The Senior Associate is integral in the management of patient-centric outcomes research in a fast-paced consulting environment. This research informs the development and validation of patient-centric measures used in pharmaceutical and bio-tech clinical development programs, regulatory filings, and reimbursement submissions. The Senior Associate manages various diverse research projects simultaneously related to patient-centered assessment including, but not limited to: performing literature reviews and gap analyses; conducting semi-structured qualitative interviews with patients and/or caregivers; coding and analyzing qualitative and quantitative data using best practices; leading the development of study protocols, their approval by Ethics Committees/Institutional Review Boards (IRBs), and technical study reports; reviewing all project deliverables to ensure scientific accuracy, quality and, assisting in overall day-to-day project management and ensuring timelines are met.
Key attributes include practical research implementation experience (IRB process, participant recruitment), strong research and critical thinking skills, as well as experience with conducting qualitative and quantitative research. Strong communication, scientific writing, and problem-solving skills are a must. Collaborative team member who can efficiently multi-task and demonstrates the ability to take initiative and get it done are core to the position.
Essential Functions include:
- Preparing project proposals, study protocols, technical reports and other client deliverables
- Conducts literature reviews, data extraction, and data synthesis
- Responsible for the accuracy and integrity of qualitative data collection (i.e. conducting patient interviews/focus groups) and analyses (preparing codebook and coding transcripts)
- Develops data collection tools and responsible for all aspects of data management
- Oversees and conducts site recruitment, management, and training
- Delegates appropriately and communicates proactively and regularly with study director and other team members
- Effective at tracking timelines and keep project team informed
- Maintains a working knowledge of current scientific literature and regulatory guidance related to patient-focused drug development and endpoint measurement
- Co-authors scientific conference presentations and manuscripts for scientific journals
Master's or PhD in research psychology, health services research, public health, epidemiology other relevant discipline required, along with 3+ years' work experience. Requires demonstrated experience conducting qualitative and quantitative research, familiarity with regulatory guidance for patient-focused drug development and at least 3 years experience working in a research setting.
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