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Form of workJob Description
Description:
Duties include:
Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.
Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions.
Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.
Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance.
Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional
Review Board renewals are completed.
Skills:
Clinical trial, Patient recruitment, IRB, GCP, EDC, Clinical research, Regulatory
Additional Skills & Qualifications:
Clinical research certification from ACRP, SOCRA, or Stanford's CROP
Bachelor’s degree in Clinical Research/Public Health/ Business or related field
2 years experience in project management and Clinical Research projects
Excellent communication skills
Excellent speaking and writing skills
Demonstrated ability to write manuals and procedural documents
Demonstrated ability to give presentations to stakeholders
Knowledge of Clinical Research Study Startup processes including IRB submissions, site feasibility analyses
Experience developing budgets
Experience supervising, training, and/or mentoring new staff or students
Strong leadership skills necessary for determining, recommending, and implementing improvements to policies/processes and best practices
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor’s degree in a related field and two years of experience in Clinical Research, or an equivalent combination of education and relevant experience.
Experience Level:
Intermediate Level
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About ActalentActalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
