Clinical research associate jobs in High Point, 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.

Department: 38923 Wake Forest University Health Sciences - Gerontology Status: Part time Benefits Eligible: Yes Hours Per Week: 20 Schedule Details/Additional Information: Part-time 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.

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 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.

Back to Search Results Clinical Studies Coordinator I, Internal Medicine Winston Salem, NC, United States Shift: 1st Job Type: Regular Share: mail

The Licensed Practitioner is responsible for : Conducting Assessments of consumers Conducting Outpatient therapy Conducting Intakes Submitting clients for Reauthorization Conducting Group sessions Complete updates as neccessary for client's file Working with both populations Adults and Adolescence Provide screening and therapeutic consuling to consumers Assisting in other areas that is required by the agency Qualifications Licensed Clinical Practitioner must have Masters Degree in Human Services field with at least one year documented experience in mental health and/or substance abuse. Licensed Practitioner must maintain valid CPR, TB Skin Test, Medication Management, BBP, NCI or training on Alternative to Restictive Intervention. Licensed Practitioner must maintain trainings required by board. Additional Information All your information will be kept confidential according to EEO guidelines.

As part of the Samuel Research Team (PI: Dr. Raymond E Samuel, Professor of Biology), the Program Coordinator provides day-today administration for research, education, training, and outreach activities. The Program Coordinator applies his/her organizational skills and expertise to reduce the administrative burden on researchers. The Program Coordinator works with Division of Research and Business Office staff to manage complex budgets and ensure that funding agency requirements are met throughout the grant award life cycle. The Program Coordinator works closely with the PIs while also prioritizing and completing multiple tasks and deadlines with limited support. The Program Coordinator works independently in a team-supported environment and reports to Samuel Research Team leader, in addition to working closely with a small number of faculty. Extensive interactions are required with researchers, the NC A&T administration offices, and external institutions. Detailed job duties include: * Coordinate and manage project administrative operations such as hiring, subawards, contracts, and fiscal management in partnership with other internal units. * Monitor budgets and resources to meet research project objectives, ensure compliance, and anticipate future project needs. Prepare regular reports and spending plans as needed. * Research internal and external policies and procedures when questions arise. * Recommend and develop team collaboration and communication processes and tools, adapting to the work style and needs of PIs and project teams. Share ideas based on best practices and lessons learned. * Other activities as needed on behalf of project PIs or the Samuel Research Team. Primary Function of Organizational Unit North Carolina Agricultural and Technical State University is an 1890 land-grant doctoral research university dedicated to learning, discovery, and community engagement. The University provides a wide range of educational opportunities from bachelor's to doctoral degrees in both traditional and online environments. With an emphasis on preeminence in STEM and a commitment to excellence in all its educational, research, and outreach programs, North Carolina A&T fosters a climate of economic competitiveness that prepares students for the global society. Work Hours 8-5 pm Monday - Friday Is this position eligible for a remote or hybrid work arrangement, consistent with university and state policies. Key Responsibilities and Related Competencies

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

CRC Level 1 - Winston Salem, NC (Onsite) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We have an incredible opportunity for a Clinical Research Coordinator 1 to join ICON's Accellacare team. The CRC ensures the safety of our volunteers, promotes the mission of Accellacare, and strives to meet and exceed study priorities. This individual is responsible for recruiting and promoting our service to suitable participants and sponsor representatives. Additionally, the CRC will perform tasks required to coordinate and complete a study according to the protocol. This role is with Accellacare (********************************** , part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research. **Location:** Onsite (1901 S. Hawthorne Road, Suite 306, Winston-Salem, NC) **What you will be doing:** + Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator. + Attending investigator meetings, site initiation visits, and coordinator meetings to obtain training on drug preparation and administration and general knowledge about a protocol with a focus on clinical procedures. + Obtaining knowledge about the study drugs with an emphasis on injection or intravenous infusion medications. + Monitoring for possible complications with the administration of study drugs with an emphasis on injections or intravenous infusions. + Maintaining accurate dispensing logs, separate from those of the coordinator, to include such information as lot number, drug vs. placebo, and information about the third party mixer or un-blinded mixer/preparer of medication. + Documenting laboratory data and adverse reactions, and immediately notifying investigators, sponsors and the Institutional Review Board, if indicated, of any unexpected or serious events. + Assisting other staff members as determined by the needs and priorities of the research organization and as time and abilities permit. + Actively recruiting and effectively selling our service to suitable patient participants for clinical trials with set time allotted each week for recruitment efforts. + Proactively promoting the site with monitors and in-house contacts for future trials. + Responding to queries in a timely manner, prompt data entry and working with the monitor during on-site visits are examples of pro-active behaviors. + Preparing study documentation in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit. + Ordering clinical supplies, as well as ordering, storing and monitoring of protocol specific rescue drugs and maintaining scheduled assessment of the code/crash cart and AED including maintaining proper documentation for both. + Monitoring and maintaining refrigerators, freezer units and investigational product storage temperatures for safety and stability. + Obtaining and maintaining knowledge in regards to temperature monitoring devices and procedures for lab specimens and investigational products and providing detailed information to all staff and sponsors in regards to how temperatures are monitored and maintained. + Maintaining certification for packaging and shipping specimens on dry ice, as well as maintaining and updating knowledge of lab procedures to assist with work flow. + Acting as the OSHA Representative for the site which would include but not be limited to; maintaining employee immunization records, obtaining vaccines when necessary for site or PMG and administering vaccines to staff. + Performing equipment calibration when needed, if not performed by the lab coordinator or outside service and maintaining equipment calibration records. + Supporting training and additional development of clinical skills for site staff as needed **Your Profile:** + 1+ years of work experience in a clinical research or pharmaceutical environment, with prior CRC experience + Experience with Neurology or Psychiatric clinical trials + Strong attention to detail + Motivated about a career in clinical research + Excellent time management and planning skills with an organized approach to work + Bachelor's degree in life sciences or other related field \#LI-Office \#LI-SB4 \#LI-Accellacare **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply

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

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

CRC Level 1 - Winston Salem, NC (Onsite) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We have an incredible opportunity for a Clinical Research Coordinator 1 to join ICON's Accellacare team. The CRC ensures the safety of our volunteers, promotes the mission of Accellacare, and strives to meet and exceed study priorities. This individual is responsible for recruiting and promoting our service to suitable participants and sponsor representatives. Additionally, the CRC will perform tasks required to coordinate and complete a study according to the protocol. This role is with Accellacare, part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research. Location: Onsite (1901 S. Hawthorne Road, Suite 306, Winston-Salem, NC) What you will be doing: * Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator. * Attending investigator meetings, site initiation visits, and coordinator meetings to obtain training on drug preparation and administration and general knowledge about a protocol with a focus on clinical procedures. * Obtaining knowledge about the study drugs with an emphasis on injection or intravenous infusion medications. * Monitoring for possible complications with the administration of study drugs with an emphasis on injections or intravenous infusions. * Maintaining accurate dispensing logs, separate from those of the coordinator, to include such information as lot number, drug vs. placebo, and information about the third party mixer or un-blinded mixer/preparer of medication. * Documenting laboratory data and adverse reactions, and immediately notifying investigators, sponsors and the Institutional Review Board, if indicated, of any unexpected or serious events. * Assisting other staff members as determined by the needs and priorities of the research organization and as time and abilities permit. * Actively recruiting and effectively selling our service to suitable patient participants for clinical trials with set time allotted each week for recruitment efforts. * Proactively promoting the site with monitors and in-house contacts for future trials. * Responding to queries in a timely manner, prompt data entry and working with the monitor during on-site visits are examples of pro-active behaviors. * Preparing study documentation in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit. * Ordering clinical supplies, as well as ordering, storing and monitoring of protocol specific rescue drugs and maintaining scheduled assessment of the code/crash cart and AED including maintaining proper documentation for both. * Monitoring and maintaining refrigerators, freezer units and investigational product storage temperatures for safety and stability. * Obtaining and maintaining knowledge in regards to temperature monitoring devices and procedures for lab specimens and investigational products and providing detailed information to all staff and sponsors in regards to how temperatures are monitored and maintained. * Maintaining certification for packaging and shipping specimens on dry ice, as well as maintaining and updating knowledge of lab procedures to assist with work flow. * Acting as the OSHA Representative for the site which would include but not be limited to; maintaining employee immunization records, obtaining vaccines when necessary for site or PMG and administering vaccines to staff. * Performing equipment calibration when needed, if not performed by the lab coordinator or outside service and maintaining equipment calibration records. * Supporting training and additional development of clinical skills for site staff as needed Your Profile: * 1+ years of work experience in a clinical research or pharmaceutical environment, with prior CRC experience * Experience with Neurology or Psychiatric clinical trials * Strong attention to detail * Motivated about a career in clinical research * Excellent time management and planning skills with an organized approach to work * Bachelor's degree in life sciences or other related field #LI-Office #LI-SB4 #LI-Accellacare What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

'The Clinical Research Coordinator works closely with study subjects and other research staff and is responsible for the day-to-day clinical research process to collect, compile, document, and analyze clinical research data. Working under direct supervision, the position assists the investigator with subject follow-up visits, completes clinical tasks, prepares research documentation, reports, and graphs while keeping appropriate logs, tracking participants, and preparing study materials. Assesses patients for protocol eligibility, ensuring the appropriate selection of participants for clinical trials, thereby enhancing the accuracy and validity of research outcomes. Confers with study participants to explain the purpose of the study and obtains informed consent, fostering transparency and trust with patients and their families throughout the research process. Collects data from various sources, including patient charts, medical records, interviews, and diagnostic tests, and prepares comprehensive documentation, ensuring the accurate and reliable analysis of research data. When applicable, completes documentation in the electronic health/medical record (EMR) system to securely maintain patient health records. Coordinates multiple, less complex clinical trials simultaneously, managing and organizing various research activities efficiently, and ensuring optimal use of resources and timely execution of research protocols. Serves as study coordinator for pharmaceutical and/or device trials, successfully coordinating site initiation visits, monitoring visits, and close-out visits, and ensuring adherence to protocol guidelines and regulatory requirements. Supports the regulatory process in the submission of study protocols, consent forms, and recruiting materials to the Institutional Review Board and the department for approval, facilitating the regulatory compliance necessary for research projects in the hospital. Completes clinical tasks (i.e., electrocardiogram (ECG), pulmonary function tests (PFT), phlebotomy, drug administration, etc.) when not prohibited by state or licensing board requirements under the supervision of the principal investigator. Performs other duties as assigned. EDUCATION:Required: Bachelor's degree OR Associate's Degree (with 2 yrs experience) OR Healthcare/Health-related certification, e.g., EMT, Pharm Tech, Rad Tech, etc. (with 4 yrs experience) EXPERIENCE:Required: 4 Years (education and/or experience) LICENSURE/CERTIFICATION/REGISTRY/LISTING:Preferred: Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification Equal Opportunity Employer At Cone Health, we strive to create a welcoming atmosphere that celebrates a diverse and unique workforce. We believe in offering equal opportunities for employment to all applicants and employees, regardless of their race, religion, age, sex, sexual orientation, gender identity, veteran's status, ethnicity, national origin, disability, color, or any other characteristic protected by law. Our hiring and employment choices are based on each individual's qualifications, skills and performance. We believe that by embracing the diversity of our team, we can better serve our patients, communities and each other.

Department: 37371 Wake Forest University Health Sciences - Comprehensive Cancer Center Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: 40 hours per week M-F. No weekends. No holidays. 2 remote days allowed upon completion of 90-day orientation. Pay Range $23.65 - $35.50 Job Summary Under thedirection of the Study Investigators and Disease Group Chair, mentorship of experienced clinical studies coordinator staff, supervision of the Nurse Team Leader and the leadership of the Director of Clinical Protocol and Data Management, the Clinical Studies Coordinator I coordinates activities to support research studies. Able to manage low complexity trials after completion of orientation. Assignments are gradually adjusted to add increased responsibility based on demonstrated competency. Mentored by an experienced clinical research coordinator II or III, serves as the principle administrative liaison for assigned studies. Follows 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 in a related field of study or an equivalent combination of experience and education. Experience in a medical and/or research setting. Paramedical experience or other clinical experience. 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 Study Conduct * Works under the supervision of the Study Investigators, Disease Group Chair and the direction of the Administrative Director of Clinical Protocol and Data Management. * Works in conjunction with a clinical studies coordinator mentor and the oversight of a Nurse Team Leader to gradually assume more responsibility and workload * Assists in the recruitment of patients to study by helping to identify potential eligible patients who are scheduled to be seen in the clinic and communicating the information to the Study Team. * Performs protocol specific duties required per the research protocol, including but not limited to: * Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families. * Confirms and documents subject eligibility. * As part of the team, ensures all protocol procedures are ordered and completed as specified in the protocol. * Randomizes subjects using interactive voice response systems or other systems as applicable. * Administers standardized tools or questionnaires, such as Quality of Life assessments, if appropriately credentialed. * Assembles lab kits and other supplies in preparation to obtain required biospecimen samples and transports to appropriate laboratories for processing; ships samples externally per International Air Transport Association (IATA) requirements. * Optimizes the safety of research subjects by monitoring and reporting any adverse events to the investigators and other members of the study team. * Participates in required teleconferences, on site meetings and off site investigator meetings, as required. Regulatory Compliance and Documentation. * Fulfills sponsor requirements related to reportable information, including: adverse events, unanticipated problems, other information required by the sponsor protocol. Data Management * 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. * Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner. Personnel Management * 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. 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. Performs other related duties as assigned or requested. Skills and Qualifications Knowledge of medical terminology. Exposure to clinical trials or related health field is preferred. Excellent oral/written communication and organizational skills. Excellent reading comprehension. Foster/promote a positive image and professional appearance. Sensitivity to intercultural relations. Sensitivity to the maintenance of confidentiality. Ability to use Microsoft products, access data in computer data bases, compile data, and research information. Proofread documents. Troubleshoot problems. 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.

Back to Search Results Clinical Studies Coordinator I, Pulmonology Winston Salem, NC, United States Shift: Various Job Type: Regular Share: mail

The Clinical Research Coordinator II works closely with study subjects and other research staff and is responsible for the day-to-day clinical research process to collect, compile, document, and analyze clinical research data. Working under general supervision, the position conducts subject follow-up visits, completes clinical tasks, prepares research documentation, reports, and graphs while keeping appropriate logs, tracking participants, and preparing study materials. Responsibilities Coordinates multiple clinical trials simultaneously or clinical trials with unique complexity, managing and organizing various research activities efficiently, ensuring optimal use of resources and timely execution of research protocols. Assesses patients for protocol eligibility, ensuring the appropriate selection of participants for clinical trials, thereby enhancing the accuracy and validity of research outcomes. Confers with study participants to explain the purpose of the study and obtains informed consent, fostering transparency and trust with patients and their families throughout the research process. Collects data from various sources, including patient charts, medical records, interviews, and diagnostic tests, and prepares comprehensive documentation, ensuring the accurate and reliable analysis of research data. When applicable, completes documentation in the electronic health/medical record (EMR) system to securely maintain patient health records. Completes clinical tasks (i.e., ECGs, PFTs, phlebotomy, drug administration, etc.) when not prohibited by state or licensing board requirements under the supervision of the principal investigator. Serves as study coordinator for pharmaceutical and/or device trials, successfully coordinating site initiation visits, monitoring visits, and close-out visits, and ensuring adherence to protocol guidelines and regulatory requirements. Supports the regulatory process in the submission of study protocols, consent forms, and recruiting materials to the Institutional Review Board and the department for approval, facilitating the regulatory compliance necessary for research projects in the hospital/medical group setting. Mentors and trains Clinical Research Coordinators and Clinical Research Specialists to ensure an effective and compliant team. Performs other duties as assigned. Qualifications EDUCATION: Required: Associate degree with 4 years of Clinical Research experience OR Bachelor's degree with 2 years of clinical research experience EXPERIENCE: Required: 6 years (education and/or experience) LICENSURE/CERTIFICATION/REGISTRY/LISTING: Required: Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification

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 This role is with Accellacare , part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research. Title: CRC Level I (Clinical Research Coordinator) Location: On-Site (Salisbury, NC) Summary: The CRC ensures the safety of our volunteers, promotes the mission of Accellacare, and strives to meet and exceed study priorities. This individual is responsible for recruiting and promoting our service to suitable participants and sponsor representatives. Additionally, the CRC will perform tasks required to coordinate and complete a study according to the protocol. Duties: Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator. Attending investigator meetings, site initiation visits, and coordinator meetings to obtain training on drug preparation and administration and general knowledge about a protocol with a focus on clinical procedures. Obtaining knowledge about the study drugs with an emphasis on injection or intravenous infusion medications. Monitoring for possible complications with the administration of study drugs with an emphasis on injections or intravenous infusions. Maintaining accurate dispensing logs, separate from those of the coordinator, to include such information as lot number, drug vs. placebo, and information about the third party mixer or un-blinded mixer/preparer of medication. Documenting laboratory data and adverse reactions, and immediately notifying investigators, sponsors and the Institutional Review Board, if indicated, of any unexpected or serious events. Assisting other staff members as determined by the needs and priorities of the research organization and as time and abilities permit. Actively recruiting and effectively selling our service to suitable patient participants for clinical trials with set time allotted each week for recruitment efforts. Proactively promoting the site with monitors and in-house contacts for future trials. Responding to queries in a timely manner, prompt data entry and working with the monitor during on-site visits are examples of pro-active behaviors. Preparing study documentation in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit. Ordering clinical supplies, as well as ordering, storing and monitoring of protocol specific rescue drugs and maintaining scheduled assessment of the code/crash cart and AED including maintaining proper documentation for both. Monitoring and maintaining refrigerators, freezer units and investigational product storage temperatures for safety and stability. Obtaining and maintaining knowledge in regards to temperature monitoring devices and procedures for lab specimens and investigational products and providing detailed information to all staff and sponsors in regards to how temperatures are monitored and maintained. Maintaining certification for packaging and shipping specimens on dry ice, as well as maintaining and updating knowledge of lab procedures to assist with work flow. Acting as the OSHA Representative for the site which would include but not be limited to; maintaining employee immunization records, obtaining vaccines when necessary for site or PMG and administering vaccines to staff. Performing equipment calibration when needed, if not performed by the lab coordinator or outside service and maintaining equipment calibration records. Supporting training and additional development of clinical skills for site staff as needed To be successful, you will have: Bachelor's life science degree, or relevant industry-field experience 1 years' work experience in clinical research or pharmaceutical environment would be desirable High level of attention to detail Personable, able to build rapport with patients with ease Motivated about a career in clinical research Excellent planner, organized approach to work #LI-onsite #LI-SB4 #LI-Accellacare What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, 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

Department: 36962 Wake Forest University Health Sciences - Cardiology: Adult Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: Varies Pay Range $23.65 - $35.50 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. Experience in a medical and/or research setting. Paramedical experience or other clinical experience. LICENSURE, CERTIFICATION, and/or REGISTRATION Registered Record Administrator preferred SKILLS/QUALIFICATIONS * Understanding of medical and/or scientific terminology * Strong oral, written, and interpersonal communication skills ESSENTIAL FUNCTIONS * 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. * Performs technical procedures on clinical subjects under the direction of the principal investigator or his/her designee. * 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. * Maintains appropriate patient records as necessary. This includes charting the condition of the patient and determining their continued eligibility in the study. * Obtains and interprets pertinent data from medical records as needed to understand past and present condition of the patients. * Performs day-to-day administrative and clerical duties such as designing brochures, stationery and data forms. Creates reports and graphs pertinent to the study including presentation of the results of the study. * May supervise other personnel including volunteers as assigned. * Assists in development of suitable codes and data collection forms for computerization. * Consults and cooperates with all faculty, coordination centers, sponsors, and health professionals involved in the clinical study. * Performs other related duties incidental to the work described herein. WORK ENVIRONMENT Clean, well-lit, office environment and community settings 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.

Back to Search Results Clinical Studies Coordinator II, Cardiology Research Winston Salem, NC, United States Shift: 1st Job Type: Regular Share: mail

'The Clinical Research Coordinator works closely with study subjects and other research staff and is responsible for the day-to-day clinical research process to collect, compile, document, and analyze clinical research data. Working under direct supervision, the position assists the investigator with subject follow-up visits, completes clinical tasks, prepares research documentation, reports, and graphs while keeping appropriate logs, tracking participants, and preparing study materials. Responsibilities Assesses patients for protocol eligibility, ensuring the appropriate selection of participants for clinical trials, thereby enhancing the accuracy and validity of research outcomes. Confers with study participants to explain the purpose of the study and obtains informed consent, fostering transparency and trust with patients and their families throughout the research process. Collects data from various sources, including patient charts, medical records, interviews, and diagnostic tests, and prepares comprehensive documentation, ensuring the accurate and reliable analysis of research data. When applicable, completes documentation in the electronic health/medical record (EMR) system to securely maintain patient health records. Coordinates multiple, less complex clinical trials simultaneously, managing and organizing various research activities efficiently, and ensuring optimal use of resources and timely execution of research protocols. Serves as study coordinator for pharmaceutical and/or device trials, successfully coordinating site initiation visits, monitoring visits, and close-out visits, and ensuring adherence to protocol guidelines and regulatory requirements. Supports the regulatory process in the submission of study protocols, consent forms, and recruiting materials to the Institutional Review Board and the department for approval, facilitating the regulatory compliance necessary for research projects in the hospital. Completes clinical tasks (i.e., electrocardiogram (ECG), pulmonary function tests (PFT), phlebotomy, drug administration, etc.) when not prohibited by state or licensing board requirements under the supervision of the principal investigator. Performs other duties as assigned. Qualifications EDUCATION: Required: Bachelor's degree OR Associate's Degree (with 2 yrs experience) OR Healthcare/Health-related certification, e.g., EMT, Pharm Tech, Rad Tech, etc. (with 4 yrs experience) EXPERIENCE: Required: 4 Years (education and/or experience) LICENSURE/CERTIFICATION/REGISTRY/LISTING: Preferred: Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification