Clinical Research Assistant jobs at M3 Global Research

Sr. CRA , Midwest, Remote ( Michigan, Ohio, Illinois, Wisconsin, Indiana ) 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 (CRA) in the Midwest Region to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle. Ideal locations would be: * Kansas City, MO * St. Louis, MO * Des Moines, IA * Wichita, KS, * Chicago, IL * Omaha, NE What You Will Be Doing: * Perform site management activities to support Oncology site success and maintain a continuous state of inspection readiness * Act as the primary contact and facilitate efficient communications between the clinical trial team and the sites * Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in trials * May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs * Promptly document monitoring activities and submit/approve visit reports * Manage site essential document collection and TMF reconciliation with site files * Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals * Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution * Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans * Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations * Support sites during regulatory inspections * Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities * Lead site engagement initiatives and foster relationships with key Oncology sites and networks Your Profile: * Bachelor's degree (scientific field preferred) * 5+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits * 1+ years early development trial experience preferred * Solid tumor clinical trial experience is preferred * Experience utilizing Veeva CTMS for report writing is required * Demonstrated experience developing/maintaining site relationships and securing compliance * Expertise in GCPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology * Experience collaborating with sites from initial engagement through close-out phases * Experience activating sites * Experience training site staff * Experience supporting sites and/or sponsors in regulatory inspections * Experience working within an FSP (or in-house) monitoring model is preferred * Willing to travel up to 50% domestically * Reside in Midwest Region USA 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 - 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

Assist in the collection and documentation of study activities and procedures. Maintain study areas and equipment in a tidy and operational state. Assist study team in conduct of research studies Essential Functions /principal accountabilities Performs competencies and job requirements as trained and delegated and as applicable to study protocols. Collects data according to protocol/clinic SOP' Performs all job responsibilities in accordance with standards of GCP (Good Clinical Practice), clinic SOPs, OSHA guidelines, Federal and local regulations Completes all required training programs per company requirements Honors password protections and confidentiality. Reports to Director/Manager/Coordinator of Clinical Services on all administrative, logistical and staff related site issues. Responsible to the Principal Investigator (PI) on all aspects of study conduct. Timely evaluation/sign-off of study documentation. Ensures Correct Procedures are performed in a timely manner on the correct participant according to Protocol requirements. Ensures study participants confidentiality and HIPAA compliance. As per Job Description and as trained and delegated by the Medical Director or Principal Investigator and as allowed by sponsor: Performs study procedures: Specimen Collection Phlebotomy Perform CLIA waived tests and specimen processing Vital signs, EKG's Height, weight, and BMI calculations Product Dispensing and Accountability Other procedures as trained and delegated Manages receipt, distribution, supervision, and documentation of study participant's meals Monitor bathrooms Preparation of Study Areas: Ensure study and participant areas are cleaned and maintained in a tidy and organized manner Ensure equipment is set up and ready for use Provides study scrubs and linens for study participants Provides other general assistance to the clinic team such as labeling of study supplies, study room arrangement and bed assignment Make calls to study participants to confirm study activities/restrictions/reminders Study Participant Recruitment Represent Facility in Community Events and Health Screening Programs Performance of and Management of Pre-Screening and Screening Procedures Preparation of study source binders Filing of source documents in a timely manner Complete source documentation accurately, legibly and in real time. Review source documents on an ongoing basis to ensure accuracy and completeness. Correct source documentation errors in a timely manner Report deviations or study related issues to supervisor Enforce clinic rules and regulations Search study participants personal belongings brought to the clinical research center for contraband Verification of Investigational Product and Concomitant Medication Administration Ensure study participants are available for procedures in a timely manner Educate study participants regarding study procedures being performed Assisting in the training of new staff members Assist other departments as needed

Senior Clinical Research Associate (home based) (Level dependent on experience) To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. What You'll Do Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor. Creates and implements subject enrollment strategies for assigned investigative sites. Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan. Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material. Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product. Participates in development of CRFs and other study related documents What You Bring Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

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.

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: Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies. Compensation: $20-21/h Essential Responsibilities and Duties: Creating and maintaining patient charts for all assigned studies. Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate. Filing of lab results, EKG results, and other communication in designated patient charts. Maintaining inventory of study specific supplies including lab kits, assessments and participant facing materials. Timely completion of data entry and query resolution for all CRFs, based on sponsor specific timelines and deadlines established in contract or other communication. Assisting Coordinators in assessments, including but not limited to, blood pressure, urine collection. Communicating with study participants, caregivers, third party vendors and laboratories as needed. Assisting Coordinators with scheduling, copying, faxing, and other clerical tasks. Aiding Coordinators in the facilitation of study monitoring visits. Completion of daily responsibilities delegated by CRC as they pertain to the study and/or participants. 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: Interest in and knowledge of specific study indications. Excellent computer skills and advanced knowledge of electronic equipment (i.e., e-mail, computer, fax machine, copier, etc.). Skilled in organization and record maintenance. Phlebotomy experience preferred. Experience working with patients. Skilled in developing and maintaining effective working relationships with supervisors and co- workers. Strong personal initiative and attention to detail. Ability to react calmly and effectively in emergency situations. Ability to interpret, adapt and apply guidelines and procedures. Ability to clearly communicate both orally and verbally. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. 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. Hourly Rate: 19.00 -$21.00/hr (Depending on education, experience, and skillset) Schedule: 08:00 am - 4:30 PM - Monday - Friday Job Summary: Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies. Essential Responsibilities and Duties: Creating and maintaining patient charts for all assigned studies. Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate. Filing of lab results, EKG results, and other communication in designated patient charts. Maintaining inventory of study specific supplies including lab kits, assessments and participant facing materials. Timely completion of data entry and query resolution for all CRFs, based on sponsor specific timelines and deadlines established in contract or other communication. Assisting Coordinators in assessments, including but not limited to, blood pressure, urine collection. Communicating with study participants, caregivers, third party vendors and laboratories as needed. Assisting Coordinators with scheduling, copying, faxing, and other clerical tasks. Aiding Coordinators in the facilitation of study monitoring visits. Completion of daily responsibilities delegated by CRC as they pertain to the study and/or participants. 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: Interest in and knowledge of specific study indications. Excellent computer skills and advanced knowledge of electronic equipment (i.e., e-mail, computer, fax machine, copier, etc.). Skilled in organization and record maintenance. Phlebotomy experience preferred. Experience working with patients. Skilled in developing and maintaining effective working relationships with supervisors and co- workers. Strong personal initiative and attention to detail. Ability to react calmly and effectively in emergency situations. Ability to interpret, adapt and apply guidelines and procedures. Ability to clearly communicate both orally and verbally in both English and Spanish. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. 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.

CRA II or Senior CRA-US-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. ICON plc is seeking an experienced Senior Clinical Research Associate (Senior CRA) or Clinical Research Associate (CRA) to join our dynamic, collaborative team. In this role, you will be a key contributor to the successful execution of clinical trials, ensuring studies are conducted in full alignment with protocols, regulatory requirements, and industry standards. Your work will directly support data integrity, participant safety, and overall study excellence. 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. * At least 1 year of independent monitoring experience for CRA II consideration and 3 years for Senior CRA. * Strong knowledge of clinical trial processes, regulatory requirements, and ICH-GCP guidelines, with a genuine interest in high-quality research. * Excellent communication and organizational skills with strong attention to detail. * Ability to work both independently and collaboratively while contributing to a positive, fast-paced team environment. * Ability to travel approximately 60 percent of the time, both domestically and internationally by air and car, with a valid driver's license required. #LI-JG1 #LI-Remote 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

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.

Senior Research Administrator - (25002145) Description Temple University's Lewis Katz School of Medicine is searching for a Sr. Research Administrator! Salary Grade: T29 Click here to view some university guidelines regarding internal transfers, lateral moves and promotions. Salary Range: $110,000 - $130,000 A 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 Become a part of the Temple family and you will have access to the following: A hybrid work schedule Full medical, dental, vision coverage Paid time off 9 Federally Observed Paid Holidays 3 Personal Days Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE A generous retirement plan and so much more! Position Summary: Reporting to the Sr. Director, Basic Science Research Administration, The Senior Administrator has administrative responsibility for the assigned centers including fiscal responsibility for all research-related accounts, gifts, endowments, and operating funds. Provides high-level review of all Center funding on a monthly basis, provide financial oversight, planning and expense projections in support of the assigned Center(s). The Senior Administrator directs and manages all business processes for faculty and staff including managing salaries; procurement; budget administration; pre-award grant submission and post award grant administration including cost transfers. As Senior Administrator, you will be expected to strategize with the faculty and fellows you support to provide management of their financial research portfolio, suggest funding opportunities, advise on potential funding gaps/issues, monitor and enforce compliance with sponsor guidelines, OMB Uniform Guidance as well as adherence to Temple University policies. Job Details: * This position requires a background check for cash handling responsibilities. Required Education and Experience: * Bachelor's Degree and at least 7 years of directly related experience. An equivalent combination of education and experience may be considered. Preferred Education and Experience: * Master's degree.* Research Administration experience within a higher education or medical setting Required Skills and Abilities: *Demonstrated computer skills, and proficiency with database and spreadsheet software programs.*Demonstrated financial analysis skills, and ability to manage large data sets.*Demonstrated ability to create and manage budgets.*Demonstrated leadership, management, and decision-making skills.*Demonstrated ability to innovate and collaborate regarding research initiatives.*Demonstrated knowledge of standard operating procedures and clinical research regulations, included but not limited to IRB and FDA regulations.*Demonstrated organizational and prioritization skills, along with the ability to be detail-oriented.*Ability to execute decisions with a sense of urgency, and work under pressure to meet deadlines.*Strong written and verbal communication skills, to include report writing skills.*Strong interpersonal skills, and ability to interact effectively with a diverse constituent population. Essential Duties: * Fiscal responsibility for all research related accounts, gifts, endowments and operating funds for the unit assigned. This includes projections and financial planning fo the unit.* Manage all pre and post award activity for the unit assigned including sponsored program submissions, progress reports and closeouts. Monitors expenditures for adherence to university and agency guidelines. Ensures accurate invoicing of accounts and timely submission of final expenditure reports by Research Accounting Services. * Human Resource/Personnel management including hiring, onboarding, payroll updates, visa processing, performance management and staff development. Supervises Administrative Coordinators assigned to unit.* Conducts monthly meetings with unit investigators to review financial portfolio, provide guidance and disseminate funding information.* Ensure that effort reports are consistent with all time and effort records and with commitments to external sponsors. * Reviews and authorizes all purchases and reimbursements for both sponsored and non-sponsored accounts.* Assists unit leader(s) in the development of new or expanded/modified programs including cost and ROI analyses as appropriate.* Manages day to day operation of the supported units* Prepares annual IDC budget in Hyperion.* Monitors unit spending and reports on variances to budget.* Assists in preparation of annual report for the unit to the Dean.* Serves as liaison for unit with all School/University offices.* Participates in assigned internal and external committees.* Performs other duties as assigned. 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 Campus Safety Services at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC)-Medical Education and Research BuildingJob: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

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.

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

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.

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

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: This individual contributor is responsible for the management of clinical supplies during the execution phase of clinical trials consistent with GMP guidelines with a specific focus on Temperature Management & Control of Clinical Supplies. Description of the Role •Responsible for management of 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 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 •Conduct issue resolution activities for the temperature excursion supply aspects of the clinical trials •Develop strong internal collaboration with GCO, DPD, and Quality stakeholders to ensure 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 Pharma R&D for all phases of clinical trials •Review and approval of all Investigational Site Temperature Management Equipment Questionnaire Approvals (TMEQ) for Cold Chain IMP •Act as subject matter experts for temperature management requirements including storage and monitoring capabilities •Customizing protocol specific temperature out-of-range forms based on product attributes •Coordinating quote request and 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 business process improvement initiatives. Focus and Scope Responsible for the Temperature Management & Control of all clinical supplies from feasibility throughout trial execution Critical Experiences Required • A university/bachelor's degree (or equivalent experience) is required. Generally, requires 2+ years related experience. •Experience with quality system tools preferred (e.g. Trackwise) •Experience with Interactive Response Technologies for Clinical Trials (e.g. inventory management functionality) •Experience with the following functions preferred: clinical operations, logistics, quality assurance, clinical supply chain planning, drug product development •Demonstrated knowledge in the following areas: •Clinical Supply Distribution •Clinical Study Execution/GCP •Intermediate to advanced software skills (e.g., Microsoft Excel, SharePoint, PowerPoint) •Experience in a highly matrixes environment (preferred) Critical Competencies: •Very strong data analysis and problem solving experience •Highly organized with strong attention to detail •Extreme sense of urgency for the tasks at hand, including ability to drive resolution with minimal management oversight •Excellent written and verbal communication skills •Task oriented (repetitive process) •Strong quality management skills •Strong strategic thinking skills •Excellent problem solving and decision making skills •Strong cross-functional coordination skills Additional Information Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus. Thank you. Kind Regards, Harris Kaushik Clinical Recruiter Integrated Resources , Inc. IT Life Sciences Allied Healthcare CRO DIRECT # - (650)-399-0891 Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5 0 0 0 's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)