Clinical Engineering Project Manager
Clinical research associate job in Greensboro, NC
Title: Clinical Engineering Project Manager
Duration: 3-4 months (High Likelihood of extension)
Hybrid: (Will coverany bi-weekly/monthly travel costs- few days a month onsite preferred)
Role Overview
Precise. Reliable. Powerful. Join a team as innovative as the technology we manage.
Due to expansion, our healthcare client is expanding the HTM Projects Management team. This opportunity will work on capital and large projects. Their HTM division is looking for a Project Manager to oversee capital planning of medical devices and acquisitions along with service contract review. A Clinical Engineer degree is not required, but preferred. Project Management in a healthcare setting preferred.
Are you a Clinical Engineer or lead biomedical/imaging equipment technology professional who has strong project management experience/training? Here's your opportunity to use analytic skills to manage and make recommendations for equipment replacement planning and forecasting.
What You'll Do
Coordinate the implementation of a defined, short-term project or sub-set of projects (less than one year) within set organizational procedures and standards.
Responsible for meeting sub-set objectives within quality, time, and budget targets, and for managing associated risks.
Typical knowledge and experience of the technical area being managed and an awareness of the business issues.
What We Offer
Compensation is fair and equitable, partially determined by a candidate's education level or years of relevant experience. Salary offers are based on a candidate's specific criteria, like experience, skills, education, and training. Sodexo offers a comprehensive benefits package that may include:
Medical, Dental, Vision Care and Wellness Programs
401(k) Plan with Matching Contributions
Paid Time Off and Company Holidays
Career Growth Opportunities and Tuition Reimbursement
More extensive information is provided to new employees upon hire.
What You Bring
Background in clinical engineering with medical devices and project management, specific to equipment replacement planning & forecasting and contracts analysis;
Clinical Engineering degree or equivalent experience, 3-5 years in a healthcare setting. This position will manage the capital process of medical equipment from start to finish.
Experience providing analysis, consultation, and research to establish project timelines and deliverables;
Participated in cross functional project teams to determine the most appropriate equipment service, purchases, and agreements;
Experience in managing projects, being well organized, self-motivated, and have excellent communication skills.
Study USA Coordinator
Clinical research associate job in Elon, NC
Title: Study USA Coordinator Position Type: Staff Full-Time Days Per Week: M-F Hours Per Week: 40 VP Area: Office of the Provost and Academic Affairs Department: Global Engagement Reporting to the Director of Study USA within the Isabella Cannon Global Education Center (GEC), this 12-month, full-time position manages a portfolio of Elon's University's signature Study USA programs and serves as a general advisor for students considering study away options.
Benefits of Working at Elon
As an Elon University employee, you'll join an internationally acclaimed university with a commitment to fostering a thriving community. Ranked among the most innovative, creative and best-run universities in the nation, Elon's personal approach to education extends to employees, whose growth, professional development and success is a hallmark of our training and advancement opportunities.
Elon University's home is the charming town of Elon, North Carolina, a small, friendly community located a short distance from the beach and the mountains, and among the vibrant cities of Greensboro, Raleigh and Durham. In addition to the beautiful canopy of historic oak trees iconic to our campus, you'll find boundless opportunities for family-friendly recreation, cultural events and outdoor activities. Hiking, water sports, fine dining and entertainment are just a few of the many happenings in the Elon area, making the region one of the nation's premier travel destinations.
Employees at Elon enjoy a generous and comprehensive benefits package that includes:
28 annual days off, including holidays and vacation.
Immediate tuition remission for undergraduate courses
Tuition remission for approved graduate-level courses after 12 months of employment.
Retirement plan with an 8 percent contribution from the university.
Immediate eligibility for health, dental and vision insurance, along with free acute care and lab services at our onsite Health & Wellness Clinic.
Free use of campus fitness facilities.
Free admission to musical and theater performances, guest speakers, religious and ethnic observances, recitals, art exhibitions, entertainment and our Division I Phoenix athletics.
Eligibility for tuition remission at Elon for spouses, qualifying domestic partners and dependents begins at two years of service. After two years of employment, eligibility begins for participation in the Tuition Exchange, a national scholarship exchange program that enables dependents to enroll in nationally recognized partner colleges and universities.
Elon values and celebrates the diverse backgrounds, cultures, experiences and perspectives of our community members. As an equal opportunity employer, Elon's principles of diversity extend to race and gender identity, age, disability status, veteran status, sexual orientation, religion, and other aspects of one's identity. At Elon, our employees respect human differences, passion for lifelong learning, emphasis on personal integrity and an ethic of service.
Minimum Required Education and Experience
Bachelor's degree with minimum 1 year of experience with the following relevant work experience: Preference for prior professional experience in a unit related to experiential learning (service, internship, research, leadership) at a four-year college/university, or the equivalent. Commitment to diversity, equity, and inclusion.
Preferred Education and Experience
Bachelor's degree in in relevant field of study
Job Duties
* Program Management
* Manage logistical aspects of Study USA programs including Study USA in NYC, DC, Charlotte, and other assigned programs, in coordination with the Director of Study USA and other key stakeholders.
* Support data collection and analysis to monitor program growth and identify areas for improvement.
* Organize and maintain excel spreadsheets of internships, alumni, and student support resources to ensure accurate and accessible information.
* Create and maintain records of internships, alumni, and student resources.
* Provide support to faculty and staff within assigned programs.
* Support on-campus student recruitment in Study USA through programming and campus partners.
* Student Support and Advising
* Advise students on program selection for Study USA program centers and select short-term programs including tabling at Quick Questions.
* In coordination with the Assistant Director of Career Services for Study USA and International Students and Director of Study USA, mentor and prepare students for internships.
* Conduct series of predeparture workshops and a reentry experience for participants.
* Provide crisis management support and counseling for students participating in assigned programs.
* Liaise with other offices on main campus to support students during pre-departure, on-program and during re-entry as necessary.
* Communications and Relationships
* In coordination with the Communications Manager, assist with updates to Study USA webpages and brochures.
* In coordination with the Director of Study USA, assist in development and implementation of outreach and communications plan.
* Maintain connections and relationships with Elon alumni who live within New York City and DC through planned events, social media, and regular interaction, in coordination with the SPDC, Alumni Office, and Student Affairs.
* Additional Experiential & Non-GEC Programs
* Serve as the GEC point person for experiential learning including overseas research, internships, and service-learning.
* Serve as liaison and support person for study away Athletics programs, Periclean Scholars, Honors, and the Truitt Center.
* Serve as the GEC point person for graduate-level study away programs, providing resources and assistance, as needed.
* Inclusive Community Building Community is foundational to Elon and a shared responsibility within our residential campus. All who work at Elon should demonstrate an understanding of and engagement with Elon's foundational commitment to relationships, mentoring and collaboration in a close-knit residential community. We embrace the shared responsibility to foster inclusive excellence within a strong residential community. Accordingly, employees are expected to join together and build connections in activities that foster an active and engaged campus environment and engage in professional development to support the shared responsibility of enriching diversity, equity, and inclusion through meaningful relationships and mentoring at Elon. Employees are encouraged to, for example, attend or participate in campus activities such as College Coffee, Numen Lumen, campus cultural events, athletic events, continuing education, professional development opportunities and trainings, employee resource groups and other university-sponsored activities to demonstrate an active commitment to the Elon community.
Special Instructions to Applicants: Applicants are asked to submit both a resume and cover letter for full consideration.
Clinical Research Associate (CRA) - NC, VA, MD
Clinical research associate job in Raleigh, NC
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
Clinical Research Associate (CRA)
Clinical research associate job in Raleigh, NC
Job Description
Peachtree BioResearch Solutions, a Julius Clinical Company, is a global specialized full-service CRO providing highly specialized study operations teams for pharmaceutical, biotech, and medical device companies. Formed over 15 years ago by a pharma leadership team experienced in
buying
CRO services with the purpose of creating trusting partnerships with sponsor clients - no matter their budget. We do this by investing in people who thrive in an environment where their experience and contributions can be felt throughout the organization. It's an exciting time as we expand our global reach, while still offering a personalized approach to sponsors and delivering incredible value.
Peachtree Bioresearch Solutions is a fast growing, full-service Clinical Research Organization with expertise in CNS and other therapeutic areas. We create strong, consultative relationships with sponsor clients and we're looking to add CRAs who are dedicated, want to make an impact, and enjoy having visibility across the entire project beyond their monitoring role.
As a small/mid CRO, we focus on building great teams where all ops functions can provide a high level of service. You can see the impact you make, and get recognized for it. It's also fun working with others who are very good at what they do.
Responsibilities:
Work closely with the Site Management team and sponsor stakeholders so you can plan and manage your work most effectively
Perform site selection, initiation, monitoring and close-out visits, plus maintain the appropriate documentation
Establish relationships with sites while administering protocol and related study training
Work with Peachtree's Data Management team and sites to ensure all queries are resolved
Complete all reports and follow up items in a timely manner
Work with project leadership to customize solutions that bring value to the sponsor
Qualifications:
Bachelor's degree
1-5 years of experience working on clinical trials (CRO or Sponsor) with at least a year of site monitoring
Experience on CNS or neuro studies highly desirable
Willing to travel 65%. Sometimes it's hectic. Sometimes it's not. We do a good job trying to manage it.
Highly proficient with business software (MS365)
Experience working in a CTMS and EDC system
Excellent organizational and critical thinking skills
Excellent written and verbal communication and presentation skills
Be resourceful and curious - you figure out problems and think about the business beyond the task at hand.
A team player who elevates others
Leadership traits and attitude
In addition to working with great people on high performing teams,
full-time employees
receive:
Medical, Dental, Vision, Life, Disability coverage
20 days PTO + PTO rollover + 13 paid holidays
401(k)
Clinical Research Associate (CRA) - NC, VA, MD
Clinical research associate job in Raleigh, NC
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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers 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
Auto-ApplyClinical Research Associate
Clinical research associate job in Raleigh, NC
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
Essential Functions:
Responsible for conduct of all types of monitoring, and co-monitoring visits and associated monitoring activities for assigned clinical sites both in person, and remote. This includes evaluation, site initiation, interim and close out monitoring visits. Responsible for monitoring report writing and completion within required SOP and local regulatory parameters.
Ex-US: May be responsible for performing study start up activities in accordance with local practice, including site identification and feasibility activities, collection and preparation of site essential documents, Ethics Committee submissions, and other site set up activities.
Support development of study specific documentation related to monitoring activities as assigned. This includes but is not limited to monitoring trackers, clinical monitoring guidelines, clinical monitoring plan, source document templates, site tools, and worksheets, etc. Responsible for site personnel management and training on the protocol requirements, proper source documentation procedures compliance, and case report completion requirements.
Responsible for source document and case report forms review for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.
Managing, preparing, sending, tracking, and returning investigational supplies as assigned. Includes monitoring and documenting investigational supplies dispensing, inventory, and reconciliation.
Monitoring assigned clinical trials and clinical sites by reviewing and reporting site enrollment, and termination updates, monitoring visits, protocol deviations, serious adverse events, laboratory abnormalities and any other activity at the site that contributes to proper conduct of the clinical trial per protocol, and regulatory requirements.
Responsible for review and oversight of regulatory documentations for accuracy, completeness, and supporting assigned clinical sites with any regulatory concerns as appropriate.
Responsible for consistent and timely communication with assigned clinical sites, investigators, site personnel, client personnel, and any other cross functional team member involved in the assigned clinical trials to address any study needs related to the monitoring and site management activities as assigned.
Participate in meetings and conference calls with internal project teams, Sponsor teams, and any external partners working on execution of the assigned clinical trial.
Other duties as assigned.
Necessary Skills and Abilities:
Excellent verbal, written communication skills and interpersonal and presentation skills are .
Excellent computer skills with experience using Microsoft Office (Outlook, Word, Excel, and Power Point) applications to prepare charts, tables, forms, reports, and presentations .
Electronic data capture (EDC), CTMS, IVRS, and eTMF experience .
Knowledge of applicable local law, local regulatory requirements and regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision.
Must be able to offer solutions when obstacles are identified and train as necessary to achieve project goals.
Must have a general understanding of routine project goals from an organizational perspective.
Strong organizational skills and attention to details required. Ability to prioritize and plan workload is essential.
Educational Requirements:
Bachelor's degree or equivalent combination of education and experience.
Experience Requirements:
At least 3 years of experience as a Clinical Research Associate.
Prior therapeutic experience with Alzheimer's or similar Neurological/CNS therapeutic expertise.
#LI-JH1#LI-REMOTE
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
Auto-ApplyClinical Research Associate (CRA) - NC, VA, MD
Clinical research associate job in Raleigh, NC
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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers 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
Auto-ApplyClinical Research Associate (CRA) - NC, VA, MD
Clinical research associate job in Cary, NC
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
Senior Clinical Research Coordinator
Clinical research associate job in Chapel Hill, NC
Flexible work arrangements, including virtual/hybrid work locations, are an integral part of the School of Medicine's Working Forward initiative. As such, this position's work location is designated as hybrid. Please note that the designated work location is subject to change based on the unit's business needs. This position will serve as a Senior Clinical Research Coordinator within the Department of Urology. The Senior Clinical Research Coordinator is responsible for the planning, organization, conduct, and evaluation of multi-faceted clinical research protocols, including study execution, developing strategies and solutions to improve study processes and execution, providing reviews of other team members' work product, and serving as mentor and subject matter expert.
Required Qualifications, Competencies, And Experience
Strong written and verbal communication skills. Must be able to work and communicate with diverse populations effectively and professionally. Ability to work independently as well as function as part of a team. Proficient with Microsoft Outlook, Excel, and Word. Basic working knowledge of research in the area of assignment, retrieval of data/information, working within established deadlines, and working with a project of limited scope and complexity.
Preferred Qualifications, Competencies, And Experience
Experience with methods and Good Clinical Practice used in data collection, patient facing enrollment and consent, intervention dissemination, data entry in sponsor EDC platforms, screening for patient enrollment in EPIC , and database storage and management. Manage all regulatory study tasks within IRBIS , the Protocol Review Committee ( PRC ), including initial submission, renewals, and modifications. Collaborate with department finance director and OnCore affiliates to ensure timely sponsor invoicing and payments, along with trial patient compensation. Training in CITI's Human Subject Research curriculum. Optimal experience would include experience in OnCore, REDCap, EPIC , IRBIS , as well as past collaboration with OCT , PRC , and other related UNC clinical trials regulatory offices.
Clinical Studies Coordinator II, Cardiology Research
Clinical research associate job in Wake Forest, NC
Department:
36962 Wake Forest University Health Sciences - Cardiology: Adult
Status:
Full time
Benefits Eligible:
Yes
Hours Per Week:
40
Schedule Details/Additional Information:
Full time- On site position
Pay Range
$26.10 - $39.15
Under departmental direction, coordinates activities to support multiple research studies of all phases. Serves as the principal administrative liaison for assigned studies with the ability to manage a workload that includes studies of increased complexity. Develops and maintains recordkeeping systems and procedures to ensure compliance with study protocols and all appropriate regulations. Attends clinic as needed to perform activities including, but not limited to: assist the research team with recruitment activities, administer questionnaires and answer any questions about future appointments. Responsible for the compilation, registration and submission of data, as required by the Sponsor.
EDUCATION/EXPERIENCE
Bachelor's degree with two years; experience in clinical research; or an equivalent combination of experience and education.
LICENSURE, CERTIFICATION, and/or REGISTRATION
SOCRA or ACRP Certification preferred.
Must complete the CITI certification for Human Subject Research if not already completed.
All additional required WakeOne training for research coordinators.
ESSENTIAL FUNCTIONS
1. Works under the direction of the Study Investigators or Clinical Research Nurse Manager with minimal supervision.
2. Plays an active role in recruitment of patients to study.
3. Performs protocol specific duties required per the research protocol.
4. Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families.
5. Fulfills sponsor requirements related to reportable information including adverse events, unanticipated problems, and other information required by the sponsor protocol.
6. Abstracts data from the medical record and completes paper and electronic case report forms, including responding to any requests for data clarification, and maintains all necessary source documents.
7. Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner.
8. Provides staff relief as required to meet the needs of the department. Participates in scheduled team/department meetings. Participates in quality improvement projects on an on-going basis.
9. May mentor new and less experienced staff.
10. Follows established Wake Forest Baptist and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
11. Performs other related duties as assigned or requested.
SKILLS/QUALIFICATIONS
Excellent interpersonal, oral, and written communication skills
Excellent reading comprehension
Strong organizational skills EPIC/WakeOne proficiency to include appropriate documentation of research notes
Proficient in the use of OnCore/WISER Clinical Trial Management System
Basic computer skills
Fosters/promotes a positive image and professional appearance
Sensitivity to intercultural relations
Sensitivity to the maintenance of confidentiality
Knowledge of Microsoft Products
WORK ENVIRONMENT
Clean, comfortable, office environment
Our Commitment to You:
Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including:
Compensation
Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
Premium pay such as shift, on call, and more based on a teammate's job
Incentive pay for select positions
Opportunity for annual increases based on performance
Benefits and more
Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program
About Advocate Health
Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation's largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.
Auto-ApplyClinical Research Assistant
Clinical research associate job in Raleigh, NC
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference
The Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization.
How You'll Make An Impact
* Ability to understand and follow institutional SOPs
* Participate in recruitment and pre-screening events (may be at another location)
* Assist with preparation of outreach materials
* Identify potential participants by reviewing medical records, study charts and subject database
* Assist with recruitment of new participants by conducting phone screenings
* Request medical records of potential and current research participants
* Schedule visits with participants, contact with reminders
* Obtain informed consent per Care Access Research SOP, under the direction of the CRC
* Complete visit procedures as required by protocol, under the direction of the CRC
* Collect, process and ship specimens as directed by protocol, under the direction of the CRC
* Record data legibly and enter in real time on paper or e-source documents
* Request study participant payments
* Update all applicable internal trackers and online recruitment systems
* Assist with query resolution
* Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc.
* Assist with maintaining all site logs
* Assist with inventory and ordering equipment and supplies
* Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
* Maintain effective relationships with study participants and other care Access Research personnel.
* Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management.
* Communicate clearly verbally and in writing.
* Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
The Expertise Required
* Ability and willingness to work independently with minimal supervision
* Ability to learn to work in a fast-paced environment
* Excellent communication skills and a high degree of professionalism with all types of people
* Excellent organizational skills with strong attention to detail
* A working knowledge of medical and research terminology
* A working knowledge of federal regulations, Good Clinical Practices (GCP)
* Critical thinker and problem solver
* Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
* Contribute to team and site goals
* Proficiency in Microsoft Office Suite
* High level of self-motivation and energy
* An optimistic, "can do" attitude
Certifications/Licenses, Education, and Experience:
* A minimum of 1-year recent working experience as a Medical Assistant, EMT, LPN, Clinical Research Assistant or Phlebotomist.
* Phlebotomy Experience and Proficiency Required
* Some Clinical Research experience preferred
* California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health
* Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners
* Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health
* Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health
How We Work Together
* Location: This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal (
* Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $19.00-$33.00 USD per hour. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off.
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
Clinical Research Coordinator
Clinical research associate job in Raleigh, NC
M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.
Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.
Due to our continued growth, we are hiring for a Clinical Research Coordinator at Wake Research, an M3 company. This position is on-site and located in Raleigh, NC.
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Essential Duties and Responsibilities:
Assisting trial Investigator in screening and review of potential study participants eligibility
Maintaining case report forms, charts and documentation
Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants
Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements
Collecting and entering data as necessary
Assist management with potential new hire selection and shadowing process
Assist with study start-up, maintenance, and close-out of studies as needed for those on the team
Ability to be flexible with study assignments
Qualifications
Clinical Research Coordinator with 1-2 years of experience
Phlebotomy experience is highly preferred
Previous experience as a medical assistant, LPN, or RN
Excellent verbal & written communication skills
Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking
Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines
Extensive clinical trial knowledge through education and/or experience
Successful completion of GCP Certification and Advanced CRC preferred
Detail-oriented
Familiarity with the Code of Federal Regulations as they pertain to human subject protection
Strong interpersonal skills
Additional Information
About M3:
M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.
Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.
Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.
Benefits:
A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:
401(k), 401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance
*M3 reserves the right to change this job description to meet the business needs of the organization
#LI-Onsite
#LI-LB1
Clinical Research Coordinator
Clinical research associate job in Raleigh, NC
M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.
Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.
Due to our continued growth, we are hiring for a
Clinical Research Coordinator
at
Wake Research,
an M3 company. This position is on-site and located in
Raleigh, NC
.
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Essential Duties and Responsibilities:
Assisting trial Investigator in screening and review of potential study participants eligibility
Maintaining case report forms, charts and documentation
Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants
Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements
Collecting and entering data as necessary
Assist management with potential new hire selection and shadowing process
Assist with study start-up, maintenance, and close-out of studies as needed for those on the team
Ability to be flexible with study assignments
Qualifications
Clinical Research Coordinator with 1-2 years of experience
Phlebotomy experience is highly preferred
Previous experience as a medical assistant, LPN, or RN
Excellent verbal & written communication skills
Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking
Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines
Extensive clinical trial knowledge through education and/or experience
Successful completion of GCP Certification and Advanced CRC preferred
Detail-oriented
Familiarity with the Code of Federal Regulations as they pertain to human subject protection
Strong interpersonal skills
Additional Information
About M3:
M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.
Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.
Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.
Benefits:
A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:
401(k), 401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance
*M3 reserves the right to change this job description to meet the business needs of the organization
#LI-Onsite
#LI-LB1
Clinical Research Coordinator (Onsite Dallas, TX)
Clinical research associate job in Morrisville, NC
Illingworth Research Group provides a range of patient focused clinical services to the pharmaceutical, healthcare, biotechnology and medical device industries. These include mobile research nursing, patient concierge, medical photography and clinical research services. Illingworth are experts with experience across all study phases and in a diverse range of therapeutic areas.
Illingworth Research Group is a global organization operating in over 45 countries, bringing clinical research directly into the home of the patient, to improve the experience of patients involved in clinical trials and the quality of their lives.
Job Responsibilities
Clinical Research Project Planning and Preparation
Review of assigned protocols and other protocol documentation (ICF, IB) for accuracy, feasibility,
timing, and resources.
Prepare and maintain the Investigator Site File and/ or Trial Master File (TMF) for the study.
Participate in creation and review of timelines and start-up meetings (Investigator Meeting/SIV,
Sponsor discussions, or other related meetings).
Take the lead and/or overall coordination of all required start-up activities including, but not
limited, to the following:
o Clinic logistics planning, schedule of clinic activities, and team training.
o Preparation, review, and/or finalization of clinic source documents, time and events
tables, and other required study materials; review of Case Report Forms (CRFs),
laboratory workbooks, staff requirements, and schedules.
o In collaboration with the responsible teams, establishes and/or maintains safety
assessment requirements, Quality Control (QC) and monitoring plans,
pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other
elements as applicable to the study.
o Confirms all required regulatory and contractual documentation is present prior to study
start.
Support the Principal Investigator as needed with study related tasks such as, but not limited to:
o Delegation of Authority Log.
o Management of daily tasks.
o Visit calendar development and maintenance.
o Scheduling and attending monitor visits.
Advertise, recruit, and screen potential participants for the study.
Clinical Conduct
Perform all study activities following Good Clinical Practices (GCP).
Manage multiple clinical trials simultaneously.
Protect the safety of human subjects.
Monitor appropriate sources for specific clinical study or federal regulation updates.
Collect and enter study data into the appropriate system.
Coordinate and monitor screening activities; provides support as required.
Assist with informed consent of study subjects.
Submit data in required timeframe.
Monitor appropriate sources for specific clinical study or federal regulation updates.
Complete Case Report Forms.
Facilitate audits of study data.
Develop patient rapport to explain research protocols and minimize protocol violations.
Develop rapport with study team to educate team on study procedures and minimize protocol
violations.
Respond to inquiries by auditors for data clarification or additional data in required timeframe.
Take the lead and/or overall coordination of clinic activities including, but not limited to:
o Supervises clinic visits (admission, dosing and randomization, discharge, and follow-up)
as required and provides on-call support when applicable.
o Screens eligibility prior to randomization; oversees, coordinates and/ or performs study
drug administration, and other activities as delegated and required.
o In collaboration with the responsible teams, monitors that all study-related activities are
conducted according to protocol, SOP, and applicable regulations.
Review and manage clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs)
reporting, study logs and tracker, quality control, and Monitor findings.
Post-Clinic/Close-Out Activities
Coordinate resolution and/or address QC, monitor, CRF, or other internal/external findings.
Review and/or oversee close-out of study documentation, deviation reporting, CRF completion
and sign-off, and other study-related reports/documentation.
Review and update TMF documentation.
Finalize study and/or volunteer logs.
Ensure completion of other close-out activities as required (return of study supplies, IRB reports,
archiving, etc.).
Responsible for monitoring subjects' compliance throughout the trial and address day-to-day.
subject or study issues and escalate as appropriate.
Prepare for and participates in sponsor/monitor/QA audits.
Provide accurate and timely project status updates to Project Managers and sponsor.
Collaborate within and between teams during process improvement exercises, SOP creation.
and/or revision, internal and external meetings, and other company-related initiatives and goals.
Accommodate flexible schedule (available days, afternoons, nights, and weekends).
Perform other work-related duties as assigned.
Coordinate and Perform Regulatory Activities
Maintain proper protocol, consent, amendment, and yearly renewal submission if requested.
Report adverse events relating to the trial.
Maintain study files.
Travel up to 100%
QUALIFICATION REQUIREMENTS
Registered Nurse and/ or University Degree such as Bachelor of Science Degree required.
Clinical Research certification preferred.
A minimum of 1 year experience in clinical research required, preferably in coordination of clinical
research projects. 2+ years preferred.
Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines.
Required skills: problem solving, planning, and evaluation.
Possess good time management, detail-oriented, and able to multi-task.
Good interpersonal and communication skills with a team focus.
Knowledge of SOP writing.
Ability to anticipate problems and provide solutions in a timely manner.
Ability to coordinate multiple clinical research projects with competing deadlines.
Proficiency in computer software programs (e.g. Word, Excel, Power Point).
Proficiency in use of various clinical trial EDC software preferred.
Disclaimer:
Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its
sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents
may differ from those listed in the . The Company, at its sole discretion, will determine
what constitutes as equivalent to the qualifications described above. Further, nothing contained herein
should be construed to create an employment contract. Occasionally, required skills/experiences for jobs
are expressed in brief terms. Any language contained herein is intended to fully comply with all
obligations imposed by the legislation of each country in which it operates, including the implementation
of the EU Equality Directive, in relation to the recruitment and employment of its employees. The
Company is committed to compliance with the Americans with Disabilities Act, including the provision of
reasonable accommodations, when appropriate, to assist employees or applicants to perform the
essential functions of the job.
We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
Additional Information:
Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Coordinates or co-leads assigned clinical research projects in accordance with Protocols, Standard Operating Procedures (SOPs), and applicable regulations.
Social/Clinical Research Assistant
Clinical research associate job in Chapel Hill, NC
A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.
One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.
University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.
Primary Purpose of Organizational Unit
Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education and research.
Patient care: We promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.
Education: We prepare tomorrow`s healthcare professionals and biomedical researchers from all backgrounds by facilitating learning within innovative and integrated curricula and team-oriented interprofessional education to ensure a highly skilled workforce.
Research: We develop and support a rich array of outstanding health sciences research programs, centers and resources. We provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our university to support outstanding research. We foster programs in the areas of basic, translational, mechanistic and population research.
Position Summary
This position will serve as an Associate Clinical Research Coordinator within the Department of Anesthesiology Research The Associate Clinical Research Coordinator is responsible for the execution of clinical research protocols, including leading efforts in gathering, compiling, and reporting data for a variety of research studies.
Minimum Education and Experience Requirements
Bachelor's degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
Required Qualifications, Competencies, and Experience
Must be able to use considerable judgement and skills in performing work assignments. Strong written and verbal communication skills. Must be able to work and communicate with diverse populations effectively and professionally. Ability to work independently as well as function as part of a team. Proficient with Microsoft Outlook, Excel, and Word.
Must have research experience.
Preferred Qualifications, Competencies, and Experience
Prefer experience as a Lead Coordinator for a study.
Required Licenses/Certifications Special Physical/Mental Requirements Campus Security Authority Responsibilities
Not Applicable.
Position/Schedule Requirements Evening work occasionally, Weekend work occasionally Special Instructions Quick Link *******************************************
Study Coordinator
Clinical research associate job in Chapel Hill, NC
The UNC LCCC Cellular Therapy Program (************************************************** is seeking a study coordinator to facilitate complex investigational and FDA -approved cellular and gene therapies within according to federal regulations, Good Clinical Practice, and local and institutional policies. This position will ensure that patients who are being evaluated for and undergoing cell therapy receive comprehensive, coordinated care in an organized and high-quality manner. The study coordinator will work with a multi-disciplinary team of pre-clinical faculty, clinical faculty, and UNC Medical Center staff to design, develop and deliver investigational and/or FDA -approved cellular and gene therapies to adult and pediatric populations. This position will coordinate the conduct of early phase cellular and gene therapy clinical trials, including patient and data management. The coordinator will maintain the quality of research by addressing patient safety and regulatory compliance.
Required Qualifications, Competencies, And Experience
Strong written and verbal communication skills. Must be able to work and communicate with diverse populations effectively and professionally. Ability to work independently as well as function as part of a team. Proficient with Microsoft Outlook, Excel, and Word. Knowledge of GCP and ICH Guidelines and ability to follow established regulations, procedures, and protocols. Previous study coordinator or patient navigation experience. High level of accuracy and attention to detail. Ability to plan work and coordinate multiple projects. Strong attention to detail and accuracy; excellent organization skills. Experience navigating medical records and data extraction.
Preferred Qualifications, Competencies, And Experience
Research Certification - SOCRA / ACRP Experience in early phase interventional clinical research Experience in oncology
Work Schedule
Monday - Friday, 8:00am - 5:00pm
Central Study Coordinator - Brazil
Clinical research associate job in Raleigh, NC
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
The Central Study Coordinator position is responsible for the coordination and support of remote site activities for assigned projects.
Essential Job Functions:
Serve as point of contact for day-to-day Site communications, document submissions and activity coordination.
Support pre-screening, screening and recruitment activities, as assigned.
Responsible for subject re-consenting, acquiring medical records, conducting protocol activities, as directed by the Principal Investigator.
Perform data-entry, evaluate and respond to system queries and monitor clinical databases as assigned.
Establish and maintain timely Site communication as assigned.
Maintain documentation which complies with IRB/FDA policies.
Assist with study closeout.
Assist site with other study-related activities as directed.
Other duties as assigned.
Ability to manage technology and web-based research platforms on PC (Microsoft OS) laptop in the remote workspace.
Study Tearn experience is ideal.
Critical thinking skills.
Strong communication Skills (verbal and written).
Ability to work independently, and collaboratively with other CSCs to delegate tasks as needed.
Working location that has the ability to maintain privacy.
Current knowledge of and the ability to apply ICH / GCP and applicable regulations and guidelines.
Competent in the application of standard business procedures including but not limited to SOPs, global regulations.
Well organized and able to multitask.
Able to work independently and as a team member.
Able to take initiative while following directives.
Educational Requirement:
Bachelor's degree or equivalent experience defined as a minimum of 2 years related, combined experience in education, knowledge and skills that will allow one to perform the tasks of the role proficiently.
#LI-Remote
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
Auto-ApplyClinical Studies Coordinator I, Internal Medicine
Clinical research associate job in Wake Forest, NC
Department:
38105 Wake Forest University Health Sciences - Department: Internal Medicine
Status:
Full time
Benefits Eligible:
Yes
Hours Per Week:
40
Schedule Details/Additional Information:
Monday-Friday 8 to 5
Pay Range
$23.65 - $35.50
JOB SUMMARY
Under general supervision, responsible for the compilation and collection of data, recruitment of subjects, and general coordination of clinical studies.
EDUCATION/EXPERIENCE
Bachelor's degree in a related field of study or an equivalent combination of experience and education.
At least one years' experience in a medical and/or research setting. Specifically seeking experience recruiting and consenting research participants.
Paramedical or other clinical experience.
LICENSURE, CERTIFICATION, and/or REGISTRATION
Registered Record Administrator preferred.
ESSENTIAL FUNCTIONS
1. Assists principal investigator and other health professionals in troubleshooting various problems related to the management of the clinical study. Assists in all aspects of the data collection process.
2. Performs technical procedures on clinical subjects under the direction of the principal investigator or his/her designee.
3. Assists with recruitment of patients for the clinical study including tracking the sources of patient referrals. Follow-up with sources of patient referrals including referring doctors, various Medical Center labs, and other sources.
4. Maintains appropriate patient records as necessary. This includes charting the condition of the patient and determining their continued eligibility in the study.
5. Obtains and interprets pertinent data from medical records as needed to understand past and present condition of the patients.
6. Performs day-to-day administrative and clerical duties such as designing brochures, stationary and data forms. Creates reports and graphs pertinent to the study including presentation of the results of the study.
7. May supervise other personnel including volunteers as assigned.
8. Assists in development of suitable codes and data collection forms for computerization.
9. Consults and cooperates with all faculty, coordination centers, sponsors, and health professionals involved in the clinical study.
10. Performs other related duties incidental to the work described herein.
SKILLS/QUALIFICATIONS
Understanding of medical and/or scientific terminology
Strong oral, written, and interpersonal communication skills
WORK ENVIRONMENT
Clean, well-lit, office environment
Our Commitment to You:
Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including:
Compensation
Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
Premium pay such as shift, on call, and more based on a teammate's job
Incentive pay for select positions
Opportunity for annual increases based on performance
Benefits and more
Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program
About Advocate Health
Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation's largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.
Auto-ApplyClinical Research Assistant
Clinical research associate job in Raleigh, NC
Job Description
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like
Future of Medicine
, which makes advanced health screenings and research opportunities accessible to communities worldwide, and
Difference Makers
, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference
The Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization.
How You'll Make An Impact
Ability to understand and follow institutional SOPs
Participate in recruitment and pre-screening events (may be at another location)
Assist with preparation of outreach materials
Identify potential participants by reviewing medical records, study charts and subject database
Assist with recruitment of new participants by conducting phone screenings
Request medical records of potential and current research participants
Schedule visits with participants, contact with reminders
Obtain informed consent per Care Access Research SOP, under the direction of the CRC
Complete visit procedures as required by protocol, under the direction of the CRC
Collect, process and ship specimens as directed by protocol, under the direction of the CRC
Record data legibly and enter in real time on paper or e-source documents
Request study participant payments
Update all applicable internal trackers and online recruitment systems
Assist with query resolution
Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc.
Assist with maintaining all site logs
Assist with inventory and ordering equipment and supplies
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
Maintain effective relationships with study participants and other care Access Research personnel.
Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management.
Communicate clearly verbally and in writing.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
The Expertise Required
Ability and willingness to work independently with minimal supervision
Ability to learn to work in a fast-paced environment
Excellent communication skills and a high degree of professionalism with all types of people
Excellent organizational skills with strong attention to detail
A working knowledge of medical and research terminology
A working knowledge of federal regulations, Good Clinical Practices (GCP)
Critical thinker and problem solver
Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
Contribute to team and site goals
Proficiency in Microsoft Office Suite
High level of self-motivation and energy
An optimistic, "can do" attitude
Certifications/Licenses, Education, and Experience:
A minimum of 1-year recent working experience as a Medical Assistant, EMT, LPN, Clinical Research Assistant or Phlebotomist.
Phlebotomy Experience and Proficiency Required
Some Clinical Research experience preferred
California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health
Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners
Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health
Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health
How We Work Together
Location: This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal (
Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $19.00-$33.00 USD per hour. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off.
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
Site Management Associate I / Clinical Research Lead Assistant
Clinical research associate job in Raleigh, NC
Clinical Research Lead Assistant - Pacific time
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
Demonstrate proficiency in various Microsoft applications (e.g., Word, Excel, PowerPoint, SharePoint, Lists, Forms, etc.)
Coordinate and schedule internal and external meetings
Provide administrative support for clinical trials/to Investigator Engagement (e.g., data entry, troubleshooting, etc.)
Support retention-related activities by liaising with sites to address high-risk participants
Administrative support for clinical trials as required - (eg: filing, collection of signatures, invoice reconciliation)
Document Management - (eg: scan, fax, upload, eTMF maintenance activities)
In-house administrative support for Site CDCs (eg: CDA creation/follow-up)
Support Investigator Engagement business systems and process as required
Internal and External meeting support
As applicable, SIP Support for Investigator Engagement:
Support retention-related activities including calls with Medical/National Leaders or for Enrollment Support
Data entry of Vault Clinical Enrollment Metrics
Collate reports/key information in preparation for site discussions/visits
Troubleshoot platform issues related to DCT/referral capabilities (e.g., Florence, StudyTeam, etc.)
Submit PO increases & support external customer interactions
Tracking Diversity to help us make informed decisions for pivoting where needed & Community Outreach Requests Coordination
Coordinate IE Site Visit Requests across Therapeutic Areas
You are:
Knowledge of Good Documentation Practices
Excellent computer skills with experience in a variety of software packages
Fluency in English both written and oral.
High level of attention to detail
Strong self-management, communication and organizational skills
Flexibility
Excellent problem solving skills
Ability to work in a virtual team and across cultures
Located in the Pacific time zone area
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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers 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
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