Description
PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship. For immediate consideration, please (1) apply and (2) email your resume directly to: Regan.Brown@KellyScientific.com.
Kelly® Science & Clinical is seeking a Site Manager for a direct hire position at a leading client in Wichita, KS. 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.
Pay Rate:
~$85,000/Year (commensurate with experience)
Overview:
The Site Manager is responsible for effectively managing day-to-day site activities for optimization of site performance. The Site Manager is responsible for driving the site to achieve company goals. Our clients are twofold, the sponsor and the participant. The Site Manager is responsible for ensuring contractual obligations are met and work is completed in a manner that leads to client satisfaction. It is the responsibility of the Site Manage to work with Company Leaders to problem solve issues that may arise that interfere with achieving company goals. It is imperative to represent himself/herself and the site in the most professional, ethical and positive manner. Reports to: Regional Director.
Schedule:
• Monday – Friday, 1st/Day: Standard Hours
Responsibilities:
Operational Planning:
• Review and discuss awarded studies with the Principal Investigator to assist Company Leaders in making informed decisions about what studies to conduct.
• Work with Company Leaders to make informed decisions regarding new staff needs for successful study conduct.
• Work with Company Leaders to ensure site has proper space, staff, and time to optimize study conduct, particularly participant recruitment and retention.
Clinic Operations Management:
• Work closely with Company Leaders regarding staff management.
• Demonstrate knowledge of research, Company expectations, and industry standards.
• Lead staff in continued growth and excellent performance.
• Hire quality candidates for positions within the site.
• Ensure site staff is qualified and trained for roles and duties.
• Work with Company Leaders to plan for upcoming studies.
• Ensure site staff and investigators are apprised of awarded studies.
• Monitor staff performance, holding staff accountable to expectations of role.
• Ensures staff complies with study protocols, FDA regulations, and ICH guidelines.
• Ensures staff complies with SOPs and other Tekton policies and processes.
• Monitor site quality and performance and develop solutions to optimize performance.
• Monitor study needs and assist staff with study conduct and management, as needed.
• Manage staff schedules for optimization of site performance.
• Provides performance feedback to staff.
• Work with Company Leaders to manage discipline, as necessary, HR issues, such as misconduct, violations of company policy, office turmoil, etc. of coordinating staff.
• Ensure staff compliance with company Employee Handbook.
Investigator Relationship:
• Works with Company Leaders.
• Develop strong working relationships with Investigators.
• Ensure Investigator coverage for optimal site visits.
• Collaborate with investigator to ensure study success.
Quality Control:
• Manage site quality control process.
• Monitors adherence to SOPs and takes immediate corrective actions as necessary to ensure compliance.
• Monitors site staff to ensure highest quality performance and adherence to Good Clinical Practice and FDA Regulations and guidance's. Takes immediate corrective actions as necessary to ensure compliance.
General:
• Serves as team member of Company.
• Communicate effectively and professionally with other team members in a timely manner.
• Represent Company in a professional manner.
• Promote harmony and professionalism within the workplace.
• Acquire and maintain the following Company training: Company Research, Inc. SOPs, processes, and policies – every year or as changes are made.
• Good Clinical Practice (GCP) – every 2 years.
• IATA Shipment of Hazardous Goods – (if applicable) every 3 years, or as directed.
• Participate in study-specific training as required.
• Maintain medical license(s), certifications, etc.
Study Coordinating & Recruitment (The following is listed for what is expected of site staff. This is listed here for sites where site managers are coordinating studies.):
• Ensure site is prepared for study conduct.
• Ensures appropriate staff attends Investigator meeting and Site Initiation Visit.
• Ensure staff who will be participating on the trial are trained appropriately.
• Ensure source creation is completed and reviewed in a timely manner.
• Work with Regulatory Staff to manage essential documents.
• Complete site level Regulatory duties, including continuing reviews and study close outs.
• Disseminate information to other personnel, as well as to potential patients.
• Ensure all staff is trained according to tasks that will be delegated.
• Ensure site has obtained all required documents and equipment to conduct study.
• Ensure site has received sponsor and IRB approval.
• Communicate with the sponsor in a timely manner.
• Communicate with others involved with/in the study, such as vendors, recruiting department and other resources as needed.
• Ensure recruitment goals for all studies are met or exceed.
• Ensure all study-related activities are completed per protocol. FDA regulations, ICH guidelines, and Company expectations.
• Ensure information is entered into case report forms completely and accurately.
• Develop relationships and communicate with sponsors and sponsor monitors.
• Ensure data queries are completed efficiently.
• Ensure study documents are complete, current and filed correctly.
• Ensure laboratory procedures are completed accurately.
• Manage study supplies o Ensure study closeout activities are completed efficiently.
Other duties as assigned.
Qualifications:
Required Skills/Abilities:
• Must be able to communicate in verbal and written form effectively.
• Must be able to read or learn to read scientific language and generalize information.
• Must be willing and able to adhere to instructions and regulations.
• Must demonstrate leadership skills.
Education & Experience:
• 3+ years' experience in the Clinical Research Industry.
• Supervisory/management experience or demonstrated definitive leadership skills.
• Experience with regulatory processes, clinical procedures, sponsor interaction, and human resources preferred.
• College or Specialized Degree preferred.
Physical Requirements:
• Must be able to work remotely and be available during business hours.
• Must be able to lift up to 15 pounds at times.
• Must be able to commute between sites in areas with multiple locations.
• Must be available to travel as needed (<20%).
What Happens Next:
Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry – even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
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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.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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