Site Manager

Job Description:

• Supervise Clinical staff and the administration of clinical trials.
• Ability to supervise and train employees, including organizing, prioritizing, and scheduling work assignments.
• Site Manager oversees all members of the practice participating in clinical research.
• Strong understanding of financials and performance metrics.
• Excellent people skills and proven success leading and managing teams.
• Professional and highly motivated “self-starter” with the ability to exercise initiative
• Must have the ability to work as a team leader as well as independently while managing a variety of study related projects simultaneously.
• Ability to quickly adapt to working in a wide variety of dynamic therapeutic areas of medicine.
• Ability to multi-task and perform multiple critical tasks simultaneously (under dynamic and ever-changing circumstances).
• Strong written, verbal communication and interpersonal skills.
• Demonstrated ability to exercise standard universal precautions; in the alternative, the ability to quickly learn and apply Universal Precautions.
• Demonstrated ability to operate basic office equipment including (but not limited to) copy machines, facsimile machine, multi-line telephones and computers.
• Ability to be ambulatory most of the workday.
• Demonstrated ability to work with IRB submissions and correspondence.
• Comply with OSHA regulations.
• Ability to administer prescribed treatments according to protocol.
• Demonstrated excellence in performance of standard operating procedures.
• Critical thinking, analytical, mathematical skills.
• Regular and predictable attendance is an essential function.
• This position will be responsible for performing diverse managerial and administrative responsibilities requiring analysis, sound judgement, a high level of knowledge of study protocols and strong business management skills.
• To consistently embody KUR’s Core Values.
• Excellence and Consistency.
• Respect for our Subjects, Sponsors and Team Members.
• Manage all clinical research staff including investigators, coordinators, lab(s) & to ensure optimal performance on each study.
• Potential of managing the operations of one or more sites.
• Ensure all personnel obtain detailed knowledge of all components of study protocol through review of study and training, prior to the study effective date, to ensure protocol compliance.
• Review with the research team all components of the study prior to initiation date to ensure complete understanding and acceptance of roles and responsibilities during study.
• Provide direction and support to research team during subject screening to ensure qualified subjects are identified and enrolled in the study in a timely manner.
• Ensure the research team develops and implements an effective enrollment plan to ensure subject enrollment consistent with the sponsor’s protocol and enrollment period.
• In cooperation with the Principal Investigator, oversee all studies and ensure they are conducted according to FDA regulations, GCP guidelines and KUR’s SOP’s
• Participate in the process of managing sites/revenues for maximum site performance.
• Ensure accurate and complete drug/device distribution and accountability records of all investigational products that are maintained, and the product is stored according to requirements.
• Ensure prompt reporting of all adverse events to the principal investigator, sponsor, and IRB in compliance with FDA regulations and sponsor requirements.
• Ensure serious adverse events are reported by the Coordinators to the Principal Investigator immediately, the sponsor within 24 hours and the CRO and IRB promptly.
• Ensure case report forms are complete and accurate and maintained by Coordinators/Data Managers per FDA requirements, sponsor requirements and KUR’s SOP’s
• Ensure Vendor Assessments are completed for any vendor used that can affect the integrity of our data.
• Ensure all laboratory tests are performed at the designated lab facility completely, accurately, and according to established procedures and study protocol
• Meet and greet monitors during their visits.
• Implement all KUR SOPs, site manual procedures, and ensure regular compliance.
• Implement and monitor Key Performance Indicator (KPI) Metrics Development and Reporting.
• Ensure the research team provides sponsors with required information that is complete and accurate per research agreement.
• Inform sponsor, QA, Regulatory and VP of Compliance of prospective FDA audits and determine steps necessary to correct deficiencies identified in an FDA audit and implement changes.
• Full responsibility for developing the site team, including recruiting, interviewing, hiring, coaching, documenting, and administering progressive discipline process.
• Empower team members to take responsibility for their jobs and goals.
• Delegate responsibility and expect accountability and regular feedback.
• Hire, train, and develop new team members to meet organizational needs.
• Consciously create a workplace culture consistent with the overall organization's and that emphasizes the identified mission, vision, guiding principles, and values of the organization.
• Provide timely feedback on employee performance, helping to develop a team members skill where needed, and addressing performance problems.
• Coach, mentor, and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities.
• Coordinate and lead at staff meetings at least once per month.
• Lead and administer employee performance evaluations and provide feedback on areas of improvement.
• Create, lead, and motivate teams that achieve maximum site level performance
• Travel to Investigator Meetings as needed.
• Possess a willingness to assume responsibility for tasks outside of your current role and to work flexible hours as needed.
• Be able to step up and fill in as coordinator and assist in lab, if applicable.
• Other duties as assigned.
• Salary dependent on commensurate.

Qualifications:

• Minimum of 5 years of experience in clinical research, with 7-10 years preferred.
• Strong site management experience is highly desirable.
• Proven ability to lead and manage teams effectively.
• Excellent communication, interpersonal, and organizational skills.
• Demonstrated ability to multi-task and adapt to dynamic therapeutic areas.
• CITI certifications (GCP, HSC, RCR, COI, IPS, IATA, ICH, CRC) required within the first two weeks of hire (training provided).
• Bachelor’s degree in a related field required, master’s degree preferred.

Technical Skills:

• Experience with Electronic Data Capture systems and Real-Time Clinical Trial Management (CTMS) preferred.
• Proficiency in Microsoft Teams, PDF Filler, CTMS, and DocuSign.

Additional Requirements:

• Ability to travel locally and nationally as needed.
• Must be based out of the site office.
• Willingness to work flexible hours and take on tasks outside of the current role as needed.
• Ability to step in as a coordinator or assist in the lab if applicable.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience:

• Clinical research: 5 years (Required)

Ability to Commute:

• Centreville, AL 35042 (Required)

Ability to Relocate:

• Centreville, AL 35042: Relocate before starting work (Preferred)

Work Location: In person