Clinical Research Coordinator jobs at M3 Global Research - 62 jobs

The NSABP Foundation has an opening for Clinical Research Associate - Level 3. This is a hybrid position located in Pittsburgh, PA requiring 3 days in the office and 2 days remote work. PURPOSE This role supports breast and colorectal cancer clinical trial operations and the primary deliverables of ensuring accrual to NSABP protocols, data integrity and regulatory compliance. The Clinical Research Associate, Level 3 role is one that includes responsibilities both as an individual contributor and leader. Leadership responsibilities focus online management of study monitors. ESSENTIAL FUNCTIONS Actively plans, executes and assesses performance of activities across the life span of study. Ensures timely study start-up. Examples include but are not limited to study timeline start-up development, site selection and Principal Investigator review. Assists with site activation requirements including ICF review, site access to study platforms and other needs as they arise. Facilitates daily or weekly team huddles to assess, plan, review and prioritize activities to ensure timely site activation, accrual, metrics review, compliance with CMP and other study requirements and audit prep. Completes required trainings with appropriate documentation. Develops relationships with site staff and NSABP monitors. Acts as a liaison for NSABP, site staff and external partners. Conducts weekly performance metrics review, identifies gaps and initiates contact with study monitor to review performance as needed. Examples include the number of queries, query resolution, source data verification, protocol deviation reporting and other study specific metrics. Responsible for providing regular metrics assessment to leadership team. Identifies key metrics with poor performance and develops an action plan to remediate the issue. Develops and implements recruitment strategies to ensure accrual targets are met. Ensures site initiation visits, interim monitoring visits and close out visits are compliant with the Clinical Monitoring Plan (CMP). Reviews and approves itineraries to ensure CMP compliance and associated expense reports. Follows Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP and ICH guidelines. Develops, writes and implements Study Start-Up Plans, Clinical Monitoring Plans, Roles and Responsibilities grids and other study-specific documents. Collaborates with clinical research organizations and centralized services such as laboratories. Collaborates with data management regarding CRF development and UAT testing. Acts as a resource to sites and investigators. Accompanies study monitors within 3 months of onboarding to confirm that the CMP is implemented accurately, and that PI/site needs are met. Reviews SIV and monitoring reports to ensure expected quality compliance standards are met. These include compliance with CMP, SOPs, WIs and training requirements. Supports study monitors with resolution of significant site issues. Performs other job-related duties as assigned. OTHER RESPONSIBILITIES Knowledge of randomized clinical trials principles and procedures. Knowledge of federal and state regulations and guidelines pertaining to the conduct of clinical trials. Knowledge of the infrastructure and operational characteristics of successful patient accrual related to site and study management. EXPERIENCE/SKILLS Bachelor's degree required. Prior CRA experience required. Research certification strongly preferred Prior experience at CRO strongly preferred. Familiarity with electronic TMF, EDC and CTMS systems required. Strong verbal, written and organizational skills with a team-oriented approach required. Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment. Proficiency in Microsoft Office Suite HYBRID POSITION This is a hybrid position consisting of 2 days of remote work (Wednesday and Friday) and 3 days onsite in our office in Pittsburgh, PA (Monday, Tuesday and Thursday). The NSABP Foundation, Inc. is an Equal Employment Opportunity and Affirmative Action Employer committed to the value of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, national origin, physical or mental disability, protected veterans, genetic information, and sexual orientation.

I'm working with a university, ranked in the top 100 of National Universities, to hire a Clinical Research Coordinator to their drug studies team. Contract Duration: 3 month contract with high potential to convert Pay Rate: $28-34/hr About this role: Coordinate recruitment and enrollment of research participants Establish and maintain databases of subjects Schedule and conduct study visits Collect and enter data; register subjects and study visits in OnCore Perform Epic research billing review Maintain an up to date regulatory binder Schedule and attend sponsor visits and prepare and submit IRB paperwork to ensure compliance with IRB regulations. Experience: Bachelor's degree in life science or health professions field and at least three years of directly related clinical research coordinator experience Experience with drug studies is nice to have Knowledge of FDA, IRB, Pennsylvania and related regulations Prior experience with IRB submissions both local and central is nice to have Prior Electronic Data Capture (eDC) data entry skills is nice to have Strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants Interested? Apply now!

Participant Management: Screens potential participants, explains study details, obtains informed consent, schedules visits, and acts as a primary contact for subjects. Administrative Oversight: Organizes study files, prepares and submits regulatory documents (like IRB submissions), manages study budgets, and maintains trial-specific logs. Protocol Adherence: Ensures the trial follows the specific scientific protocol, protecting data integrity and participant safety. Data & Documentation: Collects, organizes, and manages research data, including case reports and drug accountability records, often working with data management teams. Staff & Resource Coordination: Trains research staff, arranges study equipment, and communicates with laboratories and investigators. Ethical Compliance: Upholds ethical standards, ensuring patient rights and well-being are prioritized throughout the study.

Contributor to the profitable management of the clinical research business, consistent with company principles, strategies, and objectives. Accountable for the overall coordination, organization, and efficient implementation of clinical trials including management of regulatory, clinical operations, and line management of Project Managers and support roles. Performs diverse managerial responsibilities requiring considerable analysis, judgment, and detailed understanding of clinical research processes. Works closely with the Principal Investigator and Managing Partner to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and a regulatory perspective. In executing these position responsibilities, the Site Director is guided by Good Clinical Practices (GCP), International Committee on Harmonization (ICH) guidelines, and company standard operating procedures and policies. Key Activities: Planning and Management: Supports Managing Partner implementation of business plans for achieving the strategic and tactical goals and objectives of the line of business. Contributor to the business plan in collaboration with the PI and Managing Partner Contributor to the financial performance of the line of business. Enforce standardized policies, procedures, and performance metrics to ensure consistency and excellence in research operations, data management, and regulatory submissions and activities. Foster a culture of accountability, collaboration, and continuous learning. Study Operations: Manages all aspects of clinical research studies and related office operations. Interviews, supports hiring process trains, , and manages Clinical Research Coordinators, Assistant Clinical Research Coordinators, Data Entry Specialists, Psychometric Raters, and the Front Desk Office Coordinators and Specialists. Evaluate staff performance, identify growth opportunities, and ensure role clarity. Oversees day-to-day clinical research operations, including protocol implementation, data management, and regulatory submissions and oversight. Manages the processes of informed consent, subject visits, source document, Case Report Form and other document preparation and disposition. Completes study visits and pre-screening visits of participants as business needs dictate. Partner with PI, Managing Partner, and research staff to ensure successful execution of clinical trials and adherence to timelines and budgets. Proactively identify operational risks and implement mitigation strategies to safeguard research quality, compliance, and patient safety. Maintain readiness for sponsor and regulatory inspections, serving as subject matter expert on compliance and quality matters. Serve as Point of Contact for internal and external audits, monitor compliance trends, and implement corrective and preventative actions to uphold operational integrity. Subject Recruitment: Assists Managing Partner with the implementation of plans for recruiting subjects into each study. Includes coordination and oversight of site metrics Includes collaboration with recruitment department as designated by Managing Partner Regulatory Oversight: Oversees regulatory activities for all studies including timelines, personnel involved, and key activities. Responsible for delivery of regulatory activities and site level metrics. Ensures that studies are implemented in compliance with Good Clinical Practice (GCP) guidelines as promulgated by the Food and Drug Administration (FDA) and the International Conference on Harmonization (ICH). Skills Required: B.A. or B.S. required;. A minimum of 7 years of progressive clinical trial management experience is required including prior Clinical Research Coordinator experience and experience in line management and/or leading teams Excellent communication, interpersonal, and problem solving skills with proven track record of implementing quality improvement initiatives, training programs, and regulatory compliance strategies in clinical research settings. Understanding of Clinical Research Requirements:Demonstrated knowledge with clinical research study processes and requirements. Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines. Thoroughness and Accuracy: Able to collect, organize, interpret, and record detailed information as required by study sponsors and regulatory and review agencies. Communication: Able to communicate with direct reports, co-workers, sponsors, and others in a collaborative and courteous manner. Knowledgeable in clinical operations and project management. Management: Able to manage a staff of clinical professionals and create a productive, satisfying work environment. Independence: Demonstrates the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, this job description, and company policy. Adaptability: Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change. Computer Skills: Able to use standard office software, as well as proprietary applications unique to the clinical research industry and individual sponsoring organizations.

Coordinates with Principal Investigator to ensure that clinical research trials and activities are performed in accordance with the study protocol, FDA, GCP, ICH Guidelines. Participant pre-screening, recruitment and scheduling Complete protocol and trial system training Maintenance of regulatory documents Conducts or participates in the informed consent process and discussions with trial participants, including answering any questions related to the study. Conducting participant visits Ability to perform basic lab and clinical procedures per protocol, such as: blood specimen collection (phlebotomy), blood pressure, vitals, EKGs, centrifuge operation, storing and shipping of lab specimens, and accountability of specimens and notification of courier for specimen pick-up Entering data in the EDC and resolving all queries Updating and maintaining trial logs and participant charts

Clinical Research Coordinator I Client: Large Healthcare Organization Duration: 1-year contract - possibility of FTE conversion MUST RESIDE IN ASHEVILLE, NC OR NEARBY Position Summary: The Research Coordinator position is responsible for Coordinating multiple research protocols and serving as a liaison with local investigators and Sponsors. Under direct supervision, this individual will mature in their understanding of research operations and regulations in order to achieve a fundamental understanding of human subject research. Major Responsibilities: Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement” During your employment you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date. Performs routine operational activities for multiple research protocols Liaise between site research personnel, industry sponsors, and Supervisor Collaborates closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable Coordinates schedule of assessments from initial submission of feasibility until study closeout Reviews the study design and inclusion/exclusion criteria with physician and patient Ensures the protection of study patients by verifying informed consent procedures and adhering to protocol requirements Ensures the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data Creates study specific tools for source documentation when not provided by sponsor Collects, completes, and enters data into study specific case report forms or electronic data capture systems Generates and tracks drug shipments, device shipments, and supplies as needed Ensures timely and accurate data completion Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations Communicates all protocol-related issues to appropriate study personnel or manager Attends study specific on-site meetings, investigator meetings, conference calls and monthly CRC meetings, as required Reviews and responds to any monitoring and auditing findings Qualifications: Bachelor's degree - Required 1+ years of relevant experience - Required Phlebotomy - Required Certified Clinical Research Coordinator - Preferred

US Central, Clinical Research Associate, Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. CRA's must have Oncology experience, GVHD would be nice but not required. They should be willing to do dermatology if requested. What you will be doing * Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. * Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. * Collaborating with investigators and site staff to facilitate smooth study conduct. * Performing data review and resolution of queries to maintain high-quality clinical data. * Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile * Bachelor's degree in a scientific or healthcare-related field. * Minimum of 2 years of experience as a Clinical Research Associate. * In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. * Strong organizational and communication skills, with attention to detail. * Ability to work independently and collaboratively in a fast-paced environment. * Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license 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 maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here 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. Are you a current ICON Employee? Please click here to apply

Clinical Research Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing * Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. * Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. * Collaborating with investigators and site staff to facilitate smooth study conduct. * Performing data review and resolution of queries to maintain high-quality clinical data. * Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile * Bachelor's degree in a scientific or healthcare-related field. * Minimum of 2 years of experience as a Clinical Research Associate. * In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. * Strong organizational and communication skills, with attention to detail. * Ability to work independently and collaboratively in a fast-paced environment. * Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license 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 maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here 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. Are you a current ICON Employee? Please click here to apply

Clinical Research Associate (SOAR) Multi TA - Texas ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. What will you be doing? * Works on multiple trials within the Cross Therapeutic areas - Start up focus * Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements. * Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies. * Build strong relationships with site personnel to facilitate a smooth onboarding process. * Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs). * Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation. * Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process. * Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities. * Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones. * Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines. * Proactively identify and address any issues that may delay study initiation or affect trial deliverables. * Maintain precise documentation to ensure readiness for inspections. * Support sites during the activation phase until they achieve "Green Light" status for site opening. * Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met. * Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards. 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 Texas, near a major airport. * Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials * Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical 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 the United States, 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 maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here 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. Are you a current ICON Employee? Please click here to apply

We are seeking an Assistant Clinical Research Coordinator to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate. OID conducts ongoing, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses. Test specimens are collected from ongoing surveillance programs and from special investigations of febrile illnesses and pneumonia among military personnel or civilians (recruits, forces afloat, deployed forces, outbreaks of concern, and border populations). In addition to the utilization of portable, rapid assay technologies to identify pathogens in the field, test specimens and limited epidemiologic data, when approved by the Institutional Review Board (IRB), are provided to the NHRC laboratory where diagnostics and, in some instances, in-depth pathogen characterization are conducted. Results are provided to sponsors, the Armed Forces Health Surveillance Center, local investigators and collaborators, and, when applicable, county health units to guide proper responses that ultimately affect both the readiness of US forces and the safety of public health. CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs. Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad. Responsibilities Study Coordination and Protocol Management: Manages day-to-day operations of clinical research studies, ensuring adherence to study protocols and regulatory requirements. Coordinates the implementation of study protocols, including preparing and submitting protocol amendments and updates. Works with study investigators to ensure that research studies remain on schedule and meet target milestones. Participant Recruitment and Screening: Screens potential participants for eligibility according to study criteria. Obtains informed consent from study participants and explain study procedures in compliance with ethical standards. Coordinates and schedules study visits, ensuring participant adherence to study requirements. Sample Collection, Data Collection and Entry: Collects and accurately records study data, including patient information and study outcomes. Collects samples, per protocol. Enters and manages data in the study database, ensuring data integrity and compliance with Good Clinical Practice (GCP) standards. Assists with resolving data queries and discrepancies, working closely with study teams to ensure data accuracy. Patient Follow-Up and Monitoring: Conducts follow-up visits or calls to study participants, monitoring their progress and ensuring they remain engaged in the study. Reports any adverse events or changes in patient status to the appropriate study personnel. Database Management: Maintains the clinical trial database, ensuring that all study-related data is up to date and accessible for analysis. Assists with generating reports and summaries of study data for review by investigators and sponsors. Performs other duties as assigned. Qualifications Required Completion of at least two (2) years of college, with coursework in biological sciences, public health, or related fields. Strong organizational skills and attention to detail. Ability to work independently, manage multiple tasks, and prioritize effectively. Excellent interpersonal and communication skills, with the ability to work with patients and clinical staff. Proficiency in data entry and database management. US Citizenship and the ability to obtain and maintain a T3/Secret Clearance. Preferred Previous experience in clinical research or healthcare settings. Familiarity with clinical trial protocols, data collection, and patient recruitment. Knowledge of regulatory requirements for clinical trials, including IRB submissions and GCP standards. Physical Requirements: The physical requirements described here are representative of those that must be met by a candidate to perform the essential functions of this job. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential job functions. Constantly required to perform sedentary work that primarily involves sitting/standing. Occasionally required to perform light work that includes moving objects up to 20 pounds, and medium work that includes moving objects up to 50 pounds. Occasionally required to push or pull less than 25 pounds. Occasionally required to reach above shoulder level. Constantly required to use both hands. Occasionally required to stand or walk for more than 25 minutes. Occasionally required to bend, reach, or twist repeatedly, kneel, squat, or stoop, crawl or climb. Constantly required to have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity. Occasionally required to move self in different positions to accomplish tasks in various environments including tight and confined spaces. Occasionally required to move about to accomplish tasks or move from one worksite to another. Constantly required to communicate with others to exchange information. Occasionally required to operate machinery and/or power tools. Occasionally required to operate motor vehicles or heavy equipment. Constantly required to assess the accuracy, neatness and thoroughness of the work assigned. Occasionally required to work in low temperatures and high temperatures. Occasionally required to work in outdoor elements such as precipitation and wind, and to work in noisy environments. Occasionally required to work in hazardous conditions and in poor ventilation. Occasionally required to work in small and/or enclosed spaces and in environments where no adverse environmental conditions expected. Constantly required to wear PPE including but not limited to gloves, face shields/goggles, safety glasses, safety shoes, and lab coat. Occasionally required to wear disposable dust/surgical mask, respirators, such as a disposable respirator mask (N-95), half-face/full-face style, PAPR, SCUBA, and come in contact with chemicals, such as aerosols, biological inhalants, plastics, inorganic dust, and powders, etc. Please submit your resume online at ************** . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law. CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability. Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Client develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. Client provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Their ultimate goal is to help people live healthy lives. They have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. The Temperature Management Coordinator is responsible for day to day the execution management of the Temperature Management & Control for Clinical Supplies clinical supplies during the execution phase of clinical trials consistent with GMP guidelines with a specific focus on Temperature Management & Control of Clinical Supplies. This individual will follow standard operating procedures . Responsible for management of to all evaluate all temperature excursions associated to clinical supplies during the trial execution ensuring prompt resolution and compliance with all SOP, GMP, Quality, and Regulatory guidelines, contributing to successful subject dosing within Janssen Pharma R&D for all phases of clinical trials.. Act as a single point of contact accountable for the business critical need. Manage and adjust supply dispositions via inventory systems including IVR & IWR based on the outcome of the temperate out of range evaluation. Conduct issue resolution activities for the temperature excursion supply aspects of the clinical trials. This individual will Develop strong internal collaboration with collaborate with GCDO, DPD, and Quality stakeholders to ensure for TOR resolution and overall customer satisfaction. Interface with Global Trial Managers, Trial Supply Managers, Drug Product Development, and Quality to manage trial supply temperature excursions. Responsible for execution of Temperature Monitoring Coordinator role during trial feasibility and throughout trial execution driving robust temperature management within company for all phases of clinical trials. They conduct the Review and approval of all Investigational Site Temperature Management Equipment Questionnaire Approvals (TMEQ) for Cold Chain IMP. Act as subject matter experts for They serve as subject matter consultants on temperature management requirements including storage and monitoring capabilities. They Customizing customize protocol specific temperature out-of-range forms based on product attributes. Coordinating Obtain quotes request and complete PO setup process to centrally source temperature monitoring devices. Develop strong internal collaboration with GCO stakeholders to ensure customer satisfaction. Partner with Global Trial Managers, Local Trial Managers, Site Managers, Local Medication Coordinators, Clinical Supplies Design Leaders, and Central Business Operations in temperature management and issue resolution. Supports Contribute to business process improvement initiatives. Responsible for the Temperature Management & Control of all clinical supplies from feasibility throughout trial execution in company Qualifications A minimum of a High School Diploma is required . A Bachelor's Degree is preferred. Two years' experience in a multi-disciplinary environment or Pharma R&D area is highly preferred. Experience with quality system tools are preferred (e.g. Trackwise ). Experience with Interactive Response Technologies for Clinical Trials (e.g. inventory management functionality) is preferred. Experience with the following functions is preferred, clinical operations, logistics, quality assurance, clinical supply chain planning and drug product development. Demonstrated knowledge in Clinical Supply Distribution and Clinical Study execution /GCP is preferred. Intermediate to advanced software skills (e.g., Microsoft Excel, SharePoint, PowerPoint ) is required. Experience in a highly matrixed environment is preferred. Excellent written and verbal communication skills are required. Additional Information Kind Regards, Sasha Sharma 732-662-7964 Integrated Resources, Inc.

Science 37's mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; Direct-to- Patient Site and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration. The Clinical Research Coordinator II fulfills the requirements of recruiting, enrolling and conducting follow-up of study participants in clinical trials under the direct supervision of the Principal Investigator (PI) and Project Manager. In doing so, the Clinical Research Coordinator II is responsible for coordinating trial participation of study volunteers with the trial's protocol, company and trial Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.). The Clinical Research Coordinator II is responsible for working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol. DUTIES AND RESPONSIBILITIES Duties include but are not limited to: Actively participates in the implementation and execution of clinical trial activities from study start-up preparations, planning, execution and closure. Attends investigator, project and department meetings/trainings, leads as needed, and assists in gathering agenda topics and creating meeting minutes as required. Participates as temporary Project Manager for smaller studies, as needed, with appropriate training/support. Under direct supervision of a Principal Investigator, is responsible for enlisting, maintaining, and assuring protocol compliance for all study participants in clinical trials. Collaborates with study investigators in determining eligibility of potential participants in clinical trials. Screens potential participants for protocol eligibility. Presents trial concepts and details to the participant, participates in the informed consent process, and enrolls participants in study protocol. Ensures research quality by practicing in compliance with and advocating for any edit needs of Science 37 Standard Operating Procedures (SOP), and ensures research quality by practicing in compliance with principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. Supports the development, review and distribution of clinical protocols, informed consent forms, study instructions/manuals/guidelines or department generated tools and other study-related clinical documents. Coordinates patient care in compliance with protocol requirements. May provide participants education regarding medication administration. Maintains individual participant investigational drug accountability. In collaboration with the study investigator, reviews study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings. Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities. Maintains comprehensive knowledge of assigned research protocol to coordinate the comprehensive and compliant execution of assigned protocols in accordance with research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements. Ensures the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according to guidelines. Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives. Supports the maintenance of regulatory documents in the ISF in accordance with SOPs and applicable regulations. Participates in required training and education programs. Assists with education of other personnel and vendors regarding clinical research. Collaborates closely with Project Manager to ensure compliance to trial procedures and vendor management. Provides process improvement solutions and collaborates on the implementation of the solutions. Additional responsibilities may include working directly with other vendors and/or sponsors. Provides a safe environment for study participants, caregivers, and study personnel at all times through compliance with all federal, state, and professional regulatory standards. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Provides mentorship and training for other CRCs as needed. Provides assistance to and creates a supportive environment for the CRC team. DUTIES AND RESPONSIBILITIES FOR HYBRID TRIALS Acts as a point of contact for the site and Sponsor, as necessary, with oversight from the Project Manager. Develops project plan outlining planning, execution and closeout processes. Develops the study communication plan in collaboration with the sites. Collaborates with the Science 37 study team and extended members to ensure compliance to trial procedures. Collaborates with Science 37 multi-disciplinary teams to provide clear direction and processes for site study teams and assist with study execution. Other duties, as assigned. QUALIFICATIONS & SKILLS Qualifications The following qualifications are preferred and/or equivalent applicable experience: Bachelor's degree (preferred) or minimum two-year college degree, or an equivalent combination of education, training, experience, and demonstrated skills needed to successfully perform the assigned duties and responsibilities. Advanced degree preferred but not required. A minimum of 5 years of pharmaceutical-sponsored clinical research experience is required or commensurate education, training, and experience within the clinical research field. ACRP (CCRC) or SoCRA (CCRP) certification, highly desired Medical and scientific knowledge, preferred. Experience working with patients in a HIPAA regulated environment and knowledge of good clinical practice (GCP), and applicable regulatory requirements. Excellent time management, organizational skills and ability to manage multiple tasks. Attention to detail and accuracy in work. Must have the ability to conduct collaborative interaction with cross functional team members. Skills/Competencies Expertise in trial management - Demonstrated ability to successfully manage the participation of patients in clinical trials. Proactive problem-solving abilities and follow through. Expert Knowledge of FDA regulations and GCP guidelines - Understands applicable regulations and implications for trial participation. Expert knowledge of clinical research - Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive study participant rapport, project team members, and internal Science37 relationships. Ability to interact with patients and caregivers in a compassionate and empathetic manner. Leadership skills - Demonstrates the ability to communicate effectively across multifunctional teams. Provides effective solutions to challenges. Is recognized by others as a leader and a resource. Computer skills - Proficient with MS Office and Google Suite applications. Able to generate business correspondence, create forms and generate spreadsheet reports as required. Demonstrates expertise in the use of proprietary software. Practices professionalism and integrity in all actions - Demonstrates ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done. The ability to adapt to a rapidly changing work environment. Able to successfully work in a decentralized team environment. Skilled in situational responsive decision-making. Capabilities Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed Ability to communicate in English (both verbal and written) May require extended or unusual work hours based on research requirements and business needs. BENEFITS At Science 37, our focus is to provide you with a comprehensive and competitive total reward package that supports you at all stages of your career - both now and into the future. Our success depends on the knowledge, capabilities, and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work that adds to your professional development. Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. Submit your resume to apply! To learn about Science 37's privacy practices including compliance with applicable privacy laws, please click here

Clinical Research Coordinator - (25003181) Description Temple University's Lewis Katz School of Medicine Department of Nephrology/Ophthalmology is searching for a Clinical Research Coordinator!Become a part of the Temple family and you will have access to the following: Full medical, dental, vision coverage Paid time off 11 Paid Holidays Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE A generous retirement plan and so much more!Salary Grade: T25 Learn more about the “T” salary structure. Salary Range: $50,000 to $60,000A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. This role is also eligible for our employee referral program-TERP! Current employees can earn up to $500! Conditions apply. Please contact the HR Employment office for details. Job Summary: The Clinical Research Coordinator will work under the direct supervision of the Director, CRORA in collaboration with the Principal Investigators to provide research support requiring the application of standard clinical research practices. The Clinical Research Coordinator will be responsible for the planning, implementation, and execution of Clinical Trials for both the Department of Medicine/section of Nephrology and Ophthalmology departments at the Temple University Lewis Katz School of Medicine. Required Education and Experience: Bachelor's degree in life science or health professions field and at least three years of directly related clinical research coordinator experience. An equivalent combination of education and experience may be considered. Responsibilities: •Assist with screening, tracking and enrolling patients in active clinical trials•Obtaining informed consent•Scheduling and conducting study visits•Preparing IRB Submissions•Acting as the primary contact for study sponsors and participants•Processing and shipping laboratory specimens•Interacting with study sponsors, faculty and staff. •Collecting and entering study data into study databases. •schedule and participate in sponsor meetings, and resolve queries in a timely fashion•Assist with start-up activities for new studies including feasibility review and pre-start-up sponsor meeting Additional responsibilities include: •working independently to drive day to day research activities•supporting multiple active protocols simultaneously•supporting multiple active protocols simultaneously, assisting with investigator-initiated research•writing protocols, submitting studies to local and central IRBs, maintaining regulatory compliance and documentation, updating study records on clinicaltrials. gov•working with multiple investigators while adhering with FDA, IRB, Pennsylvania, and related regulations and Temple policies•Performs other duties as assigned Additional Information:•This is an onsite position on the Health Science Campus. There may be opportunities for a hybrid work arrangement depending on the department and the study-specific needs. •This position requires a background check•This position requires Child Abuse Certifications prior to the commencement of service Temple University values diversity and is committed to equal opportunity for all persons regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, sex, sexual orientation, veteran status, or any other status protected by law. Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Go here to review: *************** temple. edu/reports-logs/annual-security-report. You may request a copy of the report by calling Temple University's Department of Public Safety at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC) Job: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

Science 37's mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; Direct-to- Patient Site and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration. The Clinical Research Coordinator II fulfills the requirements of recruiting, enrolling and conducting follow-up of study participants in clinical trials under the direct supervision of the Principal Investigator (PI) and Project Manager. In doing so, the Clinical Research Coordinator II is responsible for coordinating trial participation of study volunteers with the trial's protocol, company and trial Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.). The Clinical Research Coordinator II is responsible for working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol. DUTIES AND RESPONSIBILITIES Duties include but are not limited to: * Actively participates in the implementation and execution of clinical trial activities from study start-up preparations, planning, execution and closure. * Attends investigator, project and department meetings/trainings, leads as needed, and assists in gathering agenda topics and creating meeting minutes as required. * Participates as temporary Project Manager for smaller studies, as needed, with appropriate training/support. * Under direct supervision of a Principal Investigator, is responsible for enlisting, maintaining, and assuring protocol compliance for all study participants in clinical trials. * Collaborates with study investigators in determining eligibility of potential participants in clinical trials. * Screens potential participants for protocol eligibility. Presents trial concepts and details to the participant, participates in the informed consent process, and enrolls participants in study protocol. * Ensures research quality by practicing in compliance with and advocating for any edit needs of Science 37 Standard Operating Procedures (SOP), and ensures research quality by practicing in compliance with principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. * Supports the development, review and distribution of clinical protocols, informed consent forms, study instructions/manuals/guidelines or department generated tools and other study-related clinical documents. * Coordinates patient care in compliance with protocol requirements. May provide participants education regarding medication administration. Maintains individual participant investigational drug accountability. * In collaboration with the study investigator, reviews study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings. * Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities. * Maintains comprehensive knowledge of assigned research protocol to coordinate the comprehensive and compliant execution of assigned protocols in accordance with research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements. * Ensures the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according to guidelines. * Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives. * Supports the maintenance of regulatory documents in the ISF in accordance with SOPs and applicable regulations. * Participates in required training and education programs. Assists with education of other personnel and vendors regarding clinical research. * Collaborates closely with Project Manager to ensure compliance to trial procedures and vendor management. * Provides process improvement solutions and collaborates on the implementation of the solutions. * Additional responsibilities may include working directly with other vendors and/or sponsors. * Provides a safe environment for study participants, caregivers, and study personnel at all times through compliance with all federal, state, and professional regulatory standards. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. * Provides mentorship and training for other CRCs as needed. * Provides assistance to and creates a supportive environment for the CRC team. DUTIES AND RESPONSIBILITIES FOR HYBRID TRIALS * Acts as a point of contact for the site and Sponsor, as necessary, with oversight from the Project Manager. * Develops project plan outlining planning, execution and closeout processes. * Develops the study communication plan in collaboration with the sites. * Collaborates with the Science 37 study team and extended members to ensure compliance to trial procedures. * Collaborates with Science 37 multi-disciplinary teams to provide clear direction and processes for site study teams and assist with study execution. * Other duties, as assigned. QUALIFICATIONS & SKILLS Qualifications The following qualifications are preferred and/or equivalent applicable experience: * Bachelor's degree (preferred) or minimum two-year college degree, or an equivalent combination of education, training, experience, and demonstrated skills needed to successfully perform the assigned duties and responsibilities. Advanced degree preferred but not required. * A minimum of 5 years of pharmaceutical-sponsored clinical research experience is required or commensurate education, training, and experience within the clinical research field. * ACRP (CCRC) or SoCRA (CCRP) certification, highly desired * Medical and scientific knowledge, preferred. * Experience working with patients in a HIPAA regulated environment and knowledge of good clinical practice (GCP), and applicable regulatory requirements. * Excellent time management, organizational skills and ability to manage multiple tasks. * Attention to detail and accuracy in work. * Must have the ability to conduct collaborative interaction with cross functional team members. Skills/Competencies * Expertise in trial management - Demonstrated ability to successfully manage the participation of patients in clinical trials. Proactive problem-solving abilities and follow through. * Expert Knowledge of FDA regulations and GCP guidelines - Understands applicable regulations and implications for trial participation. * Expert knowledge of clinical research - Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. * Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive study participant rapport, project team members, and internal Science37 relationships. Ability to interact with patients and caregivers in a compassionate and empathetic manner. * Leadership skills - Demonstrates the ability to communicate effectively across multifunctional teams. Provides effective solutions to challenges. Is recognized by others as a leader and a resource. * Computer skills - Proficient with MS Office and Google Suite applications. Able to generate business correspondence, create forms and generate spreadsheet reports as required. Demonstrates expertise in the use of proprietary software. * Practices professionalism and integrity in all actions - Demonstrates ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done. The ability to adapt to a rapidly changing work environment. Able to successfully work in a decentralized team environment. Skilled in situational responsive decision-making. Capabilities * Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed * Ability to communicate in English (both verbal and written) * May require extended or unusual work hours based on research requirements and business needs. BENEFITS At Science 37, our focus is to provide you with a comprehensive and competitive total reward package that supports you at all stages of your career - both now and into the future. Our success depends on the knowledge, capabilities, and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work that adds to your professional development. Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. Submit your resume to apply!

Clinical Research Coordinator-Pool - (25003464) Description Temple University's Clinical Research Department is searching for a Clinical Research Coordinator to join our team!Become a part of the Temple family and you will have access to the following: Full medical, dental, vision coverage Paid time off 11 Paid Holidays Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE A generous retirement plan and so much more!Salary Grade: T25Learn more about the “T” salary structure Salary Range: $50,000 to $55,000A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. This role is also eligible for our employee referral program-TERP! Current employees can earn up to $500! Conditions apply. Please contact the HR Employment office for details. Job Details:*This is a grant-funded position*This position requires the following background checks: Cash Handling *Clinical Research Coordinators may be hired for a specific department or as a pooled coordinator. *Hybrid work options may be considered depending on study and departmental needs. Position Summary: The Clinical Research Coordinator works under the leadership of the Principal Investigator and/or other Research Staff and is responsible for specific research tasks associated with clinical research projects or clinical trials, ensuring high-quality data collection, regulatory compliance, and seamless study operations. As a Clinical Research Coordinator, you will also have the opportunity to advance your career through our structured step increase program. We also recognize and reward professional development. Coordinators who successfully earn industry-recognized certifications, such as the Certified Clinical Research Professional (CCRP ) through SOCRA or the Certified Clinical Research Coordinator (CCRC ) through ACRP, may qualify for advancement sooner. At Temple University's Lewis Katz School of Medicine, you will be part of a nationally recognized, state-of-the-art research community that is driving innovation in patient care. Our clinical research programs span a wide range of disciplines and provide coordinators with the opportunity to contribute to groundbreaking studies that directly impact the health and well-being of diverse populations. With access to advanced resources, collaborative teams, and a strong commitment to excellence, Temple offers an ideal environment for Clinical Research Coordinators to grow their careers while shaping the future of medicine. Required Education and Experience: Bachelor's degree in a life science or other health professions field*A minimum of three years of related experience *An equivalent combination of education and experience may be considered. Responsibilities:The Clinical Research Coordinator performs study coordination tasks independently, following established protocols and procedures. The coordinator makes decisions that require interpretation of policies, procedures, or instructions to ensure accurate and compliant execution of clinical research projects. *Oversees the day-to-day activities of all assigned research projects and clinical trials. *Screens, tracks, and enrolls patients in clinical trials and other research studies for the Lewis Katz School of Medicine at Temple University. Schedule and attend sponsor visits. *Enrolls human subjects for clinical trials. Obtains informed consent, schedules subjects for visits, performs clinical assessments and collects and enters study data. *Performs various research, database, and clerical tasks to support clinical trials, aiding investigators in organizing, gathering, and compiling clinical research data. *Organizes and maintains documentation required for clinical trials and/or other research projects. Maintains up-to-date regulatory binders. *Inform the Principal Investigator or designated individual about any issues regarding patient responses to treatment, medication, or adverse effects. *May submit IRB paperwork to ensure compliance with IRB regulations. *Assist the Principal Investigator with Institutional Review Board (IRB) filings and annual reviews. *Offer clerical and technical support to ensure adherence to research protocols and maintain the quality of information received. *May prepare, review, and submit IRB and regulatory paperwork, ensuring full compliance with institutional, FDA, IRB, and state requirements; supports complex filings and amendments. Adheres with FDA, IRB, Pennsylvania, and other applicable regulations. *Performs other duties as assigned*May present project updates at clinical research meetings and/or assist with grant or manuscript preparation. Performs other duties as assigned Required Skills and Abilities:*Demonstrated computer skills, and proficiency with MS Office Suite software programs. *Aptitude in professionalism*Excellent written and oral communications skills*Ability to work evenings/weekends hours as needed. *Knowledge of medical terminology*Able to resolve problems/issues*Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants*Demonstrated organizational and prioritization skills, along with the ability to work in a dynamic environment and to perform multiple tasks simultaneously. *Knowledge of IRB and human subject protection*Ability to work independently or as a team with excellent attention to detail and adherence to project deadlines. *Ability to travel to off-site locations that may not be accessible via public transportation. *Strong time management skills Preferred Skills and Abilities:*Prior experience with IRB submissions. *Prior experience processing and shipping biological samples. *Prior phlebotomy certification or willing to learn. *Prior experience with RedCap, OnCore CTMS, Epic Research and Florence eBinders. *Prior Electronic Data Capture (eDC) data entry skills. *Prior research experience in a healthcare setting. *Prior research experience with NIH sponsored research studies, industry clinical trials, and investigator-initiated research studies. Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Go here to review. You may request a copy of the report by calling Temple University's Department of Public Safety at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC)-Kresge Science HallJob: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator. The ideal candidate will possess certification such as an MA, phlebotomy, or similar and have a strong desire to work directly with patients. Who We Are ObjectiveHealth is a clinical research company that uses proprietary technology to: * Increase patient access to research trials within our communities, * Provide physicians with enhanced care options for current patients, and * Deliver superior clinical research enrollment metrics to Pharma sponsors All with the goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that. Who You Are * A lover of patient interaction and skilled at providing patient care * A team player with a bias for action and an attitude that takes personal responsibility * Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc. * Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc. * Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence * An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others * A strong advocate for Company values, mission, and initiatives * Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies * Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Dermatology, and/or Oncology What Success Looks Like for This Role * Taking ownership of assigned studies and patients * Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction * Showing up on time, every time * Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies * Learning and using the technologies we provide to increase efficiency in your day-to-day activities * Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication What We Offer Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits. Requirements This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.

Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator. The ideal candidate will possess certification such as an MA, phlebotomy, or similar and have a strong desire to work directly with patients. Who We Are ObjectiveHealth is a clinical research company that uses proprietary technology to: Increase patient access to research trials within our communities, Provide physicians with enhanced care options for current patients, and Deliver superior clinical research enrollment metrics to Pharma sponsors All with the goal of Improving Patient Outcomes at the Point of Care . We want you to join us in doing just that. Who You Are A lover of patient interaction and skilled at providing patient care A team player with a bias for action and an attitude that takes personal responsibility Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc. Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc. Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others A strong advocate for Company values, mission, and initiatives Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Dermatology, and/or Oncology What Success Looks Like for This Role Taking ownership of assigned studies and patients Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction Showing up on time, every time Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies Learning and using the technologies we provide to increase efficiency in your day-to-day activities Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication What We Offer Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits. Requirements This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.

Clinical Research Associate - Oncology - West Region (AZ, CO, CA) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. What You Will Be Doing: * Serve as the primary point of contact between investigational sites and the sponsor * Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out * Ensure site compliance with ICH-GCP, SOPs, and regulations * Maintain up-to-date documentation in CTMS and eTMF systems * Support and track site staff training and maintain compliance records * Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting * Support subject recruitment and retention efforts at the site level * Oversee drug accountability and ensure proper storage, return, or destruction * Resolve data queries and drive timely, high-quality data entry * Document site progress and escalate risks or issues to the clinical team * Assist in tracking site budgets and ensuring timely site payments (as applicable) * Collaborate with cross-functional partners including CTAs, LTMs, and CTMs You are: * A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN * Eligible to work in United States without visa sponsorship * A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry * Experienced across multiple therapeutic areas, ideally including Oncology (Prostate Cancer, and Lung Cancer) and Hematology * Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF * A clear communicator, problem-solver, and collaborative team player * Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in the West region (Phoenix, AZ, Denver, CO, Los Angeles or San Francisco, CA) near major HUB airports to support efficient regional travel 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 maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here 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. Are you a current ICON Employee? Please click here to apply

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Clinical Research Coordinator at Wake Research, an M3 company. This position is on-site and located in Dallas, TX. The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Essential Duties and Responsibilities: * Assisting trial Investigator in screening and review of potential study participants eligibility * Maintaining case report forms, charts and documentation * Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants * Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements * Collecting and entering data as necessary * Assist management with potential new hire selection and shadowing process * Assist with study start-up, maintenance, and close-out of studies as needed for those on the team * Ability to be flexible with study assignments Qualifications * Clinical Research Coordinator with 1-2 years of experience * Phlebotomy experience preferred * Excellent verbal & written communication skills * Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking * Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines * Extensive clinical trial knowledge through education and/or experience * Successful completion of GCP Certification and Advanced CRC preferred * Detail-oriented * Familiarity with the Code of Federal Regulations as they pertain to human subject protection * Strong interpersonal skills Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: * 401(k), 401(k) matching * Dental insurance * Disability insurance * Employee assistance program * Flexible spending account * Health insurance * Life insurance * Paid time off * Vision insurance * M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1