voice in all relevant healthcare decisions, from development over regulatory to reimbursement and product launch. The PCR group blends a unique combination of scientific fields, including health sciences, psychometrics, epidemiology, psychology, health economics and others. Our work has helped identify and clarify unmet clinical needs, assess burden of illness and evaluate patient outcomes, preference and/or adherence, while supporting promotional and labeling claims on a global scale. The advertised role will contribute to this research agenda and help ensure the patient voice is heard.

Overview:

The Research Associate III will support the delivery of patient-centered research work, which may include qualitative and quantitative clinical outcome studies (COA. The Research Associate would work in close collaboration with the Principal Investigator (PI), by leading scientific input from junior Research Associates and aligning with other functions (e.g., Project Management Office, Editorial Service, Data Collection Management & Analysis). The Research Associate will take up an essential role in planning, conducting, reporting and disseminating best-practice research. This includes applying quantitative methods to study design, COA evaluation, data analysis, and interpretation of findings. This is a client-facing role, and the successful candidate will have the opportunity to collaborate closely with a wide range of study sponsors across multiple indications and methodologies. This fast-paced and diverse role offers a wide range of opportunities to grow scientific knowledge and consulting skills.

Essential Functions

Research Activities

• Support the PI in the development of study designs, budgets and proposals, including quantitative and qualitative design considerations such as outcome selection, sample size, and analysis approach, as appropriate
• Develop deliverables ready for PI and client review (e.g., protocol, analysis plan, technical report)
• Coordinate and support junior staff throughout projects
• Communicate and manage internal and external stakeholders and vendors (e.g., vendors, patient advocacy groups, other departments)
• Conduct qualitative (interview) studies and/or surveys within or outside of a clinical trial setting to obtain feedback from participants (patient, caregiver, investigator ) on various topics i.e., understanding patients’ experience with their condition, its impacts on their lives, exploring treatment benefit, describing participant experiences, and identifying aspects of burden. For survey studies, contribute to development of the quantitative approach, including response options, scoring, and planned analyses, as appropriate.
• Work with the PI, client, and other project staff on the development, testing, and validation of fit-for-purpose clinical outcome assessments from a qualitative and quantitative perspective. Quantitative work may include evaluating measurement properties such as reliability, validity, responsiveness, and meaningful change.
• Manage qualitative and/or quantitative data analysis and data quality control, including appropriate descriptive and inferential analyses, review of analysis outputs, and interpretation of findings
• Contribute to scientific dissemination, where applicable (incl., manuscripts, posters, oral presentations at conferences)
• Contribute to research projects of the wider Patient-Centered Research (PCR) team, depending on capacity and availability
• undefinedTeamwork and QualityComplete relevant training courses on time (e.g., adverse event training, SOPs, ethics)Efficiently delegate and communicate with project teamsTake active responsibility for on-the-job learning of junior project team membersWork with the Project Management Office to track and drive the project timelines and budget useBe familiar with electronic filing requirements, relevant SOPs and IRB needsCommunicate effectively with clients Organizational ContributionsStay up to date with relevant researchContribute to initiatives in the Patient-Centered Research (PCR) team (e.g., budget-review committee, practical process improvements, contribution to training in the PCR University, serve as mentor to junior staff)Take part in team meetings and organizational discussionsRecord project time accurately at the end of each week

Qualifications:

• Education and Experience: PhD in relevant scientific discipline or master’s degree and at least three years of experience in relevant field or bachelor’s degree in a relevant scientific discipline and at least five years of experience in relevant field

Knowledge, Skills, and Abilities:

• Outstanding analytical and problem-solving skills, including the ability to assess quantitative data and draw appropriate conclusionsExcellent communication and scientific writing skillsDemonstrated ability to proactively and independently drive research projectsAbility and willingness to delegate and prioritize Prior experience supporting patient-centered research studies (e.g., COA development and validation studies, ITR).Proficient in the use of MS Word, PowerPoint, and ExcelExperience in the analysis of quantitative and/or qualitative data desirable, with experience in quantitative analysis particularly relevant to this roleFamiliarity with statistical methods used in patient-centered research, clinical outcomes research, or COA evaluationExperience with PubMed, or similar literature databases, advantageous.roughs.