Job Location : 541 Church at North Hills St., Suite 1000, Raleigh, NC 27609. Position may telecommute from anywhere in the US up to 5 days per week.

Job Title : Consultant, Clinical Outcomes Assessment

Duties: Parexel International LLC seeks a Consultant, Clinical Outcomes Assessment reporting to headquarters in Raleigh, North Carolina to develop and lead clinical outcomes assessments (COAs) under limited supervision (10%). Act as a project lead and technical subject matter expert (SME) for Global Clinical Outcomes Assessment studies and RWE studies, including instrument development and validation, and burden of condition and treatment assessment (10%). Lead the design and implementation of cognitive debriefing and concept elicitation in-trial interviews, direct to patients and clinical experts' surveys, and ePRO implementation for Phase 2-4 trials (15%). Serve as SME for the development of study materials, including study protocols, informed consent forms, recruitment materials, interview guides, qualitative analysis plans, and codebooks for ethic submissions (20%). Lead coding, analysis, and reporting for qualitative interviews, including content validation and exit interviews (5%). Utilize software for data analysis and interpretation, including Atlas.ti, nVivo, and MAXQDA (5%). Guide study report development to summarize study overviews and convey and interpret study findings and conclusions (10%). Conduct quality checking processes of study materials, reports, and presentations (3%). Support psychometric evaluations of COA instruments to assess validity, reliability, and responsiveness (2%). Adhere to FDA, EMA, and other relevant guidelines for COA implementation in clinical research (3%). Author publications for conferences and in peer-review journals (2%). Identify new project opportunities for business development and develop proposals (8%). Act in a client facing role and in bid defense meetings to win new business (5%). Coach and mentor junior staff and administer subject matter training (2%). Telecommuting permitted from anywhere in the United States 5 days per week. (Ref. # 000990). Annual salary: $119,440 to $179,160.

Requirements: Master's degree in Public Health, Biology, or a related field plus at least three years of clinical outcomes assessment experience. Must have at least three years of experience in each of the following: 1. Utilizing software including Atlas.ti and nVivo; 2. Delivery of qualitative clinical outcomes assessment validation projects for pharmaceutical study sponsors; 3. Designing and implementing cognitive debriefing and concept elicitation in-trial interviews, direct to patients and clinical experts' surveys, and ePRO implementation for Phase 2-4 trials; 4. Conducting coding, analysis, and reporting for qualitative interviews, including content validation and exit interviews; 5. Delivery of COA strategy for Phase 2-4/RWE studies; and 6. ePRO implementation regulatory requirements in clinical research.

To apply, please send resume to [redacted] and cite requisition number 000990 or apply at jobs.parexel.com. This position is subject to the company's Employee Referral Program.