Clinical Research Coordinator jobs at M3 Global Research

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 contract Clinical Research Coordinator at Wake Research, an M3 company. This is an on-site position. A Clinical Research Coordinator (contract/PRN) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial. Essential services to be performed: * Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses. * Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management. * Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures. * Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria. * Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials. * Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc. * In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed. * Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents. * Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review. * Assists with timely completion of case report forms, if appropriately delegated/trained. * Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability. * Assists fellow co-workers with studies as time and ability permits. Qualifications * Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs. * Successful completion of the GCP certification. * Phlebotomy and EKG experience. * +2 years of CRC experience is preferred. 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

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

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 Title: Clinical Study Manager-Remote Location: Collegeville, PA Duration: 36 months Job Description: This position is needed to assist with Inspection Readiness Prepartion. The candidate will need to assist in leading diverse CRO teams through the Inspection Readiness process. Strong pTMF experience is also desired. A large component of the position will be to search for documents in pTMF and work with 2 different CRO to ensure that all documents are present in pTMF. Strong understanding of clinical trial documents is needed as well as a thorough understanding of a sponsor Inspection. The candidate should be flexible and able to positvely influence CRO staff while meeting the needs of the business. The candidate will also be asked to assist with filing protocol amendments in pTMF, ICD updates, and helping the COSTL and Clinican with tasks on an ad hoc basis. The candidate will lead 2 CROs through Inspection Readiness Activities for a large, high visibility, global oncology protocol that is in submission. The candidate needs to be able to influence and lead the 2 CROs through the Inspection Readiness checklist (~500 items). All items on the checklist will need to be reviewed, the location of the documents will need to be identified and entered onto the checklist. The candidate will need to be able to navigate through pTMF to ensure all documents are in pTMF in the correct cabinet and folder. The candidate will need to be proficient at searching for documents such as Monitoring Visit Reports, Financial Disclosure Documents, SOPs, vendor oversight plans. The candidate will need to compile a listing of relevant SOPs used on the study both past and present and download those SOPs into folders on a sharepoint space. The candidate will need to be comfortable leading 2 CROs in document retrieval and ensuring all Inspection Readiness Documents are up to date with the correct versions. The candidate will need to work with the 2 CROs for any corrections or updates needed. Additional Skills: pTMF, Inspection Readiness activities, Study conduct activities. Qualifications BS Additional Information For More information, Contact Best Regards, Akriti Gupta ************** Morristown, NJ 07960

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

A Few Words About Us 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 RESPONSIBILITIES: • The Supporting Clinician will provide medical and scientific study and project support for multiple, global, Phase 1-4 clinical studies in a clinical program. • coordinating and leading the investigation process on all manufacturing and laboratory incidents related to all deviations including biomanufacturing process and equipment deviations and deviations for all analytical assays. • protocol and study training • Data review and interpretation • study and/or program scientific and integrity oversight • safety review and communication • regulatory document, study report and publication preparation and review • Independently write/design protocol outlines, protocols, and amendments of moderate complexity in collaboration with the Lead Clinician • Support the preparation of other clinical documents as required • DATA REVIEW AND INTERPRETATION: o Proactively coordinate with the Lead Clinician to assure understanding and agreement on deliverables o Responsible for review of patient level data across a study and coordinating with Lead Clinician for study level review as delegated o Study analysis and decision point preparation o Interprets data and is able to identify issues of moderate/difficult complexity o Conducts data review independently • STUDY MEDICAL OVERSIGHT: o Collaborates with the Lead Study Clinician(s) and COSTL to provide guidance during the execution of the study o Provide input into the monitoring plan • SAFETY: o Ensure timely communication of safety issues o Review and approval of subject narratives as delegated by the Lead Clinician • REGULATORY AND PUBLICATIONS: o Provide input, review and edit clinical study reports (CSR) o Provide full review of content and integrates information from literature and other sources as appropriate o Support and contribute to various sections of regulatory filings (Pediatric Investigational Plan, IB, IND/NDA Annual Reports, and PSURs and Regulatory authority responses) o Audit responses as delegated by the Lead Clinician • CLINICAL PROGRAM IMPLEMENTATION: o Ensure regulatory compliance and GCP adherence at the study level with regard to medical/scientific issues o Initiate and coordinate corrective action for major medical/safety/scientific study level issues o Along with Lead Study Clinician(s) and COSTL and with regard to medical/safety concerns, ensures study level issues are resolved o Collaborate with Lead Clinician and COSTL to arrive at major site level decisions based on input from the team o Coordinates with Lead Study Clinician(s) and COSTL to maintain study timelines o Along with the Lead Study Clinician(s) and COSTL and other study team members, participates in training of Study Management Staff and monitoring staff o In collaboration with the Lead Study Clinician(s) and COSTL and study team, ensures the clinical trial material requirements of the study are met o Ensure standard processes, tools, and procedures used consistently and globally o Participates in developing training strategy for study with the study team members Provide input into the preparation of study level training materials in collaboration with Lead Study Clinician(s) and COSTL and team members o Ensures appropriate filing of documentation in the trial master file Qualifications QUALIFICATIONS AND SKILLS NEEDED: • M.D., PhD, Pharm. D. Degree in science or health-related field preferred, will consider highly motivated and experienced MA or MS • 10+ years of pharmaceutical/CRO experience preferred TECHNICAL SKILLS: • Has extensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field • Has demonstrated ability and level of experience with integrating and summarizing medical/scientific concepts in protocols and other clinical documents • Has independently authored clinical study documents • Has experience with participating in and informally leading an operational team • Applies knowledge of internal/external business challenges to facilitate process improvements • Has ability to proactively resolve issues and work independently with minimal supervision • Has working knowledge of statistics, data analysis, and data interpretation • Has exceptional written and oral communication and cross-functional collaborative skills • Is proficient in MS Word, Excel, and PowerPoint

Mindlance is a national recruiting company which partners with many of the leading employers in the Life Sciences, IT, and Financial Services sectors, feel free to check us out at ************************* Job Description • This role is to provide comprehensive project coordination support for reducing the risk of phishing by supporting Info Protect Culture Change Behavioral Research Project • Clinical experience is helpful but not mandatory • Provide operational support and project administration for the Info Protect Culture Change Behavioral Research Project. The role entails coordinating clinical project development and implementation, project monitoring and control, risk management, and project governance. Efforts must adhere to principles of transparency across the programs and enable comparability with other efforts. Incumbent will serve as an operational 'single point of contact'; Collaborate with internal and external partners and vendors; Develop and implement project activities as assigned by the project manager; Track study budget spend and report monthly; Review and reconcile invoices for payment approval; and create and maintain project documentation including project plans, meeting minutes and agenda, project risk and decision logs, and other documents needed for project execution. Qualifications • Experience running clinical trials or University studies not required but recommended. • Project Admin/Coordinator - Level of knowledge/expertise: Extensive capability and expert understanding Job Profile: project admin/coordinator Provide administrative project planning support to Programme/Project Manager as required and provide plans converted into various formats Convert the output of the PM meeting into a monthly report and maintain the ISAC and FPAC project tracking tools Provide support to the PMO as requested. • The Information Protection programme at multi-year global programme to protect information. Within the programme, there is an Information Protection Culture work stream with the goal to fundamentally drive worldwide employee culture change for protecting information through education and awareness.

Clinical Research Associate - Remote - US 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 Senior Clinical Research Associate or Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate 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 1 year independent monitoring to be considered for a Clinical Research Associate II and a minimum of 3 years independent monitoring to be considered for a Senior 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 #LI-Remote #LI-AR2 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

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 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 12 months onsite monitoring experience as a Clinical Research Associate; level (CRA I, CRA II, or Senior CRA) determined by total years of experience. 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

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.

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. Job Summary: Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Essential Responsibilities and Duties: Under supervision, coordinates aspects of patient involvement for complex and/or multiple studies from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Monitors, and reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assists Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes. Assists the CTM in planning, creating processes, trainings and development of staff. 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 have proper experience and demonstrate mastery of Clinical Research Coordinator I position. High school graduate or equivalent; Bachelors Degree, preferred CCRC certification preferred 2-3 years of experience in the medical field, preferred Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. 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. Overnight travel may be required for training and/or investigative meetings. 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.

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. Job Summary: Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Essential Responsibilities and Duties: Under supervision, coordinates aspects of patient involvement for complex and/or multiple studies from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Monitors, and reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assists Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes. Assists the CTM in planning, creating processes, trainings and development of staff. 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 have proper experience and demonstrate mastery of Clinical Research Coordinator I position. High school graduate or equivalent; Bachelors Degree, preferred CCRC certification preferred 2-3 years of experience in the medical field, preferred Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. 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. Overnight travel may be required for training and/or investigative meetings. 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.

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. Job Summary: Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Essential Responsibilities and Duties: Assists with coordinating all aspects of patient involvement from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Documents adverse events, protocol deviations, and other unanticipated problems appropriately. Reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). 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: High school graduate or equivalent; Bachelors Degree, preferred. 0-3 years of experience in the medical field. Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. 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.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. Job Description: Job Title: Clinical-Scientific - Bench Scientist I Location: Chesterfield - MO Duration: 12 Months+ The Associate Scientist position is available within the Conjugation and Polytides Process Development (CPPD) group in Bioprocess R&D. Working within a team setting, the successful applicant will support the development of innovative, robust, efficient, and scalable chemical and biochemical processes and technologies required for the advancement of a diverse and extensive portfolio of bio-conjugate- and polytide-derived bio therapeutics. The position will focus on providing analytical support for process characterization studies, but may also support fellow scientist in design and execution of experiments and the necessary purification activities to produce drug substances with appropriate quality attributes. The candidate will work across process development functions and projects covering a broad portfolio including vaccines, antibody-drug conjugates, therapeutic proteins, and oligonucleotides. Under the guidance of senior scientists, the candidate will perform basic analysis of process intermediates and drug substances. The candidate will also work with fellow scientists in designing and executing experiments at the laboratory scale, and based on the analyses of these studies, will be expected to develop and test new hypotheses to improve fundamental understanding of the chemical and biochemical processes, including bio-conjugation or large and small molecule combinations. This position will support drug substance and drug substance intermediate purification activities as needed. This position requires a highly motivated individual with the ability to work closely with other members of the laboratory and the department in a matrix environment. This position will also collaborate with the pilot plan and manufacturing staff on experimental studies, clinical manufacturing, and process validation, including work with external contract manufacturing organizations. Demonstrated ability to drive for results and drive innovative research programs independently. Good understanding of chemistry/biochemistry and macromolecule analytics. Familiarity with recent scientific literature is desirable. Applicants should be self-motivated, organized, and capable of working independently, and in a collaborative environment. The successful candidate will possess strong oral and written communication skills. Strong analytical and computer skills are required. Qualifications Qualification and work experience: Required: B.S. degree in Chemistry, Biology, or equivalent or related field with 0-5 years of industry experience. Proven record of delivering results in a fast paced environment and effective communication to project teams. Desirable: 2-3 years of experience with analytical techniques for biomolecules and/or process development of biotherapeutics. Additional Information All your information will be kep t confidential according to EEO guidelines. With Regards, Abhishek Singh 650-399-0881 Clinical Recruiter Integrated Resources, Inc.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. Job Description: Job Title: Clinical-Scientific - Bench Scientist I Location: Chesterfield - MO Duration: 12 Months+ The Associate Scientist position is available within the Conjugation and Polytides Process Development (CPPD) group in Bioprocess R&D. Working within a team setting, the successful applicant will support the development of innovative, robust, efficient, and scalable chemical and biochemical processes and technologies required for the advancement of a diverse and extensive portfolio of bio-conjugate- and polytide-derived bio therapeutics. The position will focus on providing analytical support for process characterization studies, but may also support fellow scientist in design and execution of experiments and the necessary purification activities to produce drug substances with appropriate quality attributes. The candidate will work across process development functions and projects covering a broad portfolio including vaccines, antibody-drug conjugates, therapeutic proteins, and oligonucleotides. Under the guidance of senior scientists, the candidate will perform basic analysis of process intermediates and drug substances. The candidate will also work with fellow scientists in designing and executing experiments at the laboratory scale, and based on the analyses of these studies, will be expected to develop and test new hypotheses to improve fundamental understanding of the chemical and biochemical processes, including bio-conjugation or large and small molecule combinations. This position will support drug substance and drug substance intermediate purification activities as needed. This position requires a highly motivated individual with the ability to work closely with other members of the laboratory and the department in a matrix environment. This position will also collaborate with the pilot plan and manufacturing staff on experimental studies, clinical manufacturing, and process validation, including work with external contract manufacturing organizations. Demonstrated ability to drive for results and drive innovative research programs independently. Good understanding of chemistry/biochemistry and macromolecule analytics. Familiarity with recent scientific literature is desirable. Applicants should be self-motivated, organized, and capable of working independently, and in a collaborative environment. The successful candidate will possess strong oral and written communication skills. Strong analytical and computer skills are required. Qualifications Qualification and work experience: Required: B.S. degree in Chemistry, Biology, or equivalent or related field with 0-5 years of industry experience. Proven record of delivering results in a fast paced environment and effective communication to project teams. Desirable: 2-3 years of experience with analytical techniques for biomolecules and/or process development of biotherapeutics. Additional Information All your information will be kept confidential according to EEO guidelines. With Regards, Abhishek Singh 650-399-0881 Clinical Recruiter Integrated Resources, Inc.

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

Study Start Up Manager-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 Manager, Study Start-Up to join our diverse and dynamic team. As a Manager of Study Start-Up at ICON, you will lead and oversee the start-up activities for clinical trials, ensuring that all processes are completed efficiently and in compliance with regulatory requirements. Your role will involve managing a team of professionals, working closely with cross-functional departments, and liaising with sponsors to ensure successful and timely study initiation. What You Will Be Doing: * Managing and overseeing the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation. * Leading a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery. * Collaborating with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation. * Monitoring study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope. * Identifying potential risks and challenges in the start-up process and implementing strategies to mitigate delays or issues. * Driving continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency. Your Profile: * Bachelor's degree in life sciences, clinical research, or a related field. Advanced degree or project management certification is a plus. * Extensive experience in clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations. * Proven leadership skills, with experience managing and mentoring teams in a fast-paced, deadline-driven environment. * Excellent organizational and project management skills, with the ability to handle multiple studies and priorities simultaneously. * Strong communication and stakeholder management skills, with the ability to collaborate effectively with sponsors and internal teams. * Experience with process optimization and implementing best practices in study start-up activities. 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

CRC Level 1 - Winston Salem, NC (Onsite) 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 have an incredible opportunity for a Clinical Research Coordinator 1 to join ICON's Accellacare team. The CRC ensures the safety of our volunteers, promotes the mission of Accellacare, and strives to meet and exceed study priorities. This individual is responsible for recruiting and promoting our service to suitable participants and sponsor representatives. Additionally, the CRC will perform tasks required to coordinate and complete a study according to the protocol. This role is with Accellacare, part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research. Location: Onsite (1901 S. Hawthorne Road, Suite 306, Winston-Salem, NC) What you will be doing: * Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator. * Attending investigator meetings, site initiation visits, and coordinator meetings to obtain training on drug preparation and administration and general knowledge about a protocol with a focus on clinical procedures. * Obtaining knowledge about the study drugs with an emphasis on injection or intravenous infusion medications. * Monitoring for possible complications with the administration of study drugs with an emphasis on injections or intravenous infusions. * Maintaining accurate dispensing logs, separate from those of the coordinator, to include such information as lot number, drug vs. placebo, and information about the third party mixer or un-blinded mixer/preparer of medication. * Documenting laboratory data and adverse reactions, and immediately notifying investigators, sponsors and the Institutional Review Board, if indicated, of any unexpected or serious events. * Assisting other staff members as determined by the needs and priorities of the research organization and as time and abilities permit. * Actively recruiting and effectively selling our service to suitable patient participants for clinical trials with set time allotted each week for recruitment efforts. * Proactively promoting the site with monitors and in-house contacts for future trials. * Responding to queries in a timely manner, prompt data entry and working with the monitor during on-site visits are examples of pro-active behaviors. * Preparing study documentation in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit. * Ordering clinical supplies, as well as ordering, storing and monitoring of protocol specific rescue drugs and maintaining scheduled assessment of the code/crash cart and AED including maintaining proper documentation for both. * Monitoring and maintaining refrigerators, freezer units and investigational product storage temperatures for safety and stability. * Obtaining and maintaining knowledge in regards to temperature monitoring devices and procedures for lab specimens and investigational products and providing detailed information to all staff and sponsors in regards to how temperatures are monitored and maintained. * Maintaining certification for packaging and shipping specimens on dry ice, as well as maintaining and updating knowledge of lab procedures to assist with work flow. * Acting as the OSHA Representative for the site which would include but not be limited to; maintaining employee immunization records, obtaining vaccines when necessary for site or PMG and administering vaccines to staff. * Performing equipment calibration when needed, if not performed by the lab coordinator or outside service and maintaining equipment calibration records. * Supporting training and additional development of clinical skills for site staff as needed Your Profile: * 1+ years of work experience in a clinical research or pharmaceutical environment, with prior CRC experience * Experience with Neurology or Psychiatric clinical trials * Strong attention to detail * Motivated about a career in clinical research * Excellent time management and planning skills with an organized approach to work * Bachelor's degree in life sciences or other related field #LI-Office #LI-SB4 #LI-Accellacare 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

Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator II. The ideal candidate will possess 3+ years of clinical research coordination experience, 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.

RN-Clin Research Nurse - (25002825) Description Temple University's Lewis Katz School of Medicine's Pulm/Critical Care/SleepMed Department is searching for a RN-Clinical Research Nurse 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: N03Hire rate based on the date of licensure 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 position will be on-site*This position requires the following background checks: Cash Handling*This is a grant funded position Position Summary: The RN-Clinical Research Nurse in Lewis Katz School of Medicine' s Thoracic Medicine and Surgery (TMS) Department will be responsible for the day-to-day activities surrounding clinical research studies, and will ensure compliance with federal, state and university regulations. The incumbent will work with investigators on multiple active protocols and will interact closely with the sponsors from qualification visits to close-out visits. The Temple Lung Center has one of the most active and wide-ranging pulmonary research programs in the world. Areas of focus include COPD, emphysema, respiratory failure, lung transplantation, pulmonary arterial hypertension, alpha 1-antitrypsin deficiency, asthma, lung cancer, sarcoidosis, pulmonary fibrosis and sleep apnea. Our program also maintains a strong clinical research program with studies and clinical trials that test new medications, devices or procedures in patients in order to find more effective treatments. The Temple Lung Center typically has several dozen open clinical trials at any one time and consistently ranks among the highest enrolling sites for pulmonary clinical trials in the nation. ************ templehealth. org/services/lung/research-clinical-trials/research-focus-areas Click here to learn more about the benefits of working at Temple University. Required Education and Experience: * Professional licensure as a Registered Nurse in the Commonwealth of PA, with previous research experience in a research and/or clinical trials setting. Responsibilities: *Performing nursing assessments and procedures*Participating in the review and preparation of protocols for clinical trials*Recruiting and enrolling study subjects, and coordinating visits*Obtaining informed consent*Scheduling patient admissions related to study procedures*Serving as a patient advocate, and educating and counseling patients and families*Ensuring that clinical trials are followed by clinical research staff*Monitoring patient care, and assessing patient status and treatment side effects*Maintaining regulatory documentation and managing IRB submissions and follow-ups*Overseeing data collection and management in accordance with trial protocol*Responsible for assisting with budget preparation and tracking expenditure. *Must be able to travel to multiple sites. *Performs other related duties as assigned. Required Skills & Abilities:*Professional licensure as a Registered Nurse in the Commonwealth of PA*Ability to apply scientific principles to problem solving, planning, as well as providing and evaluating nursing care. *Demonstrated knowledge and understanding of complex federal regulations, ethical issues, institutional policies, and other federal agency requirements governing human subjects research. *Demonstrated knowledge of quality assurance or auditing functions. *Demonstrated computer skills, and proficiency with MS Word, MS PowerPoint, MS Access or similar software programs. *Excellent verbal and written communication skills, including training skills. *Demonstrated organizational and time management skills, along with the ability to work under tight deadlines. *Demonstrated ability to be detail-oriented. *Demonstrated ability to work independently and as part of a team. *Must maintain a working knowledge of current regulations, guidelines, and trends influencing the conduct of human subjects research. *Ability to travel to off-site locations that may not be accessible via public transportation. *Ability to work overtime and nights/weekends/early mornings, as needed. Preferred:*Experience with biomedical human research is preferred. 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. Click here. 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