AMR Clinical · 2 days ago
Site Manager
Knoxville, TN
Full-time
Onsite
Mid, Senior Level
4+ years expAMR Clinical is a company focused on clinical research, and they are seeking a Site Manager to oversee daily operations and site personnel involved in clinical studies. The Site Manager will manage clinical research staff, ensure compliance with protocols and regulations, and support the team in achieving optimal study performance.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Manage all site level clinical research staff to ensure optimal performance on each study
Implement AMR SOP’s and site manual procedures, ensuring compliance
Collaborate with team to develop and implement an effective enrollment plan to ensure consistent enrollment in line with sponsors protocol and enrollment period
Review and prepare the team of all components of a study prior to initiation date to ensure the teams understands their role and responsibilities for each study
Maintain accurate and complete drug/devise distribution and accountability records for all investigational products, including proper storage
Ensure compliance according to FDA regulations, GCP guidelines and AMR’s SOP
Provide direction and support to team during screenings to ensure qualified subjects are identified and enrolled in the study in a timely manner
Ensure Coordinators/Data Managers complete accurate case reports forms per AMR’s SOP, FDA and Sponsor requirements
Complete Vendor assessments for any vendors that can affect the integrity of company data
Prompt reporting of adverse events to the principal investigator, Sponsor, IRB in compliance with FDA regulations and sponsor requirements
Ensure serious adverse events are reported by the coordinator immediately to the Principal Investigator and within 24 hours to the Sponsor, CRO and IRB
Ensure complete and accurate information is sent to Sponsor as required per the agreement
Inform sponsors and AMR QA of upcoming/prospective FDA audits
Collaborate with QA to develop an action plan to correct deficiencies identified during the audit. Notify GM of changes
Meet and greet monitors during site visits
Complete accurate monthly waterfall in a timely manner
Manage sites revenues for maximum site performance
Interview potential candidates and identify new team members
Train and develop team members
Provide constructive feedback to team members in a timely manner
Coordinate and lead meetings with the team at least once a month
Lead employee performance evaluations and develop goals tailored to each team member
Comply with OSHA regulations
Study level tasks as delegated
Position may require occasional weekend and/or overtime hours
Other duties as assigned
Qualification
Required
4 year of experience in health care field required
Minimum 4 years of experience leading and managing teams required
Strong understanding of financials and performance metrics
Advance knowledge of computer software in a variety of programs, i.e. Word, excel, etc
Excellent task management and prioritization skills
Strong verbal and written skills
Critical thinking, analytical and mathematical skills
Great interpersonal skills
Keen and acute attention to detail
Ability to work independently and demonstrate initiative
Positive, collaborative, and team oriented
Ability to work in a fast-paced environment and multi-task in an evolving environment
Excellent follow-up skills
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
Must be fluent in English
Preferred
3 years of experience clinical research experience preferred
Demonstrates Superior knowledge of clinical research processes preferred
Previous training and experience in clinical research, good clinical practice guidelines, and all applicable FDA regulations, highly preferred
Company
AMR Clinical
At AMR Clinical, we are committed to doing research right.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
John Wathen
Chief Operating Officer
Kari Delahunty
Chief Operating Officer
Company data provided by crunchbase