Clinical Research Manager Work From Home jobs

At Alcedis, you will be part of our mission to accelerate the adoption of digital and AI across research & care. As a trusted partner to biotechs, pharma, and academia, we integrate cutting-edge technology into clinical trials to advance drug development and patient care. Join us, and bring your expertise, passion, creativity and strong willingness for success to realize this mission. We are looking for a Clinical Project Manager to support our clinical operations department in the management of (interventional/non-interventional) clinical studies in the U.S.. This is a 100% remote position, but we are looking for candidates based on the U.S. East Coast, ideally in or around major metropolitan areas such as Boston, New York City, Philadelphia, or Washington, D.C. Other East Coast locations will also be considered. Travel is not primarily planned but may be a necessary option within a project and cannot be ruled out. You will be responsible for clinical study activities and will be in close contact with the clinical operations team at Alcedis, Germany to establish the location in the United States. Responsibilities Oversee project planning and execution, including study start-up activities, ongoing study management, and coordination at all stages of the clinical trial lifecycle Manage regulatory notifications and approval processes, ensuring submission of applications in compliance with national requirements Monitor project timelines and ensure adherence to the Project Plan, maintaining compliance with study objectives Project budget responsibility and project budget controlling, reporting to the functional unit head Develop and implement processes, SOPs, work instructions, and standardized documentation to ensure consistency and compliance Creation and management of study documents (e.g., Trial Master File) and preparation of trials (site contract management, creation of print materials, organization of trial material, organization of trial meetings, etc.) Supervise and coordinate trial sites, including communication, training, document shipping and tracking, and payment processing Coordination of monitoring activities, including review of monitoring reports Supervision and coordination of subcontractor activities Coordination of the project team across the various functional units and national borders (USA-Germany) Qualifications and requirements From day one, we expect you to bring: A Bachelor's degree in natural sciences, a related field, or an equivalent qualification-ideally with a medical focus; an advanced degree is preferred A minimum of 5 years of experience in clinical research, monitoring, or project management within the pharmaceutical, biotech, or CRO industry Hands-on experience with IRB/ethics committee submissions, as well as knowledge of data privacy and protection regulations Strong working knowledge of GCP/ICH guidelines, principles of observational research, FDA regulations, and HIPAA compliance An analytical, solution-oriented, and accountable approach to work Proficiency in working with electronic data and databases, along with solid skills in Microsoft Office applications Strong interpersonal skills and a collaborative team mindset The ability to work independently, proactively, and with strong planning and execution skills Excellent communication and organizational skills Fluency in English, both written and spoken What we can offer you $80,000 - $95,000 a year 15 paid vacation days Health, dental and vision insurance for you and your dependents Employee life insurance Health Savings Account (HSA) 401(K) You'll work in a future-oriented and secure working environment You can expect exciting and challenging projects With us you will find flat hierarchies combined with an open corporate culture You can expect a successful, committed and open team You'll enjoy a varied role with the autonomy to work independently and take responsibility for your projects We value a pleasant working atmosphere in a successful and growing company Flexible working hours are an integral part of our work culture At Alcedis, we believe that diversity and inclusion drive innovation and success. We welcome applicants of all backgrounds and do not discriminate based on race, ethnicity, gender, sexual orientation, disability, age, religion, or any other protected characteristic. Contact Come join us! Take the next step and apply today - we can't wait to meet you! To apply, please submit your resume and a short cover letter directly through the link or alternatively via our careers page: Career | Alcedis For more information about our company, please visit our website at Alcedis | Digital Clinical Trials

We are looking for a clinical researcher to join our team to train AI models. You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of each model. In this role you will need to hold an expert understanding of clinical research topics- a completed or in progress Masters/PhD is preferred but not required. Other related fields include, but are not limited to: Epidemiology, Biostatistics, Regulatory Affairs, Medical Ethics, Clinical Pharmacology, Health Economics, Translational Medicine, Nursing, Public Health. Benefits: * This is a full-time or part-time REMOTE position * You'll be able to choose which projects you want to work on * You can work on your own schedule * Projects are paid hourly starting at $40+ USDper hour, with bonuses on high-quality and high-volume work Responsibilities: * Give AI chatbots diverse and complex problems and evaluate their outputs * Evaluate the quality produced by AI models for correctness and performance Qualifications: * Fluency in English (native or bilingual level) * Detail-oriented * Proficient in inductive/deductive reasoning, research methods, data analysis * A current, in progress, or completed Masters and/or PhD is preferred but not required Note: Payment is made via PayPal. We will never ask for any money from you. #INDUSBIO Job Types: Full-time, Part-time Pay: From $40.00 per hour Expected hours: 1 - 40 per week Work Location: Remote

Entry Level Hybrid Research Coordinator Role in Chicago, IL (60612) We are hiring for an entry level Research Coordinator to join an exciting research site in the Chicagoland area. This position will be a 2 year long contract. Overall we are looking for a candidate that has some exposure to the research field that is passionate about making a positive impact as a Research Coordinator. Responsibilities: Communicate with patients Obtain required information and medical history Ensure patients have filled out the Online Questionnaire Data Collection Regulatory Responsibilities - Communicating with the IRB, attending meetings, providing data, etc. Confirming patients appointments/Assisting in scheduling patients Attend foundation meetings Ensure everyone on site is up to speed Additional Responsibilities as needed Details: Location: Chicago, IL (60612) Title: Research Coordinator Pay: $20/hr-$24/hr Hours: Monday-Friday; 9AM-4PM; Some flexibility to work remote Contract: 2 Year long contract

PSI is a leading Contract Research Organization with more than 29 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description Department /Resource Management and Training Line management of Site Contract Specialists in the North America and Latin America Oversees the workload and utilization of assigned staff in the region and allocates resources Monitors assigned staff performance and takes part in performance appraisal process Fosters career advancement of assigned staff Develops training materials, related to site agreement and budget processes, ensures training effectiveness Trains staff in matters related to site agreements and budgets Mentors and coaches Site Contract Specialists Operational Supervision, Quality Assurance and Process Improvement Oversees site agreements and budgets activities in the North America and Latin America Ensures that relevant parts of CTMS are up to date Identifies operational issues related to site agreements and budgets and works on their resolution Reviews country-specific fees schedule Oversees execution of site agreements and ensures acceleration opportunities are identified and taken Reviews and analyses key performance indicators and implements improvement plans Cooperates with other PSI functions on improvement of site agreement and budget processes Develops and updates QSDs, instructions and user guides relevant to site agreement and budgets and provides local expertise and best practices to other PSI functions and clients Participates in process improvement initiatives Qualifications College or University degree or an equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities. Equivalency is defined as a minimum of 2 years' experience in a health care or clinical environment, where relevant experience has been gained in clinical trials. At least 4 years' experience in clinical research and in site agreement and budget negotiation in the country/region Experience in people management, mentoring and leadership Additional Information If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. Organizational Overview: Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease. The Role: In collaboration with a therapeutic area VP of Clinical Development, the Clinical Research Scientist (CRS) will contribute to the design, conduct, analysis, and reporting of clinical trials. The CRS will apply scientific training and clinical research experience to support all aspects of drug development, from facilitating the transition of molecules from pre-clinical discovery to supporting the registration and commercialization of a product. Key Responsibilities: Contribute to the review, interpretation, and communication of scientific data pertaining to the efficacy and safety of compounds in development Effectively collaborate with the VP clinical development, the clinical trial manager and the clinical operations manager on all aspects of clinical study development from start to finish Attend congresses and review literature to develop and augment expertise in their specific therapeutic area Help develop program strategy including the clinical development plan, product lifecycle plans, target product profiles and draft labels. Review competitive landscape and help identify and evaluate business development opportunities Have responsibility for providing focused scientific and clinical study support from start-up to clinical study report (CSR) and publications. Participate in scientific education of internal and external stakeholders on the pre-clinical (e.g. mechanism of action, animal models) and clinical (e.g. epidemiology, diagnosis, treatment) data relevant to the program Engage opinion leader interactions to build pipeline awareness and foster research collaborations Contribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents Contribute to creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study conduct Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial, and medical education strategy for late-stage assets Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Contributes to authorship of regulatory responses and may participate in meetings Requirements: Advanced degree in Sciences required (e.g. M.S., PharmD, PhD or equivalent) PhD, PharmD or equivalent and 7+ years of clinical trial experience in the pharmaceutical industry is preferred. (M.S. and 10 years of experience as a CRS in pharmaceutical industry) Ability to provide input and direction to clinical research with appropriate supervision Strong desire to collaborate in a cross-functional setting Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols Work Environment: Dynamic, interactive, fast-paced, and entrepreneurial environment Immunovant' s headquarters is located in New York City. The position is flexible for remote work. Domestic travel required (up to 10%) Salary range for posting$220,000—$230,000 USD Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • The Study Specialist will augment activities performed by existing study team members whether from client or client's preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables. • This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development. • Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety. Organizational Relationships: • Oversight by client Clinical Operations Study Team Lead • Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur • Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead) Primary Duties: • Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff • Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes • Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites • Point of escalation for clinically identified site related issues • Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee • Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support) • Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality • Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file • Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/Client • Completes assigned training as necessary, including general training requirements, SOPs, system and process related training, and protocol specific training. • Complies with all departmental objectives and metrics related to study execution • Attend/lead/facilitate meetings as requested (i.e. investigator, project) to gain and/or share project/site knowledge Secondary Duties • As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site close-out activities for assigned clinical research sites with designated project SOPs, Client expectations, study specific protocol and GCPs • As needed, supports activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution • Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the study • Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan Training and Education Preferred: • Bachelor's Degree in Life Science, RN preferred • Minimum 5 years of study management experience with preferred focus in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring • Expertise in study start up and site management (experience in complex hospital-based Phase 3 clinical trials highly desirable) • Demonstrated ability to problem solve and to prioritize site related activities • Demonstrates solid understanding of drug development and clinical practices • Understands and is able to comprehend study protocols • Has knowledge of FDA regulations • Possesses working knowledge of GCPs and other regulations governing clinical research • Demonstrates technical expertise in computer skills • Demonstrates diligent and self-motivated approach to working in an independent environment • Demonstrates effective oral and written communication skills • Travel anticipated at 25% but could up to 50% at times. Qualifications BS/MS Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960

Job Title: Senior Clinical Trial Specialist (Remote) Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Employer Industry: Medical Device and Clinical Research Why Consider This Job Opportunity Salary up to $186,700 plus bonus eligible and benefits Opportunity for career advancement and growth within the organization Work remotely anywhere within the United States, with a preference for Eastern time zone Supportive and collaborative work environment Chance to make a positive impact on patient outcomes in the field of stroke therapies What To Expect (Job Responsibilities) Provide high-quality site monitoring and management for the Study Operations team within Clinical Shared Services Proactively communicate with investigators, colleagues, and vendors to ensure clinical quality and compliance Conduct clinical research activities in accordance with applicable regulations and guidelines Manage overall clinical site activities and provide oversight to Clinical Research Associates (CRAs) Develop and implement enrollment and recruitment strategies for clinical studies What Is Required (Qualifications) Bachelor's Degree in a health/science field (RN, BSN, MBBS, DPharm) 4 years of industry experience in a clinical study operations role within Medical Device or Pharma 3 years of independent site management responsibilities and data monitoring experience Demonstrated independence in conducting Site Qualification and Site Initiation Visits Working knowledge of GCP/ICH guidelines and federal/local regulations How To Stand Out (Preferred Qualifications) Master's, MBA, or PhD Experience performing Site Close-Out Visits ACRP CCRA Certification or SOCRA CCRP Category 3 Certification Medical Device monitoring experience Global clinical trial experience and EUMDR working knowledge #MedicalDevices #ClinicalResearch #RemoteWork #CareerOpportunity #CompetitivePay Talentify helps candidates around the world to discover and stay focused on the jobs they want until they can complete a full application in the hiring company career page/ATS. Lifelancer ( ********************** ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. For more details and to find similar roles, please check out the below Lifelancer link. **********************/jobs/view/310c8bd348198d1e464de6f77dd1258c

Clinical Scientist (Remote - US) Responsibilities: * You will have key relationships internally with clinical project (study) team, and other study stakeholders * Review the scientific data and develop product knowledge to understand and communicate the relevant information for one or more clinical studies * Develop and review various study protocols with minimal guidance including writing, reviewing, adjudication/resolution of cross functional comments, and ensuring a high-quality final document * Prepare and present the reports and presentations on the various findings of the clinical research * Regularly review the information to check safety procedures, efficiency, and the lab data accuracy and correctness * Review and validate clinical study reports (CSRs) with a thorough understanding of the connection between the data and the CSR * Contribute to, coordinate, and review regulatory documents, Consent Forms (ICF), and other relevant study materials * Collaborate with all study team members including Clinical/Medical Affairs, Clinical Operations, Drug Safety, Regulatory Affairs and external vendors * Meet deadlines and milestones required based upon assigned study goals * May be asked to participate in protocol design, writing and implementation to meet GCP, ICH and regulatory requirements * May be asked to provide input into the drug development and evidence generation process as a technical expert * 80% of the role will be data review Additional Skills & Qualifications: * Completion of PharmD, PhD, MD, MS, PA, NP, or equivalent education and experience * Experience in oncology and solid tumors * Phase 1/early phase experience * Must have 5 years of data review experience, 3+ within oncology * Proficiency in study design, con med, and lab review * Proficient knowledge and skills to support program-specific data review, trend identification, and data interpretation * Proficiency in medical terminology and medical writing skills * Knowledge of ICH, GCP, and other relevant regulatory guidelines * Proven ability to analyze clinical information succinctly and efficiently * Strong written communication skills, especially in developing clinical protocols, assessing data quality, and presenting trial results * Strong communication, presentation, analytic, and strategic capabilities * Ability to effectively collaborate with medical experts * Ability to collaborate with all levels of management in a cross-functional team environment Pay and Benefits The pay range for this position is $90.00 - $95.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Mar 21, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: * Hiring diverse talent * Maintaining an inclusive environment through persistent self-reflection * Building a culture of care, engagement, and recognition with clear outcomes * Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion, a leader in clinical research, is seeking a full-time Clinical Research Associate (CRA) Team Lead, to oversee monitoring and site management activities for clinical trials, clinical investigations and other interventional or non-interventional studies. This person will need to live within a few hours of our Tempe, Arizona location. Essential FunctionsTeam Leadership and Line ManagementProvide experienced leadership to a team of Clinical Research Associates involved in clinical studies that are executed at the sites conducting clinical research studies This includes, but is not limited to:•Direct supervision / line management of CRA staff and contractors in the team in accordance with Celerion policies and applicable regulations.•Interview, hire, and conduct onboarding training for new staff in conjunction with Human Resources; ensure that staff has the proper materials, systems access and training to complete job responsibilities.•Prepare and implement function specific training programs; ensure training on and adherence to Celerion's procedures and guidance documents, best business practices, legal and confidentiality constraints.•Assign staff members to clinical projects, monitor staff workload, and liaise with the Manager of Monitoring, GCD North America (as needed) to ensure appropriate allocation of resources and optimal utilization.•Ensure timely submission of timesheets and expense reports by staff as well as review/approve timesheets and expense reports in a timely manner.•Develop, mentor, manage and coach CRA staff to progress their skills so that the organization's quality standards are maintained.•Perform annual appraisals, define the performance objectives and advocate individual career development, responsibility and accountability•Serve as escalation line for direct reports, including trouble shooting, issue escalation, deviation management, QI/CAPA management•Advocate for the needs of the staff with other functions of the organization•Generate action plans and provide developmental/strategic oversight to optimize monitoring services, with a focus on high quality delivery of individual/team/departmental goals•Maintain a positive, results oriented work environment, build partnerships, model teamwork, and communicate in an open, balanced, and objective manner•Contribute to Process Improvement initiatives for Line of Service (LOS) Project related responsibilities Support day-to-day execution of monitoring services for the ongoing projects; ensure deliverable of the CRAs assigned to the projects are met on time within quality and budget parameters according to the Sponsor/Client expectations. This includes, but is not limited to:•Implementation and monitoring of clinical studies to ensure sponsor and investigator obligations are being met in compliance with local regulatory requirements, Good Clinical Practice, and the respective protocol or investigational plan as follows: -Ensure monitoring activities are occurring according to contract, monitoring plan and SOPs -Oversee and assist with monitoring plan and study material development (SIV Slides, SQV Waivers, etc.) -Co-monitor as needed -Update and review of clinical trial management tracking systems (CTMS) -Manage all monitoring activities within CTMS (visits, open and closed queries, issues opened) -Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings/training with pertinent departments and other vendors -Review monitoring metrics/deliverables to evaluate quality trends and compliance to monitoring plan•Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary;•Interact with Clinical Project Manager/designate and other study team members to ensure timely resolution of project study issues•Participate and demonstrate proactive involvement in project study meetings, internal project study meetings, and other activities enhancing project progress•Participate in audits and inspections, including preparation and follow-up activities as needed•Support Sponsor/Client in fulfilling their obligations with regard to submissions according to relevant regulatory requirements.•May act as a CRA for selected studies where needed and defined Additional Responsibilities•Perform on-site and in-house tasks according to contractual agreements with Sponsor/Client•Be thoroughly familiar with and follow all applicable procedures and policies (standard and study specific)•Interact with direct supervisor and the study team to develop a thorough and unambiguous understanding of all tasks required as well as project study timelines and priorities•Maintain a working knowledge of all required Celerion IT systems•Follow administrative and reporting/documentation requirements of Celerion and clients , as necessary•Agree to be subjected to audits, compliance, and performance reviews by Quality Assurance (QA) and Line of Service (LOS) associates•Perform other duties as assigned Requirements and Qualifications:•Bachelor's degree in a biomedical-related field, life sciences or equivalent field;•At least 5 years or more in clinical operations or related discipline either in CRO or Pharmaceutical industry with a minimum of 3 years onsite monitoring experience•People Management skills preferred;•Excellent oral and written communication skills in English;•High level of organization, multi-tasking, judgement , and analytical skills;•Good time management skills to ensure adherence to timelines;•Profound knowledge of Good Clinical Practice, 21 CRF Part 11, and other relevant regulatory requirements ;•Dedication to quality and reliability;•Commitment to continuous training and knowledge sharing; proactively keeping up to date with procedural industry standards and international regulatory developments in clinical research;•Ability to work well independently and as part of a team;•Self-motivation;•Maintain confidentiality of Subject data and Sponsor/Client information•Computer literate;•Strong attention to detail while being tactful and diplomatic.•Ability to conduct all types of site visits according to Celerion/Sponsor SOPs, GCP, and regulatory requirements;•Experience in performing Feasibilities, Site Qualification Visits, Initiation Visits, Investigational Product Accountability, Routine Monitoring Visits, Close Out Visits and in maintaining Trial Master Files and handling SAEs;•Flexible and willing to drive to the Tempe, Arizona site without much advanced notice. Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Summary ABOUT ALIRA HEALTH At Alira Health, our mission is to enable healthcare transformation. Our team collaborates fully to understand every aspect of each client's organization from concept ideation to commercial realization; from innovation to implementation. We support our clients with a full spectrum of patient-centric data and tech-enabled services. Our clients are global, and so are we. Our local presence and global collaboration allow us to deliver actionable business insights and an unmatched continuum of support across the full corporate and product lifecycle. We operate across thirteen offices located in Boston and San Francisco in the US; Barcelona, Basel, Bologna, Geneva, Milan, Munich, Paris and Verona in Europe; Cambridge, United Kingdom; Sydney, Australia; and Toronto, Canada. Job Description THE IN-HOUSE CLINICAL RESEARCH ASSOCIATE (CRA) ROLE The In-house CRA is an important member of the Alira Health Clinical team. In-house CRAs manage and support clinical sites from site approval through close-out. In-house CRAs work closely with field CRAs and Clinical Project Managers to ensure the integrity of the trial data without the need for frequent travel. ESSENTIAL JOB FUNCTIONS* • Develops study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), site binder contents, etc. • Supports sites in obtaining IRB approval, developing submission materials, and creating site-specific ICFs • Responds to sites' regulatory board requests for protocol and ICF clarification as needed • Ensures all required site regulatory documents and approvals are in place prior to investigational product shipment • Ensures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviews • Analyzes site performance problems (protocol adherence) and identifies solutions; provides ongoing training for study sites • Maintains regular communication with study sites to ensure protocol/GCP compliance, assesses subject accrual rates, and responds to sponsor requests • Conducts remote review of data entered on electronic Case Report Forms (eCRFs) • Works closely with field CRAs and data management to resolve queries on discrepant data • Assists with efforts to recruit investigative sites to participate in clinical studies • Complies with ICH GCP guidelines, FDA regulations, and company SOPs • Participates in internal, client/sponsor, scientific, and other meetings as required • Manages and resolves conflicting priorities to deliver on commitments Performs additional duties as assigned PREPARATION, KNOWLEDGE, SKILLS & ABILITIES • BS/BA from an undergraduate program or equivalent experience • 1-2 years of experience in clinical research • Proven ability to be careful, thorough, and detail-oriented • Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment • Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills • Self-starter who thrives in a collaborative, yet less structured team environment • Ability to problem-solve unstructured or ambiguous challenges • Strong command of English, both written and verbal • Excellent communication and interpersonal skills with customer service orientation • Proficient with MS Office Suite, particularly Word and Excel • Permanent authorization to work in the U.S. WORKING CONDITIONS/PHYSICAL DEMANDS Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting up to 30 lbs. Languages English Education Bachelor of Arts (BA), Bachelor of Science (BS) Contract Type Regular

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy. SI-BONE is focused on helping patients in one of the most under-served, under-diagnosed, and under-treated areas in orthopedics, the sacroiliac (SI) joint. SI-BONE developed an innovative, patented implant to fuse the SI joint. The iFuse Implant System provides a less invasive alternative to traditional sacroiliac (SI) joint fusion surgery and has been used in over 90,000 procedures to date. We are a medical device company that is focused on improving the lives of patients with sacroiliac pelvic conditions. We are looking for people who are passionate about our mission and who are willing to work hard to achieve it. We are also looking for people who are: * Purpose-Driven: We are purpose-driven in a tireless pursuit of our mission for patients. * Agile: We work in a fast-paced environment and need to be able to learn and adapt to change quickly. * Creative: We embrace creativity, and we need people who are not afraid to challenge the status quo. * Team Players: We roll-up our sleeves and work together as one team to achieve our goals. Key Responsibilities: The Clinical Research Associate (CRA) plays a key role in the lifecycle of SI-BONE's clinical studies. The CRA manages clinical study sites and coordinates activities to ensure overall compliance with the protocol and clinical objectives. This includes clinical site monitoring, both remote and onsite, the goal of which is to ensure high-quality study data and maintain good site relations. The CRA is expected to maintain a high level of professional expertise by reading relevant literature, attending meetings, and collaborating with physician customers. The CRA is responsible for performing all duties in compliance with all applicable corporate policies and worldwide regulatory requirements as included in the scope of the SI-BONE Quality Manual. The employee must act and conduct company business in an honest, ethical and lawful manner, consistent with the company's policies and AdvaMed Code of Conduct. The company does not tolerate retaliation in connection with making good faith reports of suspected violations. Specific Responsibilities: * Conducts site qualification, initiation, interim monitoring, and close out visits. * Ensures high-quality data through remote and onsite monitoring, acting as the study protocol expert and key resource for site staff, while guiding them and resolving queries within agreed timelines. * Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness, reconciling it with the Trial Master File (TMF), and ensuring the site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. * Actively manages site compliance with the protocol including enrollment, follow up visits, timely and accurate data entry through frequent site review and communication. * Contributes to the preparation of study related documents including CRFs, ICF, clinical monitoring plan. * Understands therapeutic area for assigned clinical projects. * Supports the SI-BONE Quality System, adheres to company policies, and performs mandated trainings on time. Knowledge, Education and Experience: * Knowledge of medical terminology * Strong problem-solving skills * Basic understanding of summary statistics * Agile and able to change direction as needed * Ability to identify and solve problems independently * 2+ years clinical research experience, or advanced degree with experience working with nurses and physicians * Bachelor's degree in health science field preferred * Travel fluency Expertise and Attributes: * Self-starter is a must for this position * Friendly outgoing personality who can build trust and rapport with physicians and study coordinators * Organized and efficient, this person should be a true team player with excellent verbal and written communication skills. Writing sample (monitoring report and follow up letter) required for review * Knowledge and familiarity of applicable regulations/standards (e.g. ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971, ISO 14155) as required to perform the job function Salary range: $73,000 - $81,000. The compensation range for this position is specific to the location and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For additional information on the company or the products including risks and benefits, please visit ********************** We are aware of active recruitment scams using the SI-BONE name, in which individuals pose as our recruiters and post fake remote job openings and make fake job offers on the Internet. Please note, we will never make an offer of employment without conducting multiple rounds of interviews face-to-face using secure video-conferencing technology. We will never ask candidates to cash checks or make a payment in order to be considered for a position. SI-BONE only uses company email addresses, which contain "@si-bone.com" to communicate with candidates. If you believe you've been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency at *************************************************** learn how to report it.

As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities What will you be doing? Works on multiple trials within Oncology Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes • Mentors/coaches junior flex team Acts as Lead SM-training other SMs on study Develops site start up documents for studies including SIV agenda Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines) Represents LTMs or SMs on SMTs/meetings Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial Supports country budget development and/or contract negotiation in liaison with CCS colleagues Assists with ASV Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document. Interfaces - Primary/Other: Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials. Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.) Qualifications What do you need to have? Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences Must be located in Canada Will work on US trials remote monitoring only Have a minimum of 2 -3 years' experience in monitoring pharmaceutical industry clinical trials Have a minimum of 1-3 years' experience monitoring Oncology trials Knowledge of several therapeutic areas Analytical/risk-based monitoring experience is an asset Ability to actively drive patient recruitment strategies at assigned sites Ability to partner closely with investigator and site staff to meet all of our study timelines Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. To qualify, applicants must be legally authorized to work in Canada, and should not require, now or in the future, sponsorship for employment visa status. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: ************************************ At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. ***************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Not ready to apply? We get it! Click here to stay in touch for future opportunities, events and other happenings!

Join our CRA Team in Cincinnati, Ohio! The Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with PhD/Life Science backgrounds who want to explore the research field, travel the US, and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you! MEDPACE CRA TRAINING PROGRAM (PACE ) No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE Training Program, you will join other Professionals Achieving CRA Excellence: * PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA. * PACE will prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums. * To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process. WHY BECOME A CRA This role takes you on a journey through travel and excitement which will allow you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. The CRA position provides many other distinctive advantages including: * Dynamic working environment, with varying responsibilities day-to day * Expansive experience in multiple therapeutic areas * Work within a team of therapeutic and regulatory experts * Defined CRA promotion and growth ladder with potential for mentoring and management advancements * Competitive pay and many additional perks unmatched by other CROs (SEE BELOW). WE OFFER THE FOLLOWING * Competitive travel bonus; * Equity/Stock Option program; * Training completion and retention bonus; * Annual merit increases; * 401K matching; * The opportunity to work from home; * Flexible work hours across days within a week; * Retain airline reward miles and hotel reward points; * Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere; * In-house travel agents, reimbursement for airline club, and TSA pre-check; * Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more; * CRA training program (PACE ); * Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts; * In-house administrative support for all levels of CRAs; and * Opportunities to work with international team of CRAs. Responsibilities * Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; * Communication with the medical site staff including coordinators, clinical research physicians, and their site staff; * Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; * Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements; * On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward; * Verification that the investigator is enrolling only eligible subjects; * Regulatory document review; * Medical device and/or investigational product/drug accountability and inventory; * Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; * Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and * Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Qualifications * Must have a minimum of a Bachelor's degree in a health or life science related field; * Ability to travel 60-70% to locations nationwide is required, or less if remote/virtual visits required; * Must maintain a valid driver's license and the ability to drive to monitoring sites; * Minimum 1 year healthcare-related work experience preferred; * Proficient knowledge of Microsoft Office; * Strong communication and presentation skills; and * Must be detail-oriented and efficient in time management. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets

Site: The General Hospital Corporation At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve. At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare - people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds - to apply. Job Summary The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Associate/Clinical Research Coordinator. The Cancer Center Protocol Office is a centralized research office that supports clinical researchers in all disciplines within the Cancer Center. Our office promotes and facilitates clinical research by providing comprehensive services to physicians conducting clinical trials while ensuring compliance with all regulatory requirements. The Clinical Research Associate/Clinical Research Coordinator I (CRA/CRC I) works under general supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. The CRA/CRC I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA/CRC I will be trained on the institutional and federal regulations governing clinical research. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination. The position involves direct patient contact. Qualifications PRINCIPAL DUTIES AND RESPONSIBILITIES: All duties will be performed under general supervision by the Clinical Research Manager. The following clinical duties will be performed: * Assist clinical team in screening potential patients for study participation * Schedule all protocol required tests and procedures * Coordinate patient appointments with physicians, nurses, and all test areas * Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers * Prepare pre-visit communication for providers to ensure required assessments are completed and documented * Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation * Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition * Coordinate, obtain, process, and ship protocol required tissue samples * Ensure collection and processing (e.g. spin/separate/freeze) of all required correlative research blood samples with the coordination of the MGH Sample Processing Lab (SPL) * Obtain vital signs and perform EKGs as required for individual studies * Administer quality of life assessments as required for individual studies The following data management responsibilities will be performed: * Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria * Enroll patients as required by the study sponsor and internal enrollment monitor team * Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance * Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements. * Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations * Maintain research charts and/or electronic files for all enrolled patients * Ensure adequate source documentation is in place for all data reported * Resolve data queries issued by the sponsor * Obtain protocol clarifications from the study sponsor and communicate information to the research team * Schedule and prepare for monitoring visits with sponsors * Facilitate the request and shipment of archival pathology samples * Organize and prepare for internal and external audits * Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies The following regulatory duties may be performed: * Maintain and organize study specific regulatory binders * Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB * Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study * Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required * Submit Data and Safety Monitoring Reports * Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process * Collect, complete, and submit essential regulatory documents to various regulatory entities * Participate in monitoring visits and file all monitoring visit correspondence * Ensure appropriate documentation of delegation and training for all study staff members * Maintain screening and enrollment logs SKILLS/ABILITIES/COMPETENCIES REQUIRED: * Careful attention to detail * Good organizational skills * Ability to follow directions * Good communication skills * Computer literacy * Working knowledge of clinical research protocols * Ability to demonstrate respect and professionalism for subjects' rights and individual needs LICENSES, CERTIFICATIONS, and/or REGISTRATIONS (if applicable): * None Additional Job Details (if applicable) EDUCATION: * BA/BS degree required EXPERIENCE: * None SUPERVISORY RESPONSIBILITY (if applicable): supervised. * None FISCAL RESPONSIBILITY (if applicable): * None WORKING CONDITIONS: * Duties will be performed primarily on-site in ambulatory/clinical office setting * Components of the data/regulatory role may allow for remote work. Remote Type Onsite Work Location 55 Fruit Street EEO Statement: The General Hospital Corporation is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Career CategoryClinicalJob Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Clinical Research Sr Medical Scientist, Endocrinology - US, Remote Live What you will do Let's do this. Let's change the world. In this vital role you will support the design, assessment, and communication of clinical programs which support the global scientific/medical evidence plan. Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the clinical development program. Participate and provide clinical input into safety and regulatory interactions. Provide clinical/scientific input during the development and execution clinical trials. Review data from clinical trials related to medical monitoring, as well as support and address questions from sites and from investigators. As needed, provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols). Interpret clinical trial data and participate in safety assessments. Review and provide clinical scientific input to safety narratives. Initiate database analyses to support commercial/clinical objectives. Contribute to the preparation of clinical study reports and regulatory submissions. Support interactions with regulatory agencies if needed. Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by the GDL or delegee and help identify new clinical research opportunities. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications: Basic Qualifications: Doctorate degree and 2 years of experience in clinical trials implementation in obesity, diabetes, or metabolic diseases OR Master's degree and 4 years of experience in clinical trials implementation in in obesity, diabetes, or metabolic diseases OR Bachelor's degree and 6 years of experience in in clinical trials implementation in obesity, diabetes, or metabolic diseases OR Associate's degree and 10 years of experience in clinical trials implementation in obesity, diabetes, or metabolic diseases Preferred Qualifications: Accredited residency in Endocrinology, board certified or equivalent 2+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities MD preferred. Prior research in obesity, diabetes, or metabolic diseases preferred. An understanding of the scientific method and clinical applications based medical, scientific and practical rationale Familiarity with concepts of clinical research and clinical trial design and execution including biostatistics Familiarity with regulatory agency organization, guidelines, and practices Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication History of solving problems, especially in implementation of clinical trials while exhibiting superior judgment and balanced, realistic understanding of issues. Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $168,677. to $218,907. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #obesity . Salary Range 168,677.00 USD - 218,907.00 USD

This position supports the Oregon Alzheimer's Disease Research Center (OADRC), an NIH/NIA-funded Alzheimer's Disease Research Center (ADRC) and part of the Layton Aging & Alzheimer's Disease Center. Layton Center investigative teams contribute to national and international efforts to understand aging and research promising treatments for Alzheimer's disease and related disorders. Function/Duties of Position This position is primarily responsible for the coordination of neuroimaging-focused research studies. We are looking for someone who is highly organized, motivated, and able to communicate effectively and professionally (verbally and in writing) with study participants, staff, faculty and other departments at OHSU. Responsibilities: Work with coordinators of ongoing Layton center studies to recruit and enroll existing participants in neuroimaging studies Screen, consent, and enroll participants in research studies Prepare for and coordinate in-person study visits including scheduling participants and staff (physicians, assessors and others), clinic space, imaging and/or other appointments Accompany participants to study visits, ensuring their comfort and understanding of the study activities Perform phlebotomy (training provided as needed), process and ship blood samples Maintain documentation including study visit data entry, organization and maintenance of study documents and materials Work with Principal Investigators and/or other staff on reporting of study activities Assist with regulatory compliance Sr. CRA level: Conduct regulatory compliance activities including correspondence with the OHSU IRB related to study submissions, protocol modifications, and continuing reviews Assist with study start-up activities, including OHSU and central IRB submissions and other study logistics Perform all responsibilities under minimal supervision *Please include a cover letter with your application. Required Qualifications Education and Experience: Senior Clinical Research Assistant: Bachelor's Degree in relevant field AND 1 year of relevant experience OR Associate's AND 3 years of relevant experience OR 4 years of relevant experience OR Equivalent combination of training and experience Clinical Research Assistant 2: Bachelor's degree in relevant field OR Associate's Degree AND 2 years of relevant experience OR 3 years of relevant experience OR Equivalent combination of training and experience Job Related Knowledge, Skills and Abilities (Competencies): Working knowledge of scientific methods and human subjects research Intermediate or advanced knowledge of Word, Excel, Outlook, and other MS Office programs Demonstration of high level of attention to detail; self-starter; ability to prioritize work demands and manage time appropriately Demonstrated high level of organization and ability to efficiently manage multiple tasks Ability to speak and communicate clearly and demonstrate a high level of professionalism; ability to interact patiently and respectfully with elderly volunteers Able to perform the essential functions of the position with or without accommodation Must possess excellent written and verbal communication skills and be able to multi-task Preferred Qualifications Human subjects research experience Experience working with older adults Experience working with the African American community and/or other underrepresented groups Experience with phlebotomy/phlebotomy certification Additional Details Typical schedule: approximately 8am-5pm M-F; possible infrequent local travel. Work schedule may vary depending on job/study requirements. Minimal remote work possible based on study needs. Travel between locations including using the Portland Aerial Tram. May have regular exposure to noise, interruptions, human tissues/fluids and radiation. Ability to walk participants to various on-campus locations for study visits. Use videoconferencing equipment (headphones/camera). Able to sit at a computer without a break for 60 minutes. All are welcome Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at ************ or *************.

This position supports the Oregon Alzheimer's Disease Research Center (OADRC), an NIH/NIA-funded Alzheimer's Disease Research Center (ADRC) and part of the Layton Aging & Alzheimer's Disease Center. Layton Center investigative teams contribute to national and international efforts to understand aging and research promising treatments for Alzheimer's disease and related disorders. Function/Duties of Position This position is primarily responsible for the coordination of neuroimaging-focused research studies. We are looking for someone who is highly organized, motivated, and able to communicate effectively and professionally (verbally and in writing) with study participants, staff, faculty and other departments at OHSU. Responsibilities: * Work with coordinators of ongoing Layton center studies to recruit and enroll existing participants in neuroimaging studies * Screen, consent, and enroll participants in research studies * Prepare for and coordinate in-person study visits including scheduling participants and staff (physicians, assessors and others), clinic space, imaging and/or other appointments * Accompany participants to study visits, ensuring their comfort and understanding of the study activities * Perform phlebotomy (training provided as needed), process and ship blood samples * Maintain documentation including study visit data entry, organization and maintenance of study documents and materials * Work with Principal Investigators and/or other staff on reporting of study activities * Assist with regulatory compliance Sr. CRA level: * Conduct regulatory compliance activities including correspondence with the OHSU IRB related to study submissions, protocol modifications, and continuing reviews * Assist with study start-up activities, including OHSU and central IRB submissions and other study logistics * Perform all responsibilities under minimal supervision * Please include a cover letter with your application. Required Qualifications Education and Experience: Senior Clinical Research Assistant: Bachelor's Degree in relevant field AND 1 year of relevant experience OR Associate's AND 3 years of relevant experience OR 4 years of relevant experience OR Equivalent combination of training and experience Clinical Research Assistant 2: Bachelor's degree in relevant field OR Associate's Degree AND 2 years of relevant experience OR 3 years of relevant experience OR Equivalent combination of training and experience Job Related Knowledge, Skills and Abilities (Competencies): * Working knowledge of scientific methods and human subjects research * Intermediate or advanced knowledge of Word, Excel, Outlook, and other MS Office programs * Demonstration of high level of attention to detail; self-starter; ability to prioritize work demands and manage time appropriately * Demonstrated high level of organization and ability to efficiently manage multiple tasks * Ability to speak and communicate clearly and demonstrate a high level of professionalism; ability to interact patiently and respectfully with elderly volunteers * Able to perform the essential functions of the position with or without accommodation * Must possess excellent written and verbal communication skills and be able to multi-task Preferred Qualifications * Human subjects research experience * Experience working with older adults * Experience working with the African American community and/or other underrepresented groups * Experience with phlebotomy/phlebotomy certification Additional Details * Typical schedule: approximately 8am-5pm M-F; possible infrequent local travel. * Work schedule may vary depending on job/study requirements. * Minimal remote work possible based on study needs. * Travel between locations including using the Portland Aerial Tram. * May have regular exposure to noise, interruptions, human tissues/fluids and radiation. * Ability to walk participants to various on-campus locations for study visits. * Use videoconferencing equipment (headphones/camera). * Able to sit at a computer without a break for 60 minutes. All are welcome Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at ************ or *************.

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Hourly Rate: $20.00 - $22.00/hr Monday - Friday (AM Office Hours) Job Summary: Assist the Regulatory Specialists/Manager in maintaining clinical trial documents for submission to regulatory agencies in accordance to site SOPs, ICH, GCP, and FDA guidelines. SOPs (Standard Operating Procedures), ICH (International Council for Harmonization), GCP (Good Clinical Practices), and FDA (Food and Drug Administration). Essential Responsibilities and Duties: Complies with current protocols, site SOPs, GCPs, IRB (Institutional Review Board) and FDA guidelines. Uploads regulatory documents with RealTime eDOCs System and files is paper binders, as necessary. Prepares, obtains, organizes and maintains regulatory and training documents in various storage mediums. Tracks submissions and ensure timely filing of documents. Obtains CVs (Curriculum Vitae) of external Investigators and other contract personnel and their signatures for appropriate regulatory documents. Forwards revised copies of protocols, informed consents, and other pertinent study documents to appropriate staff. Assists in obtaining necessary signatures from investigators. Works closely with study sponsor/CRO and key clinical trial personnel on relevant regulatory document issues. Ensures Clinical Conductor regulatory information is current. Participates in team meetings and complies with training requirements. Assists sponsors/CRO's as needed. Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must be able to effectively communicate verbally and in writing. Minimum High School graduate or equivalent. Minimum of 1 years of related experience. Must be self-directed and able to work with minimal supervision. Able to take a flexible approach to shifting priorities. Motivated to work consistently in a fast paced and rapidly changing environment. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. Ability to work overtime, weekends, and/or holidays as needed. Ability to travel as needed. Remote work arrangement depending on location. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Job Details 206 W WHITE STREET - CHAMPAIGN, IL Fully Remote Part Time $16.00 HourlyDescription If you are a detail-oriented, self-motivated individual with excellent communication skills and a passion for clinical research, this role could be the perfect fit for you! As an RA, you will have the opportunity to make a meaningful contribution to the advancement of medical knowledge while building valuable skills in data collection, recruitment, and participant communication. You will work in a fast-paced, dynamic environment that requires flexibility, integrity, and a commitment to quality. JOB SUMMARY The Research Assistant (RA) plays a key role in clinical research by performing outreach to potential participants and/or collecting and entering data. As an RA, you will pre-screen charts for research, identify potential research participants, conduct preliminary telephone screenings, provide visit reminders, and recruit, schedule, and/or refer participants to the research team for enrollment into clinical research studies. Additionally, you will support the research team with data collection directly from participants via interviews, medical record reviews, and data entry from source to electronic data capture forms. This role requires adherence to ethical, regulatory, and privacy requirements/standards for the protection of confidentiality, privacy, and respect for persons. RESPONSIBILITIES Act as a liaison between the research team and potential participants, building rapport and empathy to understand their needs and concerns. Perform accurate and efficient data entry of source documents into case report forms, ensuring data quality and compliance with ethical and regulatory requirements. Collaborate with the research team, troubleshoot and resolve data and information issues, and contribute to process improvement initiatives. Utilize tools to identify potential study participants that meet eligibility criteria and conduct pre-screenings and appointment scheduling. Actively recruit participants for research studies according to the study-specific recruitment plan and script, demonstrating patience, communication skills, and adaptability. Adhere to established timelines and deliverables for data entry and participant outreach to keep the study on track. Support general administrative functions as required, including maintaining records and documents. Performs other duties and projects as assigned Qualifications QUALIFICATIONS High School Diploma or equivalent. Bachelor's Degree or equivalent experience preferred. Strong ability to work independently and meet deadlines with high accuracy. Proficient computer skills, including experience with a variety of software programs. Excellent organizational skills with strong attention to detail; capable of synthesizing information from multiple sources. Comfortable working for extended periods reviewing data on-screen and making outreach attempts via phone, email, and messaging platforms. Self-motivated and enjoys both collaborative and independent work in a dynamic, remote environment. Experience with chart abstraction preferred, with the ability to quickly analyze multiple document types to extract relevant data. Ability to coordinate and organize large amounts of information. Excellent verbal, written, and interpersonal communication skills. Proficiency with Microsoft Office. Demonstrated initiative to learn and expand skill sets. Passionate about communicating with people. Able to adapt quickly to changing responsibilities, workloads, and priorities. Ability to differentiate key enrollment criteria across different clinical research studies. English language proficiency required. WORKING CONDITIONS This job operates in a flexible, remote professional environment with little to no onsite visits to partner sites/clinics. This role routinely uses standard office equipment such as computers, phones, and online software for documenting work and progress. Flexibility in hours is allowed, but the employee must be available in four-hour increments between the waking hours of 9:30 a.m. to 6:30 p.m. Evening and weekend hours are available. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOPs, working guidelines, policies, etc. Innovo Research is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Innovo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Innovo Research will not tolerate discrimination or harassment based on any of these characteristics. In addition, Innovo will provide reasonable accommodations for qualified individuals with disabilities. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.