Kelly Services
Location
Modesto, CA | United States
Job description
Kelly® Science & Clinical is seeking a Clinical Research Site Manager for a full-time, direct-hire position with a research site in Modesto, ID. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Manager - Research Site Operations
The site manager oversees all direct reports including study coordinators and other site staff. This is a key position in the success of the organization. The site manager understands how to apply knowledge of managing internal and external people and organizations, coordinating and understanding how to manage workload and business need. These responsibilities include delegating studies, conducting and verifying all training is complete and documented, maintenance of accurate regulatory reporting and records, CTMS verification and coordination, study visit QA and monitoring, and working in collaboration with the Principal Investigator and leadership team to ensure enroll goals are met.
Principal Duties and Responsibilities
Site/Study Management
Continues mastery of Lead Clinical Research Coordinator principal duties and responsibilities
Display initiative and critical thinking in decision making around staff issues, recruitment, and site efficiencies
Delegates studies to appropriate staff as they are awarded
Liaises communication with PI’s, clinic staff, sponsor, sponsor representatives and vendors
Participates and presents at meetings with internal and external representatives as needed
Exhibits professionalism and appropriate experience with written communication
Provides leadership, coaching and development, and empowerment to all direct reports, maintaining an engaging a productive workforce, partnering with HR as needed.
Manages staff including but not limited to, interviewing, onboarding, staff coverage, performance reviews, time and attendance, team meetings, disciplinary action and terminations
Interprets and recommends changes to operational procedures as needed, and implements, and actively supports company processes and policies
Maintains a state of audit-readiness
Manages site level quality review, ensuring accuracy and completeness
Receives objectives and determine how to use resources to meet schedules and goals
Oversee timely start-up and ongoing site regulatory affairs
Oversee IRB and IB continuing reviews and audits
Coordinate storing of old study records per sponsor and GCP guidelines
Oversee the training and implementation of SOP’s and WPG’s at your site
Ensures research project enrollment goals are met according to project timeline
Other duties as assigned
Pipeline Maintenance
Maintains the overall study pipeline for the site and reports numbers and changes to Head of Clinical Operations
Works in tandem PI to complete FQs and CDAs in a timely manner
Coordinates and conducts pre-study site visits
Financial Management
Manages and contains site expenses to ensure financial objectives are met
Reviews study specific site budgets, providing constructive feedback as needed
Communicates site and study needs for accurate budget negotiations and amendments
Provides resource planning for office and facility-related research
Assists in assessing site profit and loss (P&L) reports and re-directing staff tasks to ensure financial performance targets are met
Ensure visits are completed in Clinical Conductor in a timely manner to ensure accurate accounting
Ensure timely and accurate expense reporting to finance dept
Patient Recruitment and Advertising
Review advertising budgets, set strategy, and implement best practices
Communicate often and effectively with CRO/Sponsor to ensure maximum support with enrollment
Oversee and maintain an up-to-date patient database within Clinical Conductor
Oversee creation and maintenance of prescreening questionnaires
Qualifications/Skills
Minimum of 3+ years of clinic research experience
Minimum of 2+ years supervisory experience, project/program management experience or direct management preferred, preferably at the site or CRO level
Experience in conducting, managing, monitoring, and/or analyzing clinical research projects
Experience using a Clinical Trials Management System preferred. Demonstrated knowledge of Good Clinical Practice and ICH, and other site-specific regulations
Excellent interpersonal, verbal and written communication skills, attention to detail, organizational and prioritizing skills, and time management skills required
Proficient with PCs and Microsoft Office applications
Experience with company representation and presentation at industry events such as MAGI, ACRP, ASN, and Site conferences etc.
Supervision
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Job tags
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