Site Manager

• Excellence and Consistency
• Collaborative Innovation
• Respect for our Subjects, Sponsors and Team Members
• Community
• Unimpeachable Ethics

Primary Responsibilities:

• Manage all clinical research staff including investigators, coordinators, lab, and research assistants to ensure optimal performance on each study.
• 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 AMR SOP’s.
• Complete monthly Waterfall.

• Responsible for meeting site revenue targets.
• Handle site budget and maximize EBITDA.
• Ensure accurate and complete drug/device distribution and accountability records of all investigational products 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, accurate and maintained by Coordinators/Data Managers per FDA requirements, sponsor requirements and AMR 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, as applicable.
• Implement and ensure regular compliance of AMR SOPs and site work processes.
• Ensure the research team provides sponsors with required information that is complete and accurate per research agreement.
• Inform sponsor and corporate QA of prospective FDA audits.
• Determine steps necessary to correct deficiencies identified in an FDA audit and implement changes. Notify General Manager of these 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 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.

• Other duties as assigned.

Desired Skills and Qualifications:

• At least 4 years of clinical experience involving patient care in a healthcare environment; no less than 3 years of clinical research experience highly preferred.
• Proven success leading and motivating teams highly preferred
• Demonstrated superior knowledge of the clinical research process preferred.
• Demonstrate leadership skills, including ability to effectively supervise individuals and 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.
• Comply with OSHA regulations.
• Previous training and experience in clinical research, Good Clinical Practice Guidelines, and all applicable FDA regulations.
• Demonstrated excellence in performance of the standard operating procedures.
• Critical thinking, analytical, mathematical skills.
• Regular and predictable attendance is an essential function.