In clinical research feasibility is often what determines whether a study succeeds or fails. Your insights will directly influence how trials are set up how quickly they recruit and how successful they are in meeting their goals. This is a high-impact strategic role for someone who enjoys writing deep analysis and cross-functional communications.
- Analytical Work:
- Reviews scientific literature training and potential study materials pertinent to feasibility activities
- Responsible for final written feasibility and enrollment strategy and risk mitigation plan for assigned projects and presentation thereof to Sponsor
- Coordinates cross-functional execution of all feasibility services required for assigned projects and standalone feasibility studies
- Discusses key study elements through questionnaires and Investigator/ KOL interviews
- Conducts data mining of internal and external databases to recommend operational strategy (optimal site profile country/ site mix timelines and enrollment rates) during proposal through site selection stage
- Evaluates and recommends sites/ investigators for consideration in future clinical studies based on enrollment capabilities and metrics
- Participates in scientific conferences meetings symposia etc. to collect information on potential sites/ investigators and obtain in-depth training in the field of the meeting
- Assesses patient enrollment challenges and opportunities in ongoing and completed studies to improve patient recruitment and retention strategies
- Information and Communication:
- Liaises with other PSI departments to collate operational feedback and further support feasibility assessments
- Liaises with Project Management to evaluate the impact of feasibility results on patient enrollment metrics for awarded studies
- Primary point-of-contact for Business Development and proposal team for assigned feasibility assessments
- Collaborates with Study Startup to identify and illustrate the value-add of prioritized site relationships and accelerated startup timelines
- Quality Control & Assurance:
- Ensures adherence to the PSI/Clients procedures in all activities pertinent to feasibility research
- Develops and maintains company Quality System Documents (QSDs) pertinent to Feasibility Department
- Implements the Quality Control (QC) program aimed at assuring high standards of feasibility research and patient recruitment at PSI
Qualifications :
- Bachelors degree required
- Minimum of 5 years of experience in clinical research
- At least 2 years of experience in feasibility or patient recruitment
- Solid understanding of clinical trial protocol design and familiarity with varying enrollment strategies
- CRO experience strongly preferred
- Strong critical thinking skills with a proactive problem-solving mindset; able to work independently and take initiative in areas requiring interpretation and discovery
- Proven ability to thrive in a highly collaborative fast-paced team environment; a team-first mindset is essential
- Excellent written and verbal communication skills with the ability to clearly articulate scientific and operational concepts across cross-functional teams
- Advanced proficiency in Microsoft Office applications including Word Excel Outlook and PowerPoint
Additional Information :
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people then PSI is the right choice for you. You will be part of a collaborative Feasibility team.
For this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
Remote Work :
Yes
Employment Type :
Full-time