Clinical Trial Manager
Clinical research coordinator job in Raleigh, NC
Key Responsibilities:
Lead and manage operational aspects of global clinical trials from study start-up through close-out
Oversee study timelines, deliverables, and budgets to ensure milestones are met
Coordinate with cross-functional teams, external vendors, and CROs to ensure high-quality study conduct
Oversee site activation, clinical monitoring, data integrity, and adherence to protocol
Conduct study-level risk assessments and ensure inspection readiness
Manage safety and pharmacovigilance activities in collaboration with internal and external teams
Lead internal and external study meetings; provide training to relevant stakeholders
Contribute to the development of study-related documents and clinical study reports
Perform other duties as needed to support successful trial execution
Qualifications:
Bachelor's degree in life sciences or a related (advanced degree preferred)
Minimum of 8 years of clinical trial management experience, particularly in respiratory trials or pediatric studies
Demonstrated success in leading global trials and working with cross-functional and vendor teams
Deep understanding of GCP, ICH guidelines, and global regulatory requirements
Specific therapeutic experience in respiratory diseases, especially COPD, strongly preferred
Strong project management, problem-solving, and communication skills
Proficiency in using clinical trial systems (e.g., eTMF, EDC), Microsoft Office, and Excel
Clinical Research Coordinator 247698
Clinical research coordinator job in Cary, NC
Clinical Trial Coordination
Coordinate and manage all aspects of assigned clinical trials from site initiation to close-out.
Conduct study visits, including obtaining informed consent, performing protocol-required procedures, and collecting source data using eSource systems.
Ensure timely and accurate entry of study data into electronic case report forms (eCRFs).
Technology & Documentation
Utilize eSource, eConsent, eISF, and other clinical trial software platforms to maintain complete, accurate, and regulatory-compliant study records.
Support site readiness and compliance
Regulatory Compliance
Maintain up-to-date regulatory documents and study binders (electronic and/or paper as required).
Assist with preparation for sponsor, CRO, or regulatory audits.
Patient Engagement & Safety
Recruit, screen, and enroll study participants according to protocol inclusion/exclusion criteria.
Ensure ongoing patient safety by monitoring for adverse events and reporting per protocol.
Execute phlebotomy
Collaboration & Support
Serve as the primary point of contact for sponsors, CROs, monitors, and other site staff.
Support training and mentoring of new CRC staff as assigned.
Clinical Research Associate (CRA) - NC, VA, MD
Clinical research coordinator 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) - NC, VA, MD
Clinical research coordinator 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 coordinator 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)
Clinical research coordinator 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
Clinical research coordinator 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 required.
Excellent computer skills with experience using Microsoft Office (Outlook, Word, Excel, and Power Point) applications to prepare charts, tables, forms, reports, and presentations required.
Electronic data capture (EDC), CTMS, IVRS, and eTMF experience required.
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 coordinator 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 coordinator 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.
Research Study Coordinator
Clinical research coordinator 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 that include numerous retail and restaurant discounts, savings on local child care centers and special rates for performing arts events.
Primary Purpose of Organizational Unit
The UNC Adams School of Dentistry Department of Pediatric Dentistry and Dental Public Health provides oral health care for individuals from infancy through adolescence and promotes prevention of oral disease. The Pediatric Dentistry discipline is committed to high-quality care for children, adolescents, and individuals with special healthcare needs while balancing teaching, scholarship, research, patient care, and professional service.
Position Summary
The Research Study Coordinator will support multiple clinical-translational research studies focused on pediatric orofacial pain. Core responsibilities include participant recruitment, scheduling, and conducting study visits involving pain and behavioral assessments, patient-reported outcomes, and data collection. This position will also assist with data entry, quality control, and basic data management, with opportunities to learn how to create tables and figures for abstracts, presentations, and manuscripts. The role requires frequent patient and family interaction, as well as communication with dental and medical professionals. The ideal candidate will demonstrate strong attention to detail, professionalism, reliability, and the ability to follow detailed protocols. They must be highly organized, able to work independently, and comfortable collaborating within a multidisciplinary team and in patient-facing settings.
Minimum Education and Experience Requirements
Demonstrated possession of the competencies necessary to perform the work.
Required Qualifications, Competencies, and Experience
Experience in a clinical research environment; ability to observe, monitor, collect, and record data with attention to accuracy, validity, and integrity; strong communication and organizational skills; and comfort working directly with pediatric participants and their families.
Preferred Qualifications, Competencies, and Experience
Course work in a biomedical, behavioral, or related field; previous experience working with children or families; familiarity with clinical-translational research or human subjects research; and proficiency with REDCap or similar data management systems.
Special Physical/Mental Requirements Campus Security Authority Responsibilities
Not Applicable.
Special Instructions Quick Link ******************************************* Temporary Employment Policies
Temporary Employment Policies
Clinical Studies Coordinator II, Nephrology
Clinical research coordinator job in Wake Forest, NC
Department:
38922 Wake Forest University Health Sciences - Nephrology
Status:
Full time
Benefits Eligible:
Yes
Hours Per Week:
40
Schedule Details/Additional Information:
Monday- to Friday 8am - 5pm
Pay Range
$26.10 - $39.15
JOB SUMMARY
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 Coordinator
Clinical research coordinator job in Raleigh, NC
Piper Companies is seeking a detail-oriented and proactive Clinical Research Coordinator (CRC) to join our growing clinical research team. The ideal candidate will have hands-on phlebotomy experience and a strong background working within a clinical site network environment. This role is essential in supporting the execution of clinical trials across multiple therapeutic areas.
Responsibilities for the Clinical Research Coordinator:
* Coordinate and manage day-to-day clinical trial activities in compliance with GCP, IRB, and protocol requirements
* Perform phlebotomy and process biological specimens per protocol
* Schedule and conduct study visits, including informed consent, data collection, and subject follow-up
* Maintain accurate and timely documentation in source documents and electronic data capture (EDC) systems
* Collaborate with sponsors, CROs, and site network teams to ensure protocol adherence and data integrity
* Assist with regulatory submissions, monitoring visits, and audit preparation
* Support subject recruitment, screening, and retention strategies
Qualifications for the Clinical Research Coordinator:
* Bachelor's degree in a health-related field or equivalent experience
* 2-4 years of experience as a CRC or similar role in a clinical site network
* Certified or trained in phlebotomy with proven venipuncture skills
* Strong knowledge of ICH-GCP, FDA regulations, and clinical trial workflows
* Proficient in EDC systems, CTMS, and Microsoft Office Suite
* Excellent communication, organizational, and multitasking skills
Compensation for the Clinical Research Coordinator:
* Salary Range: $55,000-$70,000
* Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays
Clinical Research Coordinator, RN
Clinical research coordinator job in Raleigh, NC
Full-time Description
Clinical Research Coordinator, RN's are primarily responsible for study coordination and data management, with a central focus on managing subject recruitment and enrollment, consistency of study implementation, data management and integrity, and compliance with regulatory requirements and reporting.
Requirements
ESSENTIAL JOB FUNCTION/COMPETENCIES
The responsibilities and duties described in this job description are intended to provide a general overview of the position. Duties may vary depending on the specific needs of the affiliate or location you are working at and/or state requirements. Responsibilities include but are not limited to:
Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner.
Educates and directs protocol compliance with physicians and staff.
Assists in developing tools to meet requirements of new protocols.
Manages protocols with increased clinical complexities including translational investigator-initiated research as well as multi center trials.
Ensure good documentation practices are applied by all team members when collecting, maintaining, and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms.
Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
Acts as a patient advocate by providing education to and responding to questions from patients about protocols.
Works with patients to ensure adherence with the protocol.
Collaborates with scheduling staff to assure that future appointments for the patients (follow up visits and diagnostic testing) are scheduled correctly and timely.
Collaborates with the physician to assure orders for treatment are written per protocol and delivered at the prescribed protocol intervals.
Performs other position related duties as assigned.
Employees shall adhere to high standards of ethical conduct and will comply with and assist in complying with all applicable laws and regulations. This will include and not be limited to following the Solaris Health Code of Conduct and all Solaris Health and Affiliated Practice policies and procedures; maintaining the confidentiality of patients' protected health information in compliance with the Health Insurance Portability and Accountability Act (HIPAA); immediately reporting any suspected concerns and/or violations to a supervisor and/or the Compliance Department; and the timely completion the Annual Compliance Training.
CERTIFICATIONS, LICENSURES OR REGISTRY REQUIREMENTS
BLS certification required, ACLS preferred.
RN licensure and certifications as required by State.
Clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) preferred.
KNOWLEDGE | SKILLS | ABILITIES
Ability to Start IVs and Administer IV medications
Ability to draw blood
Understanding of all aspects of biomedical research protocols, ensuring applicable regulations, and guidelines.
Maintains patient confidentially.
Excellent verbal and written communication skills.
Skill in using computer programs and applications.
Maintains current knowledge and awareness of organizational and regulatory standards, policies and procedures.
Excellent organizational skills and attention to detail.
Ability to build relationships with patients and display empathy and compassion to patients
Skill in using computer programs and applications including Microsoft Office.
Complies with HIPAA regulations for patient confidentiality.
Complies with all health and safety policies of the organization.
EDUCATION REQUIREMENTS
Must be a Registered Nurse (RN) with a current and valid license. Associate's or Bachelor's degree in Nursing (ASN or BSN) required.
EXPERIENCE REQUIREMENTS
2 or more years Nursing experience in ICU, ER, oncology or clinical trial experience, preferred.
REQUIRED TRAVEL
May require travel to other site locations in practice.
May require travel to Investigator and other meetings.
PHYSICAL DEMANDS
Carrying Weight Frequency
1-25 lbs. Frequent from 34% to 66%
26-50 lbs. Occasionally from 2% to 33%
Pushing/Pulling Frequency
1-25 lbs. Seldom, up to 2%
100 + lbs. Seldom, up to 2%
Lifting - Height, Weight Frequency
Floor to Chest, 1 -25 lbs. Occasional: from 2% to 33%
Floor to Chest, 26-50 lbs. Seldom: up to 2%
Floor to Waist, 1-25 lbs. Occasional: from 2% to 33%
Floor to Waist, 26-50 lbs. Seldom: up to 2%
Version 6.2.25
Clinical Research Coordinator (Onsite Dallas, TX)
Clinical research coordinator 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.
Clinical Research Coordinator
Clinical research coordinator 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 coordinator 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
Central Study Coordinator - Mexico
Clinical research coordinator 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 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.
Necessary Skills and Abilities:
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 Requirements:
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-ApplyStudy Coordinator
Clinical research coordinator 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 plays a pivotal role in advancing cancer research and improving patient outcomes by facilitating the conduct of oncology clinical trials in compliance with federal regulations, Good Clinical Practice, and institutional policies. This position independently manages multiple complex trials throughout their life cycle, including activation, implementation, and closure, under the direction of a Clinical Operations Manager.
Key responsibilities include:
* Recruitment, consent, and enrollment of study participants
* Coordination of study visits across various clinic settings
* Documentation of procedures and visits, facilitation of sample collection, and data entry
* Collaboration with research teams to ensure regulatory compliance and patient safety
This position is integral to the mission of the UNC/LCCC Clinical Trials Office, maintaining research quality and safeguarding institutional integrity, and driving discoveries that shape the future of cancer care.
Minimum Education and Experience Requirements
Bachelor's degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
Required Qualifications, Competencies, and Experience
* Knowledge of ICH GCP, Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols
* Strong computer skills
* Ability to gather data and document procedures
High level of accuracy and attention to detail,
* Ability to plan work and coordinate multiple projects
* Possess strong decision making and problem-solving skills
* Customer oriented and ability to work in a team environment
* Ability to communicate effectively and professionally verbally and in writing.
* Requires study coordinator experience or experience in oncology clinical trials
Ability to work on site at UNC Medical Center, UNC Chapel Hill Campus, and any satellite clinic site where trials are conducted.
Ability to work on evenings, weekends and/or holidays occasionally required.
Preferred Qualifications, Competencies, and Experience
Previous experience with therapeutic clinical research involving drugs and/or devices
Experience with direct patient contact in the hospital/clinic setting
SOCRA/ACRP Certification
Experience in Phase I, II, and III clinical research.
Experience or familiarity with medical terminology, navigation of medical records and data abstraction
Prior experience with translational science research projects
Demonstrated ability to operate at a high degree of independence
Demonstrated ability to coordinate studies of high complexity
Required Licenses/Certifications Special Physical/Mental Requirements Campus Security Authority Responsibilities
Not Applicable.
Position/Schedule Requirements Clinic - UNCH or ACC, Evening work occasionally, Exposure to Bloodborne Pathogens, Exposure to Hazardous Materials, Laboratory, Overtime occasionally, Patient care involved, Weekend work occasionally Special Instructions Quick Link *******************************************
Clinical Studies Coordinator I, Internal Medicine
Clinical research coordinator 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 Study Coordinator
Clinical research coordinator job in Chapel Hill, NC
Reporting to the Scientific Research Manager, this position is responsible for supporting the clinical activities on a variety of oncology research studies managed by the Translational Science and Health Services unit in the UNC Lineberger Comprehensive Cancer Center ( LCCC ) Clinical Trials Office. These activities include adhering to established timelines and standards, organizing meetings, facilitating communication between the study team, conducting patient screening and informed consents, HIPAA and patient follow-ups, managing documentation, specimen handling, data abstraction, and data entry. Adhering to GCP guidelines, this position ensures study compliance with all regulatory and ethical requirements, including IRB standards, and manages the documentation necessary to meet these standards. The ideal candidate will have strong analytical, organizational, and interpersonal skills, with a passion for contributing to research that drives meaningful change in healthcare outcomes.
Required Qualifications, Competencies, And Experience
Possess strong decision-making and task-prioritization skills; the ability to problem-solve and troubleshoot issues. High level of accuracy and attention to detail. Ability to thoroughly document procedures. Customer-oriented and team-oriented. Demonstrated ability to communicate professionally verbally and in writing. Experience using Microsoft Word, Excel & PowerPoint. Knowledge of ICH GCP , Federal Regulations and Guidelines. Demonstrated ability to plan work and coordinate multiple projects. Familiarity with software for data management, such as REDCap.
Preferred Qualifications, Competencies, And Experience
Some experience with direct patient contact in the hospital/clinic setting; preferably in a research context. Active CCRP / CCRC certification. Experience or familiarity with medical terminology, medical record chart review and data abstraction. Prior experience with translational science projects including standard operating procedures for biospecimen procurement and coordination. Demonstrated ability to operate at a high degree of independence. Demonstrated ability to coordinate studies of high complexity. Experience coordinating research; including obtaining informed consent and enrolling subjects into protocols.
Work Schedule
Monday - Friday, 8:30AM - 5:30PM