Clinical research associate jobs in Flint, MI

The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **Key Accountabilities:** **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desirable):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as required. + Valid driving license per country requirements, as applicable \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

General Motors Research Labs is an applied research center focusing on creating and evaluating innovations for future vehicles. Our researchers conduct independent technical work, while initiating and leading collaborative projects with colleagues at academia and industry globally. As a member of General Motors Research Labs, the Vehicle Controls group offers exciting opportunities for motivated researchers with outstanding capabilities to conduct research in applied AI and Controls for developing cutting edge, world changing technologies for GM's future vehicles. The focus of this position will be to maximize contributions to the whole organization. **The Role:** In this **Senior Researcher position** , you will lead research and/or experiments to validate research ideas in development. Write timely and high-quality research reports, external publications, and records of invention to document new ideas and research results in your area of research. **What You Will Do** As a part of the GM Research team, you will lead novel applied AI and Controls research. You will develop AI/ML/Controls technologies that will change the future of mobility. You will collaborate with world-class universities / industry partners while publishing research outcomes internally and externally. Broader research areas include: + Explore, invent, innovate, implement, evaluate and test algorithms as an independent yet integral member of a research team + Identify research gaps, propose, plan and execute complex research projects + Maintain state-of-the-art technical expertise in AI/ML/Controls + Generate intellectual property, document results and publish papers + Demonstrate strong interpersonal skills and ability to work in a team environment including cross-functional global teams and research Universities + Develop requirements and evaluation metrics for AI/ML/Controls + Travel to GM's Milford location as needed to conduct experiments and testing **Your Skills & Abilities (Required Qualifications)** + U.S. Citizenship + PhD or MSc with 3+ years of experience in AI, ML, computer science, engineering, physics or relevant areas. + Expert-level knowledge in one or more of these areas: Control theory, autonomous agents, Robotics, and reinforcement learning + Must have experience creating and implementing control algorithms + Expertise in manipulating high-volume, high-dimensional data from varying sources with machine learning techniques + Experience in prototyping algorithms, implementing and testing software on hardware + Programming background: Python, AI/ML environments (PyTorch, TensorFlow, sklearn, etc.), Matlab, dSPACE + Strong analytical capabilities + Excellent verbal/written communication in English along with strong interpersonal skills + Passion for applying AI and Controls to impact the future of mobility **What Will Give You a Competitive Edge (Preferred Qualifications)** + Experience in applying reinforcement learning to real world problems. + Experience in applying ML techniques to control theory problems. + Expertise in vehicle dynamics **About GM** Our vision is a world with Zero Crashes, Zero Emissions and Zero Congestion and we embrace the responsibility to lead the change that will make our world better, safer and more equitable for all. **Why Join Us** We believe we all must make a choice every day - individually and collectively - to drive meaningful change through our words, our deeds and our culture. Every day, we want every employee to feel they belong to one General Motors team. **Benefits Overview** From day one, we're looking out for your well-being-at work and at home-so you can focus on realizing your ambitions. Learn how GM supports a rewarding career that rewards you personally by visiting Total Rewards resources (************************************************************* . **Non-Discrimination and Equal Employment Opportunities (U.S.)** General Motors is committed to being a workplace that is not only free of unlawful discrimination, but one that genuinely fosters inclusion and belonging. We strongly believe that providing an inclusive workplace creates an environment in which our employees can thrive and develop better products for our customers. All employment decisions are made on a non-discriminatory basis without regard to sex, race, color, national origin, citizenship status, religion, age, disability, pregnancy or maternity status, sexual orientation, gender identity, status as a veteran or protected veteran, or any other similarly protected status in accordance with federal, state and local laws. We encourage interested candidates to review the key responsibilities and qualifications for each role and apply for any positions that match their skills and capabilities. Applicants in the recruitment process may be required, where applicable, to successfully complete a role-related assessment(s) and/or a pre-employment screening prior to beginning employment. To learn more, visit How we Hire (********************************************* . **Accommodations** General Motors offers opportunities to all job seekers including individuals with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, email (Careers.Accommodations@GM.com) us or call us at ************. In your email, please include a description of the specific accommodation you are requesting as well as the job title and requisition number of the position for which you are applying. We are leading the change to make our world better, safer and more equitable for all through our actions and how we behave. Learn more about: **Our Company (************************************************** **Our Culture** **How we hire (************************************************ Our diverse team of employees bring their collective passion for engineering, technology and design to deliver on our vision of a world with Zero Crashes, Zero Emissions and Zero Congestion. We are looking for adventure-seekers and imaginative thought leaders to help us transform mobility. Explore our global locations (******************************************** We are determined to lead change for the world through technology, ingenuity and harnessing the creativity of our diverse team. Join us to help lead the change that will make our world better, safer and more equitable for all by becoming a member of GM's Talent Community (beamery.com) (*********************************************** . As a part of our Talent Community, you will receive updates about GM, open roles, career insights and more. Please note that filling out the form below will not add you to our Talent Community automatically; you will need to use the link above. If you are seeking to apply to a specific role, we encourage you to click "Apply Now" on the job posting of interest. 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JOB SUMMARY The Clinical Research Coordinator (CRC) is a specialized research professional working with, and under the direction of the clinical Principal Investigator (PI) on multiple ongoing research studies. Utilizing Good Clinical Practice, the Clinical Research Coordinator ensures assigned studies are conducted in accordance with Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), local regulations; Institutional Review Board Approvals, and Memorial Healthcare policies and procedures.# While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for providing knowledgeable information regarding each research protocol to Memorial Healthcare staff; evaluating the eligibility of potential candidates for research studies; assisting in the informed consent process; monitoring research study compliance; collecting and submitting data; coordinating required study procedures to meet protocol requirements and data management. Additionally, this position will provide support for improved practice and patient outcomes as well as collaborations with other healthcare professionals to provide care, health promotion and education. Strive for superior performance by consistently providing a product or service to leadership and staff recognized as ultimately contributing to the patient and family experience. Recognizes and demonstrates an understanding of patient and family-centered care. # PRIMARY JOB RESPONSIBILITIES Ensures human subject protections via diligence in research participant screening, recruitment, consenting, enrollment, randomization, monitoring of treatment, and follow-up procedures, ongoing risk assessment related to research interventions and protocol activities. Ensures ongoing research informed consent, addresses participant questions throughout study participation, and supports their goal for participating or terminating study participation. # Coordinates research activities to minimize participant risk and ensure participant safety. Distributes study article (drugs, devices), and maintains study article accountability documentation. Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration and disease treatment. Prepares, processes and ships biological samples per study protocols and International Air Transport Association (IATA) requirements. Ensures appropriate credentialing and training of the Memorial Healthcare staff as it relates to research and protocol requirements. Ensures scientific integrity of data and maintains participant privacy, confidentiality, and safety of patients enrolled in clinical trials. Develops source documentation forms and tools per study protocol requirements. Documents all study-related procedures/events via electronic data capture systems, case report forms, etc. Communicates effectively with research participants and their families, the research team, principal investigators, external study sponsors, primary care providers (e.g., clinical nurses, physicians, etc.), ancillary staff and the IRB to ensure protocol adherence, participant safety and regulatory compliance. Participates in study site activation activities, including regulatory documentation, training of research team and impacted departments. Participates in clinical study planning for Investigator Initiated Trials, Sponsored Research Agreements. Prepares and conducts training activities for assigned trials. Number of trials depends on phase, number of enrolled subjects and complexity of study. Assists with internal and external site audits. Supports regulatory efforts in the maintenance of regulatory documents in accordance with Memorial Healthcare Standards of Practice and applicable regulations. Assists in the maintenance of clinicaltrials.gov information for Investigator Initiated Trials and Sponsored Research Agreements. Promotes research revenue cycle best practices through the communication of protocol coverage as outline in study#s Medicare Coverage Analysis (modifier codes, and secondary diagnosis etc.). Maintains accurate documentation of study stipend and reimburse per study protocol informed consent and budget. Acts as a liaison between site, investigators, principal investigator, Memorial Healthcare, IRBs and study sponsors. Creates study related reports as requested. Participates in meetings and provides information regarding applicable clinical trials. Participates in continuing education activities related to research to improve knowledge for job performance. Ensures compliance with research protocols by providing ongoing quality control audits. Participates with the PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance. Maintains IATA, Good Clinical Practice and other certifications as required. Occasional travel to satellite sites and to attend sponsor study training meetings as required Performs other duties as assigned. # JOB SPECIFICATIONS EDUCATION 1. Bachelor#s degree in a scientific, health related, or business administration program preferred. At a minimum, a candidate must have a Bachelor#s degree with recent experience in a clinical setting. # EXPERIENCE Minimum 2 year prior clinical experience or equivalent clinical trial experience. 1-2 year experience with research related activities with clinical practice, ICH guidelines, FDA and OHRP regulations, IND, SAE reporting, and protection of human research participant standards, regulations and laws preferred. MS Word, Excel, Outlook, EMR experience required. BLS # SPECIALIZED CERTIFICATES/LICENSES: Clinical Research Certification CCRC/CCRP preferred, but not required. # ESSENTIAL PHYSICAL ABILITIES/MOTOR SKILLS/SENSORY REQUIREMENTS These physical requirements are not exhaustive and additional job-related physical requirements may be added on an as needed basis. Corrective devices may be used to meet physical requirements. Sedentary Work: Frequently required to stand, kneel and crouch. On a daily basis may be required to move about, sit, climb stairs and bend. Is frequently required to lift and carry up to 20 lbs. May be required to push/pull/carry items between 20-100 lbs. Vision: Requires the ability to perceive the nature of objects by the eye. Near acuity: Clarity of vision at 20 inches or less. Midrange Acuity: Clarity of vision at distances of more than 20 inches and less than 20 feet. Motor Coordination: While performing the duties of the job, it is required to regularly perform functions that include using hand and finger movement, handle or feel objects, be able to use tools or equipment that requires reaching with hands and arms. Must be able to travel independently throughout hospital; access patients/families including areas confined by space and/or equipment. Speaking/Hearing: Ability to give and receive information through speaking and listening skills. # ESSENTIAL TECHNICAL ABILITIES Able to navigate computer systems and enter data into database. Use of Microsoft Office Products Computer and basic office equipment proficiency required. # ESSENTIAL MENTAL ABILITIES Motivated #self-starter# with ability to exercise initiative. Detailed oriented with strong written and verbal communication skills. Able to problem solve. Identifies and resolves problems in a timely manner. Gathers and analyzes information skillfully. Analytical, prioritization and planning of work activities. Adapts for changing conditions. Ability to manage multiple priorities. # INTERPERSONAL SKILLS Can apply effective interpersonal skills to provide service. Comfortable working in a team environment as well as independently. Adapts to changes in the work environment. JOB SUMMARY The Clinical Research Coordinator (CRC) is a specialized research professional working with, and under the direction of the clinical Principal Investigator (PI) on multiple ongoing research studies. Utilizing Good Clinical Practice, the Clinical Research Coordinator ensures assigned studies are conducted in accordance with Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), local regulations; Institutional Review Board Approvals, and Memorial Healthcare policies and procedures. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for providing knowledgeable information regarding each research protocol to Memorial Healthcare staff; evaluating the eligibility of potential candidates for research studies; assisting in the informed consent process; monitoring research study compliance; collecting and submitting data; coordinating required study procedures to meet protocol requirements and data management. Additionally, this position will provide support for improved practice and patient outcomes as well as collaborations with other healthcare professionals to provide care, health promotion and education. Strive for superior performance by consistently providing a product or service to leadership and staff recognized as ultimately contributing to the patient and family experience. Recognizes and demonstrates an understanding of patient and family-centered care. PRIMARY JOB RESPONSIBILITIES * Ensures human subject protections via diligence in research participant screening, recruitment, consenting, enrollment, randomization, monitoring of treatment, and follow-up procedures, ongoing risk assessment related to research interventions and protocol activities. * Ensures ongoing research informed consent, addresses participant questions throughout study participation, and supports their goal for participating or terminating study participation. * Coordinates research activities to minimize participant risk and ensure participant safety. * Distributes study article (drugs, devices), and maintains study article accountability documentation. * Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration and disease treatment. * Prepares, processes and ships biological samples per study protocols and International Air Transport Association (IATA) requirements. * Ensures appropriate credentialing and training of the Memorial Healthcare staff as it relates to research and protocol requirements. * Ensures scientific integrity of data and maintains participant privacy, confidentiality, and safety of patients enrolled in clinical trials. * Develops source documentation forms and tools per study protocol requirements. * Documents all study-related procedures/events via electronic data capture systems, case report forms, etc. * Communicates effectively with research participants and their families, the research team, principal investigators, external study sponsors, primary care providers (e.g., clinical nurses, physicians, etc.), ancillary staff and the IRB to ensure protocol adherence, participant safety and regulatory compliance. * Participates in study site activation activities, including regulatory documentation, training of research team and impacted departments. * Participates in clinical study planning for Investigator Initiated Trials, Sponsored Research Agreements. * Prepares and conducts training activities for assigned trials. Number of trials depends on phase, number of enrolled subjects and complexity of study. * Assists with internal and external site audits. * Supports regulatory efforts in the maintenance of regulatory documents in accordance with Memorial Healthcare Standards of Practice and applicable regulations. * Assists in the maintenance of clinicaltrials.gov information for Investigator Initiated Trials and Sponsored Research Agreements. * Promotes research revenue cycle best practices through the communication of protocol coverage as outline in study's Medicare Coverage Analysis (modifier codes, and secondary diagnosis etc.). * Maintains accurate documentation of study stipend and reimburse per study protocol informed consent and budget. * Acts as a liaison between site, investigators, principal investigator, Memorial Healthcare, IRBs and study sponsors. * Creates study related reports as requested. * Participates in meetings and provides information regarding applicable clinical trials. * Participates in continuing education activities related to research to improve knowledge for job performance. * Ensures compliance with research protocols by providing ongoing quality control audits. * Participates with the PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance. * Maintains IATA, Good Clinical Practice and other certifications as required. * Occasional travel to satellite sites and to attend sponsor study training meetings as required * Performs other duties as assigned. JOB SPECIFICATIONS EDUCATION 1. Bachelor's degree in a scientific, health related, or business administration program preferred. At a minimum, a candidate must have a Bachelor's degree with recent experience in a clinical setting. EXPERIENCE * Minimum 2 year prior clinical experience or equivalent clinical trial experience. * 1-2 year experience with research related activities with clinical practice, ICH guidelines, FDA and OHRP regulations, IND, SAE reporting, and protection of human research participant standards, regulations and laws preferred. * MS Word, Excel, Outlook, EMR experience required. * BLS SPECIALIZED CERTIFICATES/LICENSES: * Clinical Research Certification CCRC/CCRP preferred, but not required. ESSENTIAL PHYSICAL ABILITIES/MOTOR SKILLS/SENSORY REQUIREMENTS These physical requirements are not exhaustive and additional job-related physical requirements may be added on an as needed basis. Corrective devices may be used to meet physical requirements. * Sedentary Work: Frequently required to stand, kneel and crouch. On a daily basis may be required to move about, sit, climb stairs and bend. Is frequently required to lift and carry up to 20 lbs. May be required to push/pull/carry items between 20-100 lbs. * Vision: Requires the ability to perceive the nature of objects by the eye. Near acuity: Clarity of vision at 20 inches or less. Midrange Acuity: Clarity of vision at distances of more than 20 inches and less than 20 feet. * Motor Coordination: While performing the duties of the job, it is required to regularly perform functions that include using hand and finger movement, handle or feel objects, be able to use tools or equipment that requires reaching with hands and arms. Must be able to travel independently throughout hospital; access patients/families including areas confined by space and/or equipment. * Speaking/Hearing: Ability to give and receive information through speaking and listening skills. ESSENTIAL TECHNICAL ABILITIES * Able to navigate computer systems and enter data into database. * Use of Microsoft Office Products * Computer and basic office equipment proficiency required. ESSENTIAL MENTAL ABILITIES * Motivated "self-starter" with ability to exercise initiative. * Detailed oriented with strong written and verbal communication skills. * Able to problem solve. Identifies and resolves problems in a timely manner. Gathers and analyzes information skillfully. * Analytical, prioritization and planning of work activities. * Adapts for changing conditions. * Ability to manage multiple priorities. INTERPERSONAL SKILLS * Can apply effective interpersonal skills to provide service. Comfortable working in a team environment as well as independently. * Adapts to changes in the work environment.

The Director Clinical Sciences, Hematology, leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Director leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and late phase development. The Director reports to the Senior Director Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. The director will be responsible for managing a team of clinical scientists. As a Director in Hematology, a typical day may include the following: * May function as lead Clinical Scientist (CS) for program, and/or as delegate of Therapeutic area (TA) Lead Clinical Scientist; Member of the Clinical Study Team and Global Clinical SubTeam * Line Manager for CS team and serves as key functional advisor or representative for the CS group; ensures alignment of process and procedures for CS across assigned assets/programs in alignment with TA expectation; Guides assigned Program teams/direct reports * Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments * Applies advanced scientific expertise to propose, design, and execute clinical research and development studies for early and late stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature * Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and resolve cross functional comments independently; Independently leads planning and prepares information for external /stakeholder meetings (IM, Governance, IDMCs, Regulatory Authorities) * Performs and mentors direct reports in clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety * Applies advanced analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies; Identifies areas of potential inconsistent data review * Ensures consistent first line medical/clinical data review techniques and conventions across studies/programs; leads drafting/updating/review of clinical data review plan and medical monitoring plans; ensures execution where appropriate for assigned studies/programs This role may be for you if: * Exhibits high level of skill in building team and mentoring direct reports * Ability to lead activities within a matrix environment; Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally; Demonstrated ability to influence within team and department and may influence across functionally * Demonstrates exceptional initiative, creativity and innovation skills. Directly contributes to the development of innovations. Identifies opportunities to initiate operational changes * Strong direct-line and cross-functional management, interpersonal and problem-solving skills To be considered for this position, you must have a bachelor's degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc). Additionally, ≥ 10 years of pharmaceutical clinical drug development experience. We are specifically seeking experience with lymphoma/hematology oncology, and a minimum of 4 years of direct and/or indirect management experience. Proven understanding of therapeutic disease areas and drug candidates including underlying disease biology, clinical manifestations and therapeutic standard practice, compounds including mechanism of action and drug landscape. Other levels considered depending on experience. #Hematology Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $202,000.00 - $336,600.00

Internal Job Description Job Title: Clinical Research Coordinator Work Set-Up: Working On-site Schedule: 16 hours per week. Responsibilities: * Phlebotomy is required, and pediatric experience is also needed. Additionally, community outreach will be part of the role. * Perform a variety of complex clinical procedures on subjects including but not limited to ECG, sample collection including spirometry, and vital signs. * Coordinate clinical research studies conducted by a supervising principal investigator. * Update and maintain skills, training, and knowledge of current best nursing practices and topics related to clinical research. * Safeguard the well-being of the subjects and ensure and maintain high standards: * Maintain a safe environment in accordance with Health and Safety policies. * Act as a volunteer advocate. * Address volunteer and visitor concerns proactively and take remedial action as required. * Assist staff, both registered and unregistered, in clinical coordinator practices and the delivery of care to the volunteer. * Report any deviation from normal practice to senior staff. Support Study Conduct By: * Reviewing the study protocol, case report form (CRF), other study documents, and electronic data capture systems. * Participating in project meetings with the project team as needed. * Performing clinical set-up and preparation for the study including labeling specimen collection tubes and containers, setting up equipment and documents. * Planning logistical activity for procedures as per protocol. * Generating volunteer instructions. * Identifying and obtaining required supplies and equipment. * Preparing and delivering study-specific training materials, documents, and records. * Troubleshooting study issues. * Participating in huddles to ensure daily tasks assigned to team members are executed to the expected standards. * Assisting with data quality checking and query resolution to ensure that data collected on study volunteers adhere to study protocol and ensuring quality control for content accuracy and completeness. * Recruiting and screening volunteers for inclusion in the study based on pre-determined criteria. * Orienting volunteers to the study and the site including the purpose of the study, procedures, and practical issues such as timelines for visits. * Responsible for the correct administration and custody of study drug according to site standard operating procedures. * Collecting, recording, and reporting clinical data and findings appropriately in case report forms (CRFs). Collaborating closely with the study investigator, informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol. * Cooperating with the study monitor and reserving sufficient time for questions during monitoring. * Following ICH GCP guidelines with regards to all study and patient activities. Qualifications: * Equivalent education and experience - High School Diploma and 1 years' relevant work experience in clinical research * At least 1 year experience working in a clinical research setting preferred. * Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies. * Working knowledge of clinical trials. * Working knowledge of the principles of Good Clinical Practices (GCP). * In-depth knowledge of protocol and study-specific operating procedures, consent forms, and study schedules. * Skill in carrying out required clinical procedures. * Working knowledge of medical terminology. * Ability to pay close attention to detail. * Ability to establish and maintain effective working relationships with coworkers, managers, patients, physicians, and clients. Please note, this position is not eligible for sponsorship. #LI-CES and #LI-DNP #LI-HCP #ONSITE IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role is $35.00-$42.00 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Join our growing Clinical Trials Unit (CTU) in Plymouth, MI, where we conduct innovative, high-impact clinical trials across expanding therapeutic areas. Since 2014, our collaborative team has thrived in a fast-paced environment focused on accuracy, participant safety, and operational excellence. We anticipate continued growth and offer opportunities for advancement to skilled Clinical Research Coordinators. This is a full-time position; however, part-time scheduling may be considered for highly qualified candidates. While most work will require on-site presence, there is opportunity to work 1 day remote dependent on project needs. Most shifts occur during daytime hours, though occasional evening, overnight, or weekend coverage may be required depending on study needs. Job Summary The Clinical Research Coordinator III (CRC III) is an advanced-level role responsible for independently coordinating complex clinical research studies from startup through closeout. This position requires strong clinical research knowledge, clinical trial experience, advanced protocol management skills, and the ability to support multiple studies simultaneously. The CRC III plays a critical role in participant recruitment, enrollment, visit execution, data management, and biospecimen handling while ensuring compliance with ICH-GCP, FDA, and sponsor requirements. The CRC III may also support regulatory submissions and serve as a resource to junior staff. Responsibilities Actively participates in participant recruitment, screening, informed consent, and enrollment. Coordinates complex study visits and procedures in accordance with protocol requirements. Oversees accurate data collection, source documentation, and entry into EDC systems. Performs data cleaning and resolves queries within sponsor-required timelines. Collects, processes, labels, stores, and ships biospecimens per laboratory manual specifications. Monitors participant safety, clinical status, and adverse events; ensures timely reporting. Ensures compliance with ICH-GCP, FDA, OHRP, HIPAA, and sponsor requirements. Manages regulatory components of studies, including maintaining the electronic Investigator Site File (eISF). Prepares for and participates in monitoring visits, SIVs, SQVs, and closeout visits. Provides mentorship and guidance to CRC I and CRC II team members. Participates in team meetings, investigator meetings, and sponsor-required trainings. Collaborates with investigators, clinicians, and research staff to support study execution. Assists in developing recruitment materials, source documents, and study tools. Maintains awareness of industry best practices and evolving research regulations. Qualifications Required Qualifications Bachelor's degree in health science, medical, or related discipline. 4-6 years of experience working with commercial clinical trials. BLS and/or ACLS certification. Proficiency with Microsoft Office and common EDC systems. Strong understanding of ICH-GCP, FDA, OHRP, and HIPAA regulations. Experience with biospecimen collection, processing, and shipping. Excellent organizational and problem-solving skills with ability to manage multiple studies. Strong communication and leadership ability. Ability to maintain strict confidentiality and data security. U.S. Citizenship or Permanent Residency required. Preferred Qualifications ACRP-CCRC or SOCRA certification. Extensive knowledge of medical terminology, clinical lab assessments, and pharmacovigilance. Experience with IRB processes and regulatory submission platforms (e.g., ePortal). Candidate Traits Highly detail-oriented with exceptional organizational skills. Strong leadership abilities with experience mentoring junior staff. Proactive problem solver with ability to work in a dynamic environment. Strong interpersonal skills and ability to collaborate with cross-disciplinary teams. Self-motivated and able to work independently while upholding ethical standards. The salary range is: $64,396-$82,400/annually. Salary ranges will vary and are based on several factors, including geographic location, market competitiveness and equity amongst internal employees in similar roles. Positions may also qualify for SRI's Pay for Outstanding Performance program or the annual Performance Based Compensation program. SRI also has a competitive benefits package, to view details please go to **************************************** SRI will accept applications until the position is filled. SRI is an independent nonprofit research institute headquartered in Menlo Park, Calif., with a rich history of supporting government and industry. We create and deliver world-changing solutions for a safer, healthier, and more sustainable future. For more than 75 years, we have collaborated across technical and scientific disciplines to discover and develop groundbreaking products and technologies and bring innovations and ideas to the marketplace.

Job Description Unique opportunity to make an Impact in the healthcare industry… Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, and Arizona. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials. As Revival Research Institute is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us. We are seeking International Medical Graduates with a minimum of 1 year of research experience. Additionally, someone with a strong interest in the Clinical Research field would be an excellent fit for our entry level position, with room to grow. However, this interest and background is not necessary, as our ideal candidate is an individual who is detail orientated, being able to maintain organized records, as well as someone who is motivated to learn new things, as our company is always growing and expanding into new therapeutic areas. We are looking for individuals that want the opportunity to learn and grow with us. New Staff should be genuinely respectful of diverse points-of-view and strive for an environment in which inclusiveness drives productivity and results. Some responsibilities will include coordinating and managing multiple studies. They are also responsible for assisting the Principal Investigators and other clinical staff, with any study related tasks as follows but not limited to: Research participant screening, recruitment and enrollment. Consent and conduct research visits for data collection/no risk trials or no study article/minimal risk trials with oversight. Responsible for collecting, processing and shipping of research specimens, where applicable. Document study related information in case report forms or electronic data capture systems, handles data queries and participates in monitoring visits. Obtain, review and maintain source documents. Maintain organization of all trial related documents and correspondence. Implement quality control and assurance methods. Communicate with study sponsors, research team and the Institutional Review Board. Assist with basic regulatory document preparation, with oversight e.g. study amendments, adverse event reporting, protocol deviation reporting. Maintain professional and technical knowledge of Clinical trials and Standards of Care. Protect patient confidentiality. Preferred Qualifications Education/ Training: International Medical Graduate; MBBS, BMBS, MBChC, MBBCh, MD, DO, MCM, DM, MCM, MMSc, MMedSc, MM, MMed, MS, MSurg, MChir, MCh, ChM, CM, MSc, DCM, DClinSurg, DMSc, DMedSc, DS, DSurg Radiology experience is preferred. Phlebotomy skills are also preferred. Additional Qualifications: Database and computer skills: Microsoft Office (Word, Excel), Outlook, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. Maintain data integrity within the department. Must be able to work in a team consisting of physicians, nurses, technicians, secretarial staff and ancillary hospital staff. Knowledge of FDA Regulations and Good Clinical Practices. JOIN US & GROW YOUR KNOWLEDGE & EXPERIENCE!!! Powered by JazzHR QGxQV2prTk

Insight Institute of Neuroscience & Neurosurgery (IINN) aims to advance, challenge, and revolutionize neurosciences and medicine through scientific research and advanced technology, driven by a passion to help others regardless of any obstacles and challenges that may lie ahead. Our integrated team of medical professionals does so through creative, innovative techniques and care principles developed because of our continuous pursuit to improve the field of medicine. Our integrated team works together to find solutions to both common and complex medical concerns to ensure more powerful, reliable results. Having multiple specialties “under one roof” Insight achieves its purpose in providing a comprehensive, collaborative approach to neuromusculoskeletal care and rehabilitation to ensure optimal results. Our singular focus is Patient Care Second to None! Job Summary: We are seeking competent, proactive, self-directed individuals with effective time management skills to assist our clinical research site. The Clinical Research Assistant will support the clinical research team at our Research Dearborn location. They will work under the direction of the Clinical Research Manager. Job Type: Full time (on-site, in-person) Monday to Friday, Full-time (8 hours), 8am - 5pm EST Ability and willingness to commute between our research locations as needed per study tasks Professional references may be required. Benefits for our Full Time Team Members: Comprehensive health, dental, and vision insurance coverage Paid time off, including vacation, holidays, and sick leave 401K with Matching; offerings vested fully @ 3 months of employment paired with eligibility to contribute Short & Long Disability, and Life Term insurance, complementary of Full Time Employment Additional Supplementary coverages offered @ employee's elections: Accident, Critical Illness, Hospital Indemnity, AD&D, etc. Duties and Responsibilities: Schedule visit appointments after coordination with relevant parties Coordinate collection, processing and shipping of study specimens Assemble study kits for study visits Attend and participate in study meetings, SIVs, monitoring visits and other sponsor and regulatory meetings Complete Data Entry for studies both in sponsor EDC and CTMS Ensure all paper sources are filed and securely kept in the binders Assist and work closely with the Clinical Research Coordinator and Clinical Research manager in executing and monitoring the overall clinical study to ensure compliance with protocol Report any adverse events according to the study protocol Identify and assist in pre-screening potential subject leads Assist in marketing the active trials in the community Actively meet with investigator and study team to discuss study progress/status Provides administrative updates on enrollment and queries if any Other duties as needed per assigned study protocol Qualifications: Ability to demonstrate authorization to work in the U.S. for any employer Bachelor's degree or equivalent training required via work experience or education At least one year of previous job-related experience preferred Ability to follow oral and written instructions and established policies and procedures Ability to analyze and interpret data Ability to finish tasks in a timely manner Ability to maintain accuracy and consistency Ability to maintain confidentiality Ability to work as an effective team member Knowledge of medical terminology Ability to function independently and manage their own time and work tasks Diligent, thorough in their tasks, and show their commitment to their job Insight is an equal opportunity employer and values workplace diversity!

Job Description We are seeking a highly organized and motivated Clinical Research Coordinator (CRC) to join our research team. The CRC will coordinate and support all aspects of clinical trials and research studies, including subject recruitment, data collection, regulatory compliance, and specimen handling. Candidates with current Phlebotomy certification or Medical Assistant (MA) certification are strongly preferred, as this role may include specimen collection and basic clinical procedures. Key Responsibilities: Coordinate day-to-day clinical research activities to ensure study protocols are followed. Recruit, screen, and enroll study participants. Obtain informed consent and ensure ethical conduct in all study interactions. Collect, process, and ship biological specimens per protocol (e.g., blood draws, urine samples). Perform basic clinical procedures as permitted by certification (e.g., vital signs, EKGs). Maintain accurate and timely documentation in case report forms and electronic databases. Communicate with sponsors, monitors, and IRBs regarding study progress and compliance. Schedule participant visits and follow-ups; ensure visit windows are met. Ensure proper storage, handling, and accountability of investigational products, if applicable. Maintain regulatory documents and assist with IRB submissions. Qualifications: Bachelor's degree in a health-related field or equivalent experience. At least 2 years of experience in clinical research preferred. State Phlebotomy license required MA certification preferred Knowledge of Good Clinical Practice (GCP) and regulatory guidelines. Excellent organizational skills and attention to detail. Strong interpersonal and communication skills. Proficiency in Microsoft Office and electronic data capture systems (e.g., REDCap, EDC platforms). Ability to work independently and as part of a multidisciplinary team. Preferred Qualifications: Experience working in clinical trials at the research site level Familiarity with IRB processes and clinical trial documentation. Bilingual skills (depending on patient population) may be a plus.

Full-time Description Clinical Research Coordinator, RN's are primarily responsible for study coordination and data management, with a central focus on managing subject recruitment and enrollment, consistency of study implementation, data management and integrity, and compliance with regulatory requirements and reporting. Requirements ESSENTIAL JOB FUNCTION/COMPETENCIES The responsibilities and duties described in this job description are intended to provide a general overview of the position. Duties may vary depending on the specific needs of the affiliate or location you are working at and/or state requirements. Responsibilities include but are not limited to: Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner. Educates and directs protocol compliance with physicians and staff. Assists in developing tools to meet requirements of new protocols. Manages protocols with increased clinical complexities including translational investigator-initiated research as well as multi center trials. Ensure good documentation practices are applied by all team members when collecting, maintaining, and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms. Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. Acts as a patient advocate by providing education to and responding to questions from patients about protocols. Works with patients to ensure adherence with the protocol. Collaborates with scheduling staff to assure that future appointments for the patients (follow up visits and diagnostic testing) are scheduled correctly and timely. Collaborates with the physician to assure orders for treatment are written per protocol and delivered at the prescribed protocol intervals. Performs other position related duties as assigned. Employees shall adhere to high standards of ethical conduct and will comply with and assist in complying with all applicable laws and regulations. This will include and not be limited to following the Solaris Health Code of Conduct and all Solaris Health and Affiliated Practice policies and procedures; maintaining the confidentiality of patients' protected health information in compliance with the Health Insurance Portability and Accountability Act (HIPAA); immediately reporting any suspected concerns and/or violations to a supervisor and/or the Compliance Department; and the timely completion the Annual Compliance Training. CERTIFICATIONS, LICENSURES OR REGISTRY REQUIREMENTS BLS certification required, ACLS preferred. RN licensure and certifications as required by State. Clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) preferred. KNOWLEDGE | SKILLS | ABILITIES Ability to Start IVs and Administer IV medications Ability to draw blood Understanding of all aspects of biomedical research protocols, ensuring applicable regulations, and guidelines. Maintains patient confidentially. Excellent verbal and written communication skills. Skill in using computer programs and applications. Maintains current knowledge and awareness of organizational and regulatory standards, policies and procedures. Excellent organizational skills and attention to detail. Ability to build relationships with patients and display empathy and compassion to patients Skill in using computer programs and applications including Microsoft Office. Complies with HIPAA regulations for patient confidentiality. Complies with all health and safety policies of the organization. EDUCATION REQUIREMENTS Must be a Registered Nurse (RN) with a current and valid license. Associate's or Bachelor's degree in Nursing (ASN or BSN) required. EXPERIENCE REQUIREMENTS 2 or more years Nursing experience in ICU, ER, oncology or clinical trial experience, preferred. REQUIRED TRAVEL May require travel to other site locations in practice. May require travel to Investigator and other meetings. PHYSICAL DEMANDS Carrying Weight Frequency 1-25 lbs. Frequent from 34% to 66% 26-50 lbs. Occasionally from 2% to 33% Pushing/Pulling Frequency 1-25 lbs. Seldom, up to 2% 100 + lbs. Seldom, up to 2% Lifting - Height, Weight Frequency Floor to Chest, 1 -25 lbs. Occasional: from 2% to 33% Floor to Chest, 26-50 lbs. Seldom: up to 2% Floor to Waist, 1-25 lbs. Occasional: from 2% to 33% Floor to Waist, 26-50 lbs. Seldom: up to 2% Version 6.2.25

Posting Details: We are hiring a contingent / PRN workforce to assist with covering shifts at our Behavioral Health Urgent Care. General Statement: Under the direction of the Program Supervisor, conducts crisis and safety assessment, crisis intervention, and other clinical evaluations in the office, via telehealth, and the community; communicates and consults with a variety of agencies regarding program issues, assesses clinical needs and makes recommendations for support service and treatment; performs professional therapeutic crisis intervention; participates in and leads clinical team meetings for high risk cases; communicates and consults with staff from internal and external programs to assist with treatment recommendations; serves as a resource to staff; provides liaison, consultation and mental health education services for community agencies and resources persons; performs related work as required. Minimum Requirements: Educational Requirement License Requirements Year(s) of Experience Board Examination Masters in Social Work (LMSW) Michigan Master Level Social Worker (LMSW) credential, Clinical. One (1) year experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. Limited License Masters of Social Work (LLMSW) Limited License as a Masters Level Social Worker (LLMSW), credential. Three (3) years' experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. The employee with Limited License must take and pass the ASWB Examination within six (6) years in accordance with the State of Michigan requirements to retain employment. NOTE: GHS will follow all State of Michigan requirements. If the requirements change, the job description will be updated to reflect such changes. All licensed clinical staff must maintain licensure as a condition of employment. Master's in Psychology (LLP) Michigan Master Level Psychologist (LLP) credential. One (1) year experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. Temporary Limited License Psychologist (TLLP) Limited License as a Masters Level Psychologist (TLLP). Three (3) years' experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. The employee with a TLLP must pass the Exam for Professional Practice in Psychology (EPP) AND make application for the LLP within 18 months of hire OR prior to the expiration of the TLP, whichever is sooner to retain employment. Master's in Counseling (LPC) Michigan License Professional Counselor (LPC) credential. One (1) year experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. Limited License Master's in Counseling Limited License Professional Counselor (LLPC) credential. Three (3) years' experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. The employee with an LLPC must take and pass the National Counselor Examination (NCE) within six (6) years of hire to retain employment. The employee with an LLPC must also make application for the LPC upon passing the NCE. Registered Nurse(RN) Licensed as a Registered Nurse (RN) Three (3) years' experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. Additional Requirements: Minimum of 1 year of experience providing crisis services to include crisis assessment with level of care determination/recommendation, safety screening, and/or safety planning. Employee must maintain valid clinical licensure to retain employment. Must retain MDHHS qualifications as a Child Mental Health Professional. Must be willing and able to work weekends, holidays, various shifts, and irregular hours including on call responsibilities. Must be willing to provide services in person or via use of telehealth technology in office, community, or in the field including transporting consumers in crisis to services. If providing telehealth services, must have a work space in which service provision can occur in a confidential manner. Must have a valid Michigan driver's license, current automobile insurance, and the use of a vehicle during work hours. Ability to physically perform the tasks. Additional Requirements: Employee must maintain valid clinical licensure to retain employment. Must be willing and able to work weekends, holidays, or irregular hours including on call responsibilities. Must be willing to provide services via use of telehealth technology. Must have a valid Michigan driver's license, current automobile insurance, and the use of a vehicle during work hours. Ability to physically perform the tasks. If providing telehealth services, must have a work space in which service provision can occur in a confidential manner. Must retain MDHHS qualifications as a Child Mental Health Professional. Preferences: Minimum of 1 year of experience providing crisis services to include crisis assessment with level of care determination/recommendation, safety screening, and/or safety planning. Experience working with both adults and children with mental illness and/or developmental disabilities. Certification in Addiction Counseling (CAC) or in process to become a Certified Co-Occuring Disorders Professional - Diplomat (CCDP-D) OR a Certified Advanced Alcohol and Drug Counselor (CAADC) through the Michigan Certification Board for Addiction Professionals (MCBAP) within 30 days of hire, unless currently certified as a CCDP-D, CAADC, Certified Alcohol and Drug Counselor (CCADC), or a current Development Plan for CCDP-D or CAADC with MCBAP. Essential Physical Demands: Vision - Position requires the ability to visually assess details at both near and far distances, as well as to perceive depth and spatial relationships with or without reasonable accommodations. Hearing - Position requires the ability to receive and respond to verbal communication with or without reasonable accommodations. Lifting, Standing, and Walking With or Without Reasonable Accommodations: Position requires the ability to lift up to 35lbs on an occasional basis Position requires the ability to regularly stand for extended periods of time Position requires the ability to walk at a minimum of 35% up to a maximum of 65% Position will require the ability to occasionally stoop, bend, or reach to perform work tasks with or without reasonable accommodation Position must be able to perform tasks requiring manual dexterity, including the use of hands and fingers for handling, grasping, typing, writing, or operating equipment with or without reasonable accommodation. Veterans must submit Form DD214 to determine eligibility for Veterans' Preference Interested applicants must clearly show they meet the minimum qualifications. Resume must include the following information: Name of employer, month/year you were hired, month/year you left, if the position was part-time or full-time, and the job duties you performed while in the position. BARGAINING UNIT: Teamsters FLSA STATUS: NON-EXEMPT

Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site. Key ResponsibilitiesEssential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to: Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol: Assists with the basic screening of patients for study enrollment; Assists with patient follow-up visits; Documents in source clinic charts; Enters data in EDC and answers queries; Obtains vital signs and ECGs; May perform blood draws; Perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Request and track medical record requests; Enters data in EDC and answers queries; Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed; Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner. Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed; Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and Perform all other duties as requested or assigned. Skills, Knowledge and ExpertiseMinimum Qualifications: A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is preferred. Bi-lingual (English / Spanish) proficiency is a plus. Required Skills: Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm). Must possess strong organizational skills and attention to detail. Well-developed written and verbal communication skills. Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers. Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities. Must be professional, respectful of others, self-motivated, and have a strong work ethic. Must possess a high degree of integrity and dependability. Ability to work under minimal supervision, identify problems and implement solutions. Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines. Benefits Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.

Clinical Coordinator - Observation Unit - FT Evenings 12 pm - 10 pm no weekends * Department: Observation Unit * Schedule: Full Time Evenings 12 pm - 10:00 pm Monday - Friday and no weekends * Hospital: Henry Ford Genesys GENERAL SUMMARY: * Under the direction of the Director or Manager of Unit, provides clinical support at the unit level including but not limited to: assisting with direct patient care as necessary, assisting with patient throughout hospital stay (admissions, discharges, transfers), assessing patient condition, completing clinical tasks (IV's, blood draws, etc.), responds to all clinical emergency situations and recognizes, resolves and reports immediate situations that jeopardizes patient rights, safety and/or customer service. * Coaches patient care unit staff in clinical practice, critical thinking and customer service skill development. Coordinates bed utilization within inpatient hospital patient care units. EXPERIENCE AND EDUCATION: * Baccalaureate degree in Nursing preferred. * Requires two to three years of relevant acute care nursing experience. * Must have excellent communication skills, strong facilitative interpersonal skills, and excellent problem solving skills. * Requires a Michigan Nursing License. * ACLS preferred but not required. * Health care provider certification (BCLS) required. PHYSICAL DEMANDS: Extensive walking, standing, lifting, pushing, and the like may be necessary. WORKING CONDITIONS: Works in a patient care environment with possible exposure to communicable disease or unpleasant patient care tasks. Occasional exposure to disgruntled/unsatisfied patients and/or their families. Additional Information * Organization: Henry Ford Health Genesys Hospital * Department: Observation Unit 001 * Shift: Evening Job * Union Code: Not Applicable

Are you looking to take your career to new heights with a leader in healthcare? SUNY Downstate Health Sciences University is one of the nation's leading metropolitan medical centers. As the only academic medical center in Brooklyn, we serve a large population that is among the most diverse in the world. We are also highly-ranked by Castle Connolly Medical, a healthcare rating company for consumers, among the top 5 leading U.S. medical schools for training doctors. Bargaining Unit: UUP Job Summary: The Department of Medical Education at SUNY Downstate Health Sciences University is seeking a full-time Clinical Experience Coordinator / Senior Staff Assistant. The primary responsibility of the Clinical Experience Coordinator for undergraduate medical education clinical (UME) experiences will be to oversee the planning, preparation and execution of longitudinal clinical experiences in the College of Medicine. This role includes the recruitment, development and retention of preceptors and oversight of various clinical experiences for medical students throughout the UME curriculum. As the duties are ever evolving, we are seeking someone with expertise in managing their time efficiently and independently, and with strong organizational skills. The coordinator will report to the Administrator and Associate Dean for Clinical Skills. Key Responsibilities * Preceptor Recruitment: * Under the guidance of the Associate Dean for Clinical Skills, develop and coordinate direct outreach to potential preceptors; recruit preceptors for incoming medical students. Create awareness of volunteer opportunities in the extended community. Lead development of materials and presentations to potential preceptors and student placement sites. Vet potential preceptors and visit sites as needed. Complete onboarding of new preceptors through various clinical departments and process faculty appointments. * Preceptor Development & Retention: * Coordinate the initiation of new preceptors. Assist in defining standards for preceptor roles. Ensure preceptors are knowledgeable of the course curriculum. Ensure agreements and insurance with off-campus sites remain current. Maintain communication with active preceptors. Coordinate preceptor retention activities (e.g. professional development-CME, recognition awards). Ensure participating preceptors receive promised benefits such as online library access, etc. * Coordinate CME credit process for participating preceptors with office of CME. * Preceptor Experience: * Match students to preceptors and oversee the day to-day activities of the students' experiences. * Coordinate student onboarding at participating sites by communicating with Medical Education offices at preceptor sites and meet with students to troubleshoot issues and concerns. * Proctor exams for undergraduate medical students and assist in the planning, organization and delivery of student assessment and logistics. * Clinical Skills Curriculum Delivery: * assist with the coordination and implementation of other curricular events including student orientation, transition to clerkship, transition to residency, and faculty development sessions. * Under the guidance of the Administrator, provide logistical assistance and backup to other Clinical Skills staff throughout all Foundations 1 and 2 clinical skills curricula. * Monitor completion of Dean's Council for Education action plans by communicating with responsible parties. * Perform other job related duties as assigned.

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Join our growing Clinical Trials Unit (CTU) in Plymouth, MI, where we conduct innovative, high-impact clinical trials across expanding therapeutic areas. Since 2014, our collaborative team has thrived in a fast-paced environment focused on accuracy, participant safety, and operational excellence. We anticipate continued growth and offer opportunities for advancement to skilled Clinical Research Coordinators. This is a full-time position; however, part-time scheduling may be considered for highly qualified candidates. While most work will require on-site presence, there is opportunity to work 1 day remote dependent on project needs. Most shifts occur during daytime hours, though occasional evening, overnight, or weekend coverage may be required depending on study needs. Job Summary The Clinical Research Coordinator III (CRC III) is an advanced-level role responsible for independently coordinating complex clinical research studies from startup through closeout. This position requires strong clinical research knowledge, clinical trial experience, advanced protocol management skills, and the ability to support multiple studies simultaneously. The CRC III plays a critical role in participant recruitment, enrollment, visit execution, data management, and biospecimen handling while ensuring compliance with ICH-GCP, FDA, and sponsor requirements. The CRC III may also support regulatory submissions and serve as a resource to junior staff. Responsibilities Actively participates in participant recruitment, screening, informed consent, and enrollment. Coordinates complex study visits and procedures in accordance with protocol requirements. Oversees accurate data collection, source documentation, and entry into EDC systems. Performs data cleaning and resolves queries within sponsor-required timelines. Collects, processes, labels, stores, and ships biospecimens per laboratory manual specifications. Monitors participant safety, clinical status, and adverse events; ensures timely reporting. Ensures compliance with ICH-GCP, FDA, OHRP, HIPAA, and sponsor requirements. Manages regulatory components of studies, including maintaining the electronic Investigator Site File (eISF). Prepares for and participates in monitoring visits, SIVs, SQVs, and closeout visits. Provides mentorship and guidance to CRC I and CRC II team members. Participates in team meetings, investigator meetings, and sponsor-required trainings. Collaborates with investigators, clinicians, and research staff to support study execution. Assists in developing recruitment materials, source documents, and study tools. Maintains awareness of industry best practices and evolving research regulations. Qualifications Required Qualifications Bachelor's degree in health science, medical, or related discipline. 4-6 years of experience working with commercial clinical trials. BLS and/or ACLS certification. Proficiency with Microsoft Office and common EDC systems. Strong understanding of ICH-GCP, FDA, OHRP, and HIPAA regulations. Experience with biospecimen collection, processing, and shipping. Excellent organizational and problem-solving skills with ability to manage multiple studies. Strong communication and leadership ability. Ability to maintain strict confidentiality and data security. U.S. Citizenship or Permanent Residency required. Preferred Qualifications ACRP-CCRC or SOCRA certification. Extensive knowledge of medical terminology, clinical lab assessments, and pharmacovigilance. Experience with IRB processes and regulatory submission platforms (e.g., ePortal). Candidate Traits Highly detail-oriented with exceptional organizational skills. Strong leadership abilities with experience mentoring junior staff. Proactive problem solver with ability to work in a dynamic environment. Strong interpersonal skills and ability to collaborate with cross-disciplinary teams. Self-motivated and able to work independently while upholding ethical standards. The salary range is: $64,396-$82,400/annually. Salary ranges will vary and are based on several factors, including geographic location, market competitiveness and equity amongst internal employees in similar roles. Positions may also qualify for SRI's Pay for Outstanding Performance program or the annual Performance Based Compensation program. SRI also has a competitive benefits package, to view details please go to **************************************** SRI will accept applications until the position is filled. SRI is an independent nonprofit research institute headquartered in Menlo Park, Calif., with a rich history of supporting government and industry. We create and deliver world-changing solutions for a safer, healthier, and more sustainable future. For more than 75 years, we have collaborated across technical and scientific disciplines to discover and develop groundbreaking products and technologies and bring innovations and ideas to the marketplace.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Unique opportunity to make an Impact in the healthcare industry… Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, and Arizona. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials. As Revival Research Institute is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us. We are seeking International Medical Graduates with a minimum of 1 year of research experience. Additionally, someone with a strong interest in the Clinical Research field would be an excellent fit for our entry level position, with room to grow. However, this interest and background is not necessary, as our ideal candidate is an individual who is detail orientated, being able to maintain organized records, as well as someone who is motivated to learn new things, as our company is always growing and expanding into new therapeutic areas. We are looking for individuals that want the opportunity to learn and grow with us. New Staff should be genuinely respectful of diverse points-of-view and strive for an environment in which inclusiveness drives productivity and results. Some responsibilities will include coordinating and managing multiple studies. They are also responsible for assisting the Principal Investigators and other clinical staff, with any study related tasks as follows but not limited to: Research participant screening, recruitment and enrollment. Consent and conduct research visits for data collection/no risk trials or no study article/minimal risk trials with oversight. Responsible for collecting, processing and shipping of research specimens, where applicable. Document study related information in case report forms or electronic data capture systems, handles data queries and participates in monitoring visits. Obtain, review and maintain source documents. Maintain organization of all trial related documents and correspondence. Implement quality control and assurance methods. Communicate with study sponsors, research team and the Institutional Review Board. Assist with basic regulatory document preparation, with oversight e.g. study amendments, adverse event reporting, protocol deviation reporting. Maintain professional and technical knowledge of Clinical trials and Standards of Care. Protect patient confidentiality. Preferred Qualifications Education/ Training: International Medical Graduate; MBBS, BMBS, MBChC, MBBCh, MD, DO, MCM, DM, MCM, MMSc, MMedSc, MM, MMed, MS, MSurg, MChir, MCh, ChM, CM, MSc, DCM, DClinSurg, DMSc, DMedSc, DS, DSurg Radiology experience is preferred. Phlebotomy skills are also preferred. Additional Qualifications: Database and computer skills: Microsoft Office (Word, Excel), Outlook, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. Maintain data integrity within the department. Must be able to work in a team consisting of physicians, nurses, technicians, secretarial staff and ancillary hospital staff. Knowledge of FDA Regulations and Good Clinical Practices. JOIN US & GROW YOUR KNOWLEDGE & EXPERIENCE!!!