Position Overview
Site Manager oversees all members of the practice participating in clinical research. 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 AMR’s Core Values:
· Excellence and Consistency
· Collaborative Innovation
· Respect for our Subjects, Sponsors and Team Members
· Community
· Unimpeachable Ethics
The Site Manager reports to the General Manager.
Classification: Exempt
Primary Responsibilities:
· Manage all clinical research staff including investigators, coordinators, lab, and research assistants 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 AMR SOP’s.
· Participate in the completion of the monthly Waterfall process in conjunction with managing sites/revenues for maximum site performance.
· 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 and 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.
· Implement all AMR SOPs and site manual procedures and ensure regular compliance.
· 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 responsibilityand expect accountability and regular feedback.
· Hire, train and develop new team members to meet organizational needs
· Consciously create a workplace cultureconsistent with the overall organization's and that emphasizes the identified mission, vision, guiding principles, and valuesof 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 onboardingand providing career development planningand 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
· Other duties as assigned
- Travel to Investigator Meeting 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
Desired Skills and Qualifications:
· At least 4 years of experience involving patient care in a healthcare environment. No less than 3 years of clinical research experience.
· Minimum of 4 years leading and managing teams required.
· Strong understanding of financials and performance metrics.
· Excellent people skills and proven success leading and managing teams.
· 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.
· Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.
· Comply with OSHA regulations.
· Previous training and experience in clinical research, Good Clinical Practice Guidelines, and all applicable FDA regulations, highly preferred.
· Ability to administer prescribed treatments according to protocol.
· Demonstrated ability to work with IRB submissions and correspondence.
· Demonstrated excellence in performance of the standard operating procedures.
· Critical thinking, analytical, mathematical skills.
· Regular and predictable attendance is an essential function.
Alliance of Multispecialty Research does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.
** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.
Job Type: Full-time
Pay: $90,000.00 - $95,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Paid time off
- Vision insurance
Schedule:
- Day shift
- Monday to Friday
Experience:
- Clinical trials: 3 years (Required)
- Clinical research: 3 years (Required)
- Leadership: 4 years (Required)
- Healthcare management: 3 years (Required)
Work Location: In person