Alliance For MultiSpecialty Research LLC

The Site Manager oversees the daily operations and site personnel participating in clinical research. This position performs a diverse role of managerial and administrative responsibilities. This includes but is not limited to analysis, advanced knowledge of study protocols, sound judgment, and strong managerial skills. To consistently embody AMR Clinical's Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Site Manager reports to the Clinical Site Directors/Associate Site Director. Classification: Exempt Primary 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 Desired Skills and Qualifications: 3 years of experience clinical research experience preferred. 4 year of experience in health care field required Minimum 4 years of experience leading and managing teams required. 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. 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. AMR Clinical 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. PI41d3a9bf3b13-7071

The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study. To consistently embody AMR Clinical's Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Clinical Research Coordinator reports to the Site Manager/Team Lead. Classification: Non-Exempt Primary Responsibilities: Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent. Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures. Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols. Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution. Establish understanding of SOP's and implement the SOP's Gain understanding of the pharmaceutical drug per clinical trial. Develop detailed knowledge of protocol and procedures per clinical research study. Communicate effectively with study sponsors, CROs, monitors/CRA's, IRBs, laboratories, and clinical personnel within the research industry. Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study. Establish and maintain patient rapport. Clinical data collection (vital signs, EKG recording, weight, height, etc.) Obtain medical records and review as required. Phlebotomy Specimen collection, processing, and storage Transporting clinical specimens to the laboratory. Educate subjects on diaries and oversees compliance with diary completion. Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.) Responsible for completing patient phone call visits in accordance to the standard protocol period. Ensure documentation follows ALCOA standards and is completed in a timely manner. Ensure all necessary documents are completed, signed and dated. Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required. Manage study inventory and order supplies as needed. Prepare and assist study monitors during onsite visits. Maintain familiarity with all ongoing clinical research studies. Travel to Investigator meetings as needed. Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties Position may require occasional weekend and/or overtime hours. Other duties as assigned Desired Skills and Qualifications: 1 year of experience in clinical research. Completion of formal medical training, educational program, or healthcare experience Strong medical terminology Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.). Ability to work independently and lead study-related tasks. Ability to multi-task in a high-paced evolving environment. Exceptional listening, written, and verbal communication skills as well. Demonstrate proficiency in office equipment and software programs. Excellent organizational and task management 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. AMR Clinical 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. Compensation details: 26-30 Hourly Wage PI0c997dd41afa-9559

The Site Manager oversees the daily operations and site personnel participating in clinical research. This position performs a diverse role of managerial and administrative responsibilities. This includes but is not limited to analysis, advanced knowledge of study protocols, sound judgment, and strong managerial skills. To consistently embody AMR Clinical's Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Site Manager reports to the Clinical Site Directors/Associate Site Director. Classification: Exempt Primary 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 Desired Skills and Qualifications: 3 years of experience clinical research experience preferred. 4 year of experience in health care field required Minimum 4 years of experience leading and managing teams required. 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. 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. AMR Clinical 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. PI305b93b7711a-7071

The Site Manager oversees the daily operations and site personnel participating in clinical research. This position performs a diverse role of managerial and administrative responsibilities. This includes but is not limited to analysis, advanced knowledge of study protocols, sound judgment, and strong managerial skills. To consistently embody AMR Clinical's Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Site Manager reports to the Clinical Site Directors/Associate Site Director. Classification: Exempt Primary 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 Desired Skills and Qualifications: 3 years of experience clinical research experience preferred. 4 year of experience in health care field required Minimum 4 years of experience leading and managing teams required. 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. 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. AMR Clinical 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. PIb4e5cc5c34e2-7071

The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study. To consistently embody AMR Clinical's Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Clinical Research Coordinator reports to the Site Manager/Team Lead. Classification: Non-Exempt Primary Responsibilities: Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent. Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures. Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols. Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution. Establish understanding of SOP's and implement the SOP's Gain understanding of the pharmaceutical drug per clinical trial. Develop detailed knowledge of protocol and procedures per clinical research study. Communicate effectively with study sponsors, CROs, monitors/CRA's, IRBs, laboratories, and clinical personnel within the research industry. Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study. Establish and maintain patient rapport. Clinical data collection (vital signs, EKG recording, weight, height, etc.) Obtain medical records and review as required. Phlebotomy Specimen collection, processing, and storage Transporting clinical specimens to the laboratory. Educate subjects on diaries and oversees compliance with diary completion. Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.) Responsible for completing patient phone call visits in accordance to the standard protocol period. Ensure documentation follows ALCOA standards and is completed in a timely manner. Ensure all necessary documents are completed, signed and dated. Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required. Manage study inventory and order supplies as needed. Prepare and assist study monitors during onsite visits. Maintain familiarity with all ongoing clinical research studies. Travel to Investigator meetings as needed. Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties Position may require occasional weekend and/or overtime hours. Other duties as assigned Desired Skills and Qualifications: 1 year of experience in clinical research. Completion of formal medical training, educational program, or healthcare experience Strong medical terminology Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.). Ability to work independently and lead study-related tasks. Ability to multi-task in a high-paced evolving environment. Exceptional listening, written, and verbal communication skills as well. Demonstrate proficiency in office equipment and software programs. Excellent organizational and task management 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. AMR Clinical 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. Compensation details: 26-30 Hourly Wage PIfa5-

The Site Manager oversees the daily operations and site personnel participating in clinical research. This position performs a diverse role of managerial and administrative responsibilities. This includes but is not limited to analysis, advanced knowledge of study protocols, sound judgment, and strong managerial skills. To consistently embody AMR Clinical's Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Site Manager reports to the Clinical Site Directors/Associate Site Director. Classification: Exempt Primary 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 Desired Skills and Qualifications: 3 years of experience clinical research experience preferred. 4 year of experience in health care field required Minimum 4 years of experience leading and managing teams required. 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. 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. AMR Clinical 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. PIb4e5cc5c34e2-7071