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- Full/Partial ownership of the Feasibility/Site identification tasks in designated lead studies inclusive of but not limited to maintaining the site ID tools, running inconsistency checks, archiving emails at regular intervals.
- Provide support to Site selection lead for an oversight study by maintaining the site ID tools, CDA review, running inconsistency checks if agreed, archiving emails at regular intervals and extract bulk PDF using company software as previously agreed. Provide support to Site selection lead in their assigned tasks of site list development by performing inspection checks, past experience checks, Canada Opt in/out, Citeline data extraction as requested and setting up of site ID tracker.
- Create electronic surveys using company software not limited to study specific surveys and ad hoc electronic survey request. (E.g., Clinical Quality Control (CQC) visits, feedback, quiz, database of sites, Pre-screening logs etc.)
- Build scoring tool inclusive of Pre-Selection Visit or Risk Based Monitoring tool as needed.
- Engage is share drive cleaning at regular intervals.
- Independently run the automated dashboard as per schedule.
- Perform review of various tasks and provide feedback to site selection specialist inclusive of but not limited to electronic surveys, site ID tool builds, Inspection check and Citeline data extraction and provide feedback.
- Maintain master site list for allocated client/indication.
- Run and calculate Site ID monthly metrics every month using the trackers saved by site selection specialist.
- Lead, participate and review preparation of site selection curve/graph when streamlined.
- Review random Quickbase check clean up done by Site Selection Specialist.
- Responsible for setup and conduct for feasibility/site identification studies according to timeline and quality standards and client expectations.
- Conduct process related trainings to new team members joined as site selection specialist.
- Take on the mentorship role for new team members and report to line manager of progress.
- Learn and utilize the data sources available for site performance data.
- Plan and participate in internal planning meetings.
- Ensure accuracy and quality of survey data.
- Work with team and other Senior staff to identify potential risks and out of scope activity.
- Ensure site identification team in each country is entering and updating internal tracking tools for the studies assigned.
- Liaise with the global, cross-functional teams, inclusive of legal, start-up, clinical, country teams, and project management when needed.
- Support Investigator Intelligence database development and maintenance.
- Develop and deliver training of feasibility and site identification requirements/processes · Plan, lead and participate in the development, implementation, and maintenance of systems.
- And all other duties as needed or assigned.
- Qualified candidate has an Associate's degree with equivalent work experience or equivalent years' relevant work experience.
- Minimum of 4-5 years of full-time working experience, with minimum 1 year in the drug development or healthcare industry, working in some capacity with data related to investigators and/or clinical research institutions.
- Other required work-related experiences: Knowledge of ICH/GCP guidelines.
Senior Site Selection Specialist - Mumbai, India - Fortrea
Description
Description
:Qualifications (Minimum Required):
Experience (Minimum Required):
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.