Clinical Research Coordinator III
Clinical research coordinator job in Stone Mountain, GA
Denali Health is a fast-growing clinical research organization dedicated to improving patient outcomes through innovative, high-quality clinical trials. We partner with leading physicians and sponsors to accelerate breakthrough treatments and foster greater access to research opportunities across diverse communities.
Position Summary
The Clinical Research Coordinator III (CRC III) is responsible for leading the coordination and execution of complex clinical research studies, ensuring compliance with study protocols, regulatory requirements, and institutional guidelines. The ideal candidate is a proactive professional with strong organizational and leadership skills, capable of managing multiple studies and mentoring junior coordinators.
Key Responsibilities
Coordination of Clinical Trials:
Oversee all aspects of assigned clinical studies, including start-up, recruitment, informed consent, data collection, and study close-out. Serve as the primary liaison between investigators, sponsors, CROs, and regulatory agencies.
Study Management:
Ensure that study activities are conducted in accordance with GCP, IRB guidelines, and sponsor requirements. Maintain accurate and up-to-date source documentation and regulatory binders.
Participant Coordination:
Schedule and coordinate participant visits, assessments, and follow-ups while maintaining excellent communication and care for study participants.
Regulatory and Compliance Oversight:
Prepare and submit IRB documents, safety reports, and study updates. Ensure audit readiness at all times.
Data Management:
Enter, review, and verify data in EDC systems and ensure timely query resolution.
Team Coordination & Leadership:
Mentor and support CRC I and II staff, ensuring consistent application of best practices and promoting a culture of quality and accountability.
Communication & Reporting:
Coordinate communication among multidisciplinary teams to ensure efficient trial operations and timely reporting of progress and outcomes.
Qualifications
Bachelor's degree in health sciences, nursing, or a related field (advanced degree preferred).
Minimum 3-5 years of experience in clinical research coordination.
Strong understanding of GCP, ICH, and FDA regulations.
Exceptional coordination, multitasking, and communication skills.
Experience with EDC systems and clinical trial management software preferred.
CCRC/CCRP certification a plus.
Why Join Denali Health
Work with a mission-driven team advancing clinical research accessibility.
Competitive salary and comprehensive benefits package.
Professional growth and leadership opportunities.
Collaborative environment focused on innovation and patient care.
To Apply:
Please send your resume, video recording as to why you feel you would be a good fit for this role, and cover letter to ********************
with the subject line
“Clinical Research Coordinator III - Stone Mountain.”
Neuroscience Research Coordinator
Clinical research coordinator job in Kennesaw, GA
About Us Are you ready to transform lives through academic excellence, innovative research, strong community partnerships and economic opportunity? Kennesaw State University is one of the 50 largest public institutions in the country. With growing enrollment and global reach, we continue to expand our institutional influence and prominence beyond the state of Georgia. We offer more than 190 undergraduate, graduate, and doctoral degrees to empower our 47,000 students to become thought leaders, lifelong learners, and informed global citizens. Our entrepreneurial spirit, high-impact research, and Division I athletics draw students from throughout the region and from more than 100 countries across the globe. Our university's vibrant culture, career opportunities, rich benefits, and values of respect, integrity, collaboration, inclusivity, and accountability make us an employer of choice. We are part of the University System of Georgia. We are searching for talented people to join Kennesaw State University in our vision. Come Take Flight at KSU!
Location
(Primary Location for Job Responsibilities) Our Kennesaw campus is located at 1000 Chastain Road NW, Kennesaw, GA 30144.
Job Summary
Performs activities supporting assigned, externally funded research programs (e.g., student supervision, experiment design and execution, data collection and interpretation, manuscript, and grant proposal development). Operates and manages equipment for research faculty and staff. Responsible for the oversight of operations and maintenance of assigned research laboratories (e.g., plans, organizes, and coordinates operation of the research space; interacts closely with research faculty and staff to provide training, consultation, and other services as offered by the research facility or research space).
This position is contingent on the research funding availability which is currently only secured through December 31st, 2026.
Responsibilities
KEY RESPONSIBILITIES:
1. Performs research activities supporting an externally funded research program
2. Supervises the operations of the research laboratory
3. Provides training to undergraduate and graduate students performing research, and to researchers (faculty and staff) on instrument operation
4. Independently conducts research experiments
5. Contributes to experiment design and implementation, data collection and interpretation
6. Uses standard evaluation tools and methods and assists in the creation of new Data collection instruments when necessary
7. Supports grant writing and proposal development
8. Directs the operations of a science research facility, equipment, or research space, ss needed
9. Develops policies and procedures for scientific research facilities
10.Manages equipment for the scientific research facility
11. Provides assistance on experiment design, data analysis, and interpretation as appropriate
12. Ensures the scientific research facility is compliant with regulatory agencies and KSU s policies and procedures
13. Provides the appropriate documentation to support prices for services
14. Accurately compiles information for monthly billing
15. Consults with users to determine their satisfaction with services provided by the Scientific research facility
Required Qualifications
Educational requirements
Bachelor's degree from an accredited institution of higher education in a field related to position.
Required Experience
Prior research in a related field
Supervisory experience
Experience running research facility instrumentation
Preferred Qualifications
Additional preferred qualifications
Previous experience within the area of study.
Proposed Salary
The midpoint of the salary range is $44,150. Offers are based on relevant experience. Comprehensive benefits to include Medical, Dental, Vision, 13 paid holidays, vacation, generous retirement plans, tuition waiver, wellness options, and much more! Visit hr.kennesaw.edu/benefits
Knowledge, Skills, & Abilities
Abilities
Ability to lead and conduct research
Ability to train undergraduate and graduate students
Ability to manage research facility
Able to handle multiple tasks or projects at one time meeting assigned deadlines
Skills
Excellent interpersonal, initiative, teamwork, problem solving, independent judgment, organization, communication (verbal and written), time management, project management and presentation skills
Proficient in the operation of facility instrumentation
Proficient with computer applications and programs associated with the position (i.e.,
Microsoft Office suite)
Strong attention to detail and follow up skills
Strong customer service skills and phone and e-mail etiquette
USG Core Values
The University System of Georgia is comprised of our 26 institutions of higher education and learning as well as the System Office. Our USG Statement of Core Values are Integrity, Excellence, Accountability, and Respect. These values serve as the foundation for all that we do as an organization, and each USG community member is responsible for demonstrating and upholding these standards. More details on the USG Statement of Core Values and Code of Conduct are available in USG Board Policy 8.2.18.1.2 and can be found on-line at **************************************************************************
Additionally, USG supports Freedom of Expression as stated in Board Policy 6.5 Freedom of Expression and Academic Freedom found on-line at ************************************************
Equal Employment Opportunity
Kennesaw State University is an Equal Employment Opportunity Employer. The University is committed to maintaining a fair and respectful environment for living, work and study. To that end, and in accordance with federal and state law, Board of Regents policy, and University policy, the University prohibits harassment of or discrimination against any person because of race, color, sex (including sexual harassment, pregnancy, and medical conditions related to pregnancy), sexual orientation, gender identity, gender expression, ethnicity or national origin, religion, age, genetic information, disability, or veteran or military status by any member of the KSU Community on campus, in connection with a University program or activity, or in a manner that creates a hostile environment for members of the KSU community.
For additional information on this policy, or to file a complaint under the provisions of this policy, students, employees, applicants for employment or admission or other third parties should contact the Office of Institutional Equity at English Building, Suite 225, ****************.
Other Information
This is not a supervisory position.
This position does not have any financial responsibilities.
This position will not be required to drive.
This role is not considered a position of trust.
This position does not require a purchasing card (P-Card).
This position may travel 1% - 24% of the time
Background Check
* Standard Enhanced
* Education
Per the University System of Georgia background check policy, all final candidates will be required to consent to a criminal background investigation. Final candidates may be asked to disclose criminal record history during the initial screening process and prior to a conditional offer of employment. Applicants for positions of trust with screening
results which confirm a disqualifying criminal history will be immediately disqualified from employment eligibility.
All applicants are required to include professional references as part of their application process. Some positions may require additional job-based screenings such as motor vehicle report, credit check, pre-employment drug screening and/or verification of academic credentials.
*****************************************************************************************
Easy ApplyClinical Research Specialist (PRN/Physical Therapist) - Program in Physical Therapy
Clinical research coordinator job in Forest Park, GA
This is a zero-hourly position (PRN) and individual will work on an as-needed basis. Flexibility is essential due to the needs of the research participants and lab. Position provides skilled, thorough, physical therapy assessments for research participants with musculoskeletal pain conditions. Responsibilities include participant recruitment, screening, scheduling, measurement, data processing and analysis support. Works with Principal Investigator (PI) to execute responsibilities within a team framework of exchange and open communication in a clinically-oriented research laboratory.Job Description
Primary Duties & Responsibilities:
Communicates effectively with multiple personnel across a variety of recruitment sites to ensure timely participant recruitment.
Performs participant screening, scheduling for laboratory and treatment visits, and regular follow-up communication to maintain participant retention.
Provides clinical assessments of research participants according to study protocols, which may include assessments of pain, neurological function, strength, motor control, sensation, functional activities (e.g., walking), functional limitations, disability, quality of life and other areas.
Operates equipment to measure movement including research-grade movement sensors and other equipment as needed for data collection.
Works with PI, Clinical Research Coordinator and Clinical Research Assistants to ensure proper creation, processing and maintenance of data files in a database and proper coding/storage of data to comply with HIPAA and WUSM HRPO regulations.
Assist with processing and basic analyses of data according to study protocols and as discussed with the PI and the research team.
Competently uses a variety of software for successful participant recruitment and retention, data collection, processing, and analysis.
Develops and implements documentation records and procedures including methods for managing data collection.
Works effectively and efficiently with a team that includes the PI, Clinical Research Coordinator, Clinical Research Assistants, graduate students and others on interdisciplinary research projects.
Acts as a resource to community therapists and to participants seeking therapeutic resources within the community.
Follows up laboratory visits with phone calls to participants and participants' families when required.
Working Conditions:
Job Location/Working Conditions
Normal lab/office environment
Patient care setting
Requires protective devices
Physical Effort
Occasional lifting 25-50 lbs.
Frequent lifting 25lbs. or more
Ability to lift ten pounds from floor to waist, carry ten pounds for short distances
Push and pull occasionally with moderate force
Ability to coordinate hand movements to write, type, manipulate folders, and client body parts
Equipment
Therapy equipment
Lab equipment
Office equipment
Clinical/diagnostic equipment
The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.Required Qualifications
Education:
Bachelor's degree
Certifications:
The list below may include all acceptable certifications and issuers. More than one credential or certification may be required depending on the role.Basic Life Support - American Heart Association, Basic Life Support - American Red Cross, Occupational Therapist - Illinois Department of Financial and Professional Regulation, Occupational Therapist - Missouri Division of Professional Registration, Physical Therapist - Illinois Department of Financial and Professional Regulation, Physical Therapist - Missouri Division of Professional Registration
Work Experience:
Clinical Or Research (5 Years)
Skills:
Not Applicable
Driver's License:
A driver's license is not required for this position.More About This Job
Required Qualifications:
Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements).
Currently licensed or eligible for licensure in the state of Missouri as a Physical Therapist.
Preferred Qualifications
Education:
No additional education beyond what is stated in the Required Qualifications section.
Certifications:
No additional certification beyond what is stated in the Required Qualifications section.
Work Experience:
No additional work experience beyond what is stated in the Required Qualifications section.
Skills:
Adaptability, Compliance Requirements, Computer Literacy, Confidentiality, Critical Thinking, Customer Service, Data Collection Methods, Detail-Oriented, High Accuracy, Human Subjects Research, Interpersonal Communication, Laboratory Research, Multitasking, Organizing, Orthopaedic Physical Therapy, Patient Counseling, Patient Screening, Prioritization, Professional Etiquette, Research Databases, Research Recruitment, Scheduling, Scientific Reasoning, Teamwork, Working IndependentlyGradeR12-H
Salary Range
$32.53 - $55.29 / HourlyThe salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.Questions
For frequently asked questions about the application process, please refer to our External Applicant FAQ.
Accommodation
If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request.
All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.Pre-Employment ScreeningAll external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.Benefits StatementPlease visit our website at ****************************** to review our benefit eligibility criteria along with any applicable benefits.EEO StatementWashington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.
Auto-ApplyResearch Coordinator - Solid Tumor
Clinical research coordinator job in Atlanta, GA
Note: If you are CURRENTLY employed at Children's and/or have an active badge or network access, STOP here. Submit your application via Workday using the Career App (Find Jobs). Work Shift Day Work Day(s) Monday-Friday Shift Start Time 8:00 AM Shift End Time
4:30 PM
Worker Sub-Type
Regular
Children's is one of the nation's leading children's hospitals. No matter the role, every member of our team is an essential part of our mission to make kids better today and healthier tomorrow. We're committed to putting you first, and that commitment is at the heart of our company culture: People first. Children always. Find your next career opportunity and make a difference doing what you love at Children's.
Job Description
Develops, implements, and supports the research process by assisting investigators in study design, completion of the approval process, and management of data specific to the subspecialty of involvement. Proactively supports the efforts that ensure delivery of safe patient care and services and promotes a safe environment at Children's Healthcare of Atlanta.
Experience
* One year of research experience. May substitute required experience with equivalent years of education beyond the minimum education requirement
Preferred Qualifications
* Bachelor's degree in Health or Biological Sciences
Education
* Bachelor's degree in a scientific, health related, or business administration related program or relevant experience in lieu of education
Certification Summary
* Basic Life Support (BLS) within 30 days of employment if role requires patient contact
* ARUP Handling, Packaging and Shipping Infectious Substances or similar within 30 days of employment if role requires specimen acquisition
* Collaborative Institutional Training Initiative (CITI) within 30 days of employment
Knowledge, Skills, and Abilities
* Working knowledge of state and federal regulatory guidelines related to research
* Good computer skills including working knowledge of a PC and Microsoft Office (Word, Access, and Excel)
* Self-directed and motivated to work independently toward short- and long-term goals
* Good communication, organization, and interpersonal skills
* Good working relationships with colleagues, subordinates, and superiors
Job Responsibilities
Develops, conducts, and facilitates research protocols.
* Supports investigators in writing study protocols.
* Performs participant screening, enrollment, study activities, and communication.
* Coordinates study visits and procedures, including specimen acquisition, transport, documentation, and shipment.
* Maintains equipment and supply resources for research studies.
* Completes data management activities and ensures data integrity.
* Assists in the development and completion of source documents and case report forms.
* Participates in sponsor correspondence, monitoring, and study meetings.
* Monitors compliance throughout all study activities and engages compliance oversight as needed.
* Directs patient interaction to conduct research protocols.
* Obtains informed consent by following policy, procedure, and regulatory requirements.
* Schedules study-specific visits in conjunction with ancillary departments.
* Administers various research surveys in accordance with research study requirements.
* Completes research-only testing as required and applicable per study and system requirements, including electrocardiograms.
* Performs phlebotomy if trained to do so.
* Provides research study education to participants as part of a study protocol.
* Completes documentation as needed within the medical record.
Manages all regulatory processes related to clinical research activities.
* Completes Institutional Review Board preparation, submission, modifications, reporting, and termination activities.
* Maintains all licensure, certification, and system education requirements for role.
* Maintains all regulatory documents.
* Assist with facilitating grants, contracts, and financial tasks for research and clinical trials.
* Assist with supporting Principal Investigator in study budgeting, sponsor interactions, routing, feasibility assessments, account management, and reconciliation.
* Completes research administrative duties according to Children's policies regarding Epic enrollment, Clinical Trial Management System data entry, patient care invoice accuracy.
Participates in education activities to support specific research activities and primary role at Children's Healthcare of Atlanta.
* May participate in departmental policy and quality projects.
* Completes departmental, system-wide, and study-specific education as required.
Children's Healthcare of Atlanta is an equal opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, sex, religion, national origin, citizenship, age, veteran status, disability or any other characteristic covered by applicable law.
Primary Location Address
1575 Northeast Expy NE
Job Family
Research
Clinical Research Associate 1
Clinical research coordinator job in Atlanta, GA
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1 -2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi -task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self -motivated, assertive, and driven
BenefitsDental, Medical, Vision, PTO and 401K
Clinical Research Associate II - Transplant and Transfusion
Clinical research coordinator job in Norcross, GA
A Clinical Research Associate II (CRA-II) plays a key role in monitoring and ensuring the integrity of clinical studies that evaluate the safety, performance, and effectiveness of medical devices and related products. This position supports the clinical operations function by ensuring compliance with applicable regulatory requirements and study protocols. By safeguarding data quality and patient safety, the CRA-II enables the organization to bring innovative healthcare solutions to market efficiently and ethically. The role adds value by bridging scientific research with operational excellence, ensuring studies are executed on time and to the highest quality standards
Responsibilities
Key Accountabilities
Conduct site qualification, initiation, monitoring, and close-out visits to ensure compliance with study protocols and regulatory requirements.
Serve as the primary point of contact between the sponsor and investigator sites, fostering effective communication and issue resolution.
Verify that investigator sites have adequate resources, qualified staff, and investigational products throughout the study lifecycle.
Ensure adherence to Good Clinical Practice (GCP), company SOPs, and applicable regulatory guidelines for all assigned studies.
Monitor data integrity by reviewing source documents, case report forms, and ensuring accurate and complete trial records.
Identify, document, and communicate protocol deviations, non-compliance, and safety issues promptly.
Assist in managing study timelines, budgets, and deliverables, escalating risks.
Prepare and maintain essential clinical trial documentation, including protocols, agreements, study reports, and site communications.
Assist with reagent inventory management - ordering, storage and dispostion of investigation products and study supplies
Uses the English language effectively in both written and verbal communication to convey complex clinical concepts with clarity and precision.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Networking/Key relationships
Work closely and collaboratively with members of clinical affairs (Clinical Project Leader, Senior CRA,CRA,Statistician)
Interface regularly with crossfunctional teams (R&D,Regulatory) as well as other functions across the organization as needed
Qualifications
Minimum Knowledge & Experience required for the position:
Bachelor's degree in life sciences or related field (Medical Technology, Biology.)
Minimum of 3 years clinical research experience in coordinating or monitoring Medical Device (IVD) Trials or working with a CRO
Strong understanding of GCP guidelines, International Conference on Harmonization (ICH) and regulatory requirements (FDA,IVDR)
Excellent understanding of clinical trial design
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Skills & Capabilities:
Demonstrates strong regulatory knowledge to maintain compliance across global studies.
Executes effective site monitoring and management, ensuring adherence to study protocols and timely issue resolution.
Maintains meticulous attention to detail in documentation, source data verification, and reporting to support high-quality outcomes.
Communicates clearly and professionally with investigators, sponsors, and cross-functional teams to foster collaboration and alignment.
Manages multiple projects and timelines efficiently, prioritizing tasks to meet study milestones and regulatory deadlines.
Adapts quickly to change, responding to evolving protocols, site needs, and regulatory updates with flexibility and composure.
Travel requirements:
Will vary by project. Travel requirement could be approx. 20%
Auto-ApplyClinical Research Associate II - Transplant and Transfusion
Clinical research coordinator job in Norcross, GA
A Clinical Research Associate II (CRA-II) plays a key role in monitoring and ensuring the integrity of clinical studies that evaluate the safety, performance, and effectiveness of medical devices and related products. This position supports the clinical operations function by ensuring compliance with applicable regulatory requirements and study protocols. By safeguarding data quality and patient safety, the CRA-II enables the organization to bring innovative healthcare solutions to market efficiently and ethically. The role adds value by bridging scientific research with operational excellence, ensuring studies are executed on time and to the highest quality standards
Responsibilities
Key Accountabilities
Conduct site qualification, initiation, monitoring, and close-out visits to ensure compliance with study protocols and regulatory requirements.
Serve as the primary point of contact between the sponsor and investigator sites, fostering effective communication and issue resolution.
Verify that investigator sites have adequate resources, qualified staff, and investigational products throughout the study lifecycle.
Ensure adherence to Good Clinical Practice (GCP), company SOPs, and applicable regulatory guidelines for all assigned studies.
Monitor data integrity by reviewing source documents, case report forms, and ensuring accurate and complete trial records.
Identify, document, and communicate protocol deviations, non-compliance, and safety issues promptly.
Assist in managing study timelines, budgets, and deliverables, escalating risks.
Prepare and maintain essential clinical trial documentation, including protocols, agreements, study reports, and site communications.
Assist with reagent inventory management - ordering, storage and dispostion of investigation products and study supplies
Uses the English language effectively in both written and verbal communication to convey complex clinical concepts with clarity and precision.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Networking/Key relationships
Work closely and collaboratively with members of clinical affairs (Clinical Project Leader, Senior CRA,CRA,Statistician)
Interface regularly with crossfunctional teams (R&D,Regulatory) as well as other functions across the organization as needed
Qualifications
Minimum Knowledge & Experience required for the position:
Bachelor's degree in life sciences or related field (Medical Technology, Biology.)
Minimum of 3 years clinical research experience in coordinating or monitoring Medical Device (IVD) Trials or working with a CRO
Strong understanding of GCP guidelines, International Conference on Harmonization (ICH) and regulatory requirements (FDA,IVDR)
Excellent understanding of clinical trial design
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Skills & Capabilities:
Demonstrates strong regulatory knowledge to maintain compliance across global studies.
Executes effective site monitoring and management, ensuring adherence to study protocols and timely issue resolution.
Maintains meticulous attention to detail in documentation, source data verification, and reporting to support high-quality outcomes.
Communicates clearly and professionally with investigators, sponsors, and cross-functional teams to foster collaboration and alignment.
Manages multiple projects and timelines efficiently, prioritizing tasks to meet study milestones and regulatory deadlines.
Adapts quickly to change, responding to evolving protocols, site needs, and regulatory updates with flexibility and composure.
Travel requirements:
Will vary by project. Travel requirement could be approx. 20%
Auto-ApplyClinical Research Associate - NAMSA Future Openings USA
Clinical research coordinator job in Atlanta, GA
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
Act with integrity in everything we do.
Provide best-in-class customer experiences.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.
Job Description:
• Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
• Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
• May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
• Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
• Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
• Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
• Performs study-related training.
• Manages the development and maintenance of study documents, processes and systems as assigned.
• Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.
• Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
• Attends internal and external meetings as required.
• Provides all job-related progress reports and visit documentation as required.
• May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
• OUS: Prepares and coordinates submissions to regulatory authorities.
• May perform other activities as assigned.
Qualifications & Technical Competencies:
• Fluency in English and local language, if different, required.
• Higher education degree or equivalent education, training, and experience.
• Preferred 2 years clinical trial experience.
• Preferred monitoring experience.
• Able to work independently once trained.
• Good verbal and written communication skills.
• Strong organizational skills.
• Basic computer proficiency.
• Understanding of clinical research processes and regulations.
• Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required
Working Conditions:
• Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
• Extensive use of a computer keyboard.
Pay Range Minimum:
$54,400.00
Pay Range Target:
$80,100.00
Pay Frequency:
Annual
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Fair Chance Employment Statement:
At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history.
Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position:
• May operate equipment
• Records data timely and accurately
• May analyze and interpret data
• Conducts studies on medical devices that have an impact on human life
A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
Auto-ApplySr. Clinical Study Manager - Device
Clinical research coordinator job in Atlanta, GA
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit ****************************
About Convatec
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit ****************************
About the role
This is a remote US-Based role, seeking someone residing in the Eastern Time Zone
Key Responsibilities:
* Proactively manage assigned clinical studies.
* Effectively manage clinical study delivery across the Clinical Study team during study start-up, routine monitoring, and closeout activities, demonstrating enthusiasm and innovation.
* Identify and escalate clinical study risks and propose solutions for risk mitigation.
* Oversee clinical study finance tracking, identify and escalate potential risks.
* Provide regular progress reports for clinical study activities through ongoing tracking and review of study project plans.
* Coordinate the production of key clinical study documentation, including Clinical Investigation Plan (CIP), Investigator Brochure (IB), Informed Consent Form (ICF) and Clinical Study Report (CSR).
* Motivate a multi-disciplinary clinical study team.
* Drive milestone achievement through management of study issues and conflict resolution with limited oversight.
* Oversee 3rd party Vendors where necessary to support milestone achievement.
* Build and develop relationships with key internal teams, including Medical Affairs and Medical Writing.
* Support audit and inspection activities as needed.
* Update processes and SOPs, providing input in discussions around quality by design and operational delivery.
* Demonstrate Convatec's core values.
* May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives.
Authority (if applicable):
Ability to provide recommendations and suggestions to ensure delivery of assigned clinical study(s).
Skills & Experience:
* Strong knowledge of the clinical study lifecycle.
* Clinical study management skills, including the ability to manage timelines, budgets and resources effectively.
* Medical Device experience essential.
* Keen attention to detail.
* Advanced knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
* Excellent collaborative team player.
* Experience in pre-market (IDE) and post-market clinical studies.
* Experience with Clinical Trial Management Systems.
Qualifications/Education:
* Bachelor's or Master's degree required, preferably in life sciences, medicine, or related discipline.
* Minimum of 10 years Clinical Research experience, preferably some within the medical device arena, with at least 5 years of experience in clinical study management. Years of experience may be considered in lieu of education.
Dimensions:
Principal Contacts & Purpose of Contact
Internal - Medical Affairs, Clinical Operations (Study Management, Site Management, Study Co-ordination, Data Analytics), Evidence Genertion, R&D
External - Vendors, Clinical Sites, Regulatory approvers (FDA, Competent Authorities, IRB/EC)
Travel Requirements
Position may involve travel up to 20% of the time, mostly domestic but some international travel may be required. Trips may include overnight travel.
Languages
* Speaking: Yes English
* Writing/Reading: Yes English
Working Conditions
Remote Working, however, occasional travel into the home office may be required.
Special Factors
Good working knowledge of Microsoft Suite including Office (Word,Excel,Powerpoint), Project, Teams
Flexibility to work across multiple time zones will be required.
Training will be provided at the Corporate, Department and Job Function level.
Ready to join us?
At Convatec, we're pioneering trusted medical solutions to improve the lives we touch. If you're ready to make a real impact, apply today and help us bring our Forever Caring promise to life.
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Beware of scams online or from individuals claiming to represent Convatec
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you're unsure, please contact us at ********************.
Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Already a Convatec employee?
If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!
Easy ApplyClinical Research Coordinator II
Clinical research coordinator job in Decatur, GA
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference
The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
How You'll Make An Impact
* Duties include but not limited to:
* Ability to understand and follow institutional SOPs.
* Review and assess protocol (including amendments) for clarity, logistical feasibility
* Ensure that all training and study requirements are met prior to trial conduct.
* Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
* Assist with planning and creation of appropriate recruitment materials
* Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
* Actively work with recruitment team in calling and recruiting subjects
* Attend Investigator meetings as required.
* Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
* Assist in the creation and review of source documents.
* Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
* Study Management
* Prioritize activities with specific regard to protocol timelines
* Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
* Maintain effective relationships with study participants and other care Access Research personnel.
* Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
* Communicate clearly verbally and in writing.
* Patient Coordination
* Prescreen study candidates
* Obtain informed consent per Care Access Research SOP
* Complete visit procedures in accordance with protocol.
* Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
* Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
* Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
* Documentation
* Record data legibly and enter in real time on paper or e-source documents
* Accurately record study medication inventory, medication dispensation, and patient compliance.
* Resolve data management queries and correct source data within sponsor provided timelines
* Assist regulatory personnel with completion and filing of regulatory documents.
* Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
The Expertise Required
* Excellent working knowledge of medical and research terminology
* Excellent working knowledge of federal regulations, good clinical practices (GCP)
* Ability to communicate and work effectively with a diverse team of professionals.
* Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
* Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
* Critical thinker and problem solver
* Friendly, outgoing personality; maintain a positive attitude under pressure.
* High level of self-motivation and energy
* Excellent professional writing and communication skills
* Ability to work independently in a fast-paced environment with minimal supervision.
Certifications/Licenses, Education, and Experience:
* Bachelor's Degree preferred, or equivalent combination of education, training and experience.
* A minimum of 3 years prior Clinical Research Coordinator experience required
* Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator
* Recent phlebotomy experience required
* Bilingual in Spanish-preferred
How We Work Together
* Location: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Decatur, GA clinic.
* Travel: Regularly planned travel within the region will be required as part of the role.
* Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members.
Benefits & Perks
* Paid Time Off (PTO) and Company Paid Holidays
* 100% Employer paid medical, dental, and vision insurance plan options
* Health Savings Account and Flexible Spending Accounts
* Bi-weekly HSA employer contribution
* Company paid Short-Term Disability and Long-Term Disability
* 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
Clinical Research Project Manager
Clinical research coordinator job in Kennesaw, GA
Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.
Position Objective:
The Clinical Research Project Manager is responsible for the management of assigned departmental project tasks/systems identified below in support of aortic arch repair technologies.
Responsibilities:
Liaison between Artivion, study sites, CROs, and other vendors (as applicable) to ensure study engagement and encourage transparent communication.
Management of clinical study sites to ensure that clinical trials are conducted in accordance with applicable standards and regulations.
Oversee project timelines, budgets, budget change forms, accruals, and monthly reports.
Support the development and amendment of the following documents: clinical protocol, study management plans, informed consent forms, case report forms, SOPs, etc.
Collect, query, analyze, and present clinical data and prepare internal and external study reports.
Conduct basic statistical analyses for technical support of product lines.
Conduct literature reviews and write research summaries related to product lines.
Interface with technical representatives, regional managers, and research teams for the purpose of technical training and addressing customer questions/concerns.
Communicate with customers and field staff regarding the planning of clinical trials, complaints, problems, and general correspondence.
Evaluate and report on adverse events and complaints associated with the product lines.
Attend surgical congresses in person or remotely, as necessary.
Coordinate the execution of peer-reviewed projects (publications, posters, abstracts) and marketing literature.
Support clinical strategy development for investigational device exemption (IDE) studies.
Participate in site recruitment/selection, investigator meetings, and site training.
Support the maintenance of any applicable clinical research databases as necessary.
Support the development of product Instructions for Use and assist with labeling and labeling changes.
Provide clinical support for marketing, regulatory, research and development, and quality departments.
Qualifications:
Bachelor's degree in biological science, engineering, or another science-related field
Minimum 2 years' experience planning and executing clinical research studies [or] relevant experience, or advanced degree with 1 years' experience
Experience overseeing multicenter investigational (e.g. IDE) studies is highly desirable.
Experience with aortic disease is highly desirable.
Demonstrate project management, critical thinking, and communication skills
Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications
Clinical Research Project Manager
Clinical research coordinator job in Kennesaw, GA
Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, *****************
Position Objective:
To support the successful execution of global clinical trials by ensuring regulatory compliance, managing site and vendor activities, maintaining data integrity, and contributing to high-quality clinical documentation. This role advances the development of innovative surgical implants for complex heart disease while collaborating cross-functionally and upholding international standards for patient safety and study quality.
Responsibilities:
* Supports regulatory submissions to competent authorities.
* May act as a site manager, and may provide site training.
* Interacts with sites in accordance with local law, standards, and regulations.
* Participates in vendor selection process.
* Works with vendor on contracts.
* Manages invoices.
* Collaborates on core clinical documents.
* Represents the core clinical documents and study processes to participating sites in the context of Site Regulatory Binders.
* Executes/supports clinical investigators with preparation and submission of required documentation to Institutional Review Boards (IRBs)/Ethics Committee (EC) for approval.
* Ensures maintenance of IRB/EC approval throughout the duration of the study.
* Provides training to clinical investigators and study personnel regarding protocol requirements, data collection and reporting requirements as necessary.
* Assists with developing Health Care Provider (HCP) presentations.
* May engage with cross functional teams.
* Facilitates queries for all missing or inaccurate data.
* Ensures that data changes are properly implemented and captured in the database or data system.
* Assists in the evaluation and analysis of clinical trial data.
* Disseminates publications to sites as necessary.
* Review clinical reports and conduct quality and consistency checks for regulatory submission and/or scientific publication.
* Learn the function and clinical applications of a surgical implant which treats complex heart disease conditions, understand the indication, safety, and performance objectives and parameters and ensure consistency across multiple clinical documents.
* Contribute to EU Medical Device Regulation processes and documentation generation and support submissions to Notified Bodies.
* Support ongoing Post-Market Surveillance and Quality Assurance activities
* Ability to travel domestically and internationally up to 30% of the time.
Qualifications:
* Bachelor's degree in biological science, engineering, or another science-related field
* Minimum 2 years' experience planning and executing clinical research studies [or] relevant experience, or advanced degree with 1 years' experience
* Experience overseeing multicenter investigational (e.g. IDE/ pre-CE) studies
* Demonstrate project management, critical thinking, and communication skills
* Proficient knowledge of medical terminology.
* Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications
Clinical Research Coordinator II
Clinical research coordinator job in Atlanta, GA
About Us:
Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Job Summary:
Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.
Essential Responsibilities and Duties:
Under supervision, coordinates aspects of patient involvement for complex and/or multiple studies from study initiation until study completion.
Organizes research information for clinical trials.
Observes subjects and assists with data analysis and reporting.
Schedules the collection of data.
Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately.
Monitors, and reports research data to maintain quality and compliance.
Performs administrative and regulatory duties related to the study as appropriate.
Participates in other protocol development activities.
Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)
Educates potential participants and caregivers on protocol specific details and expectations.
Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).
Assists Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes.
Assists the CTM in planning, creating processes, trainings and development of staff.
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills:
Must have proper experience and demonstrate mastery of Clinical Research Coordinator I position.
High school graduate or equivalent; Bachelors Degree, preferred
CCRC certification preferred
2-3 years of experience in the medical field, preferred
Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials.
Strong leadership and mentorship skills.
Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level.
Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.
Works independently as well as functioning as part of a team.
Must be able to effectively communicate verbally and in writing.
Working Conditions
Indoor, Office environment.
Shift work, depending on location.
Essential physical requirements include sitting, typing, standing, and walking.
Lightly active position, occasional lifting of up to 20 pounds.
Reporting to work, as scheduled, is essential.
Overnight travel may be required for training and/or investigative meetings.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
Clinical Research Coordinator - PRN/ Contractor
Clinical research coordinator job in Sandy Springs, GA
M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.
Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.
Due to our continued growth, we are hiring for a contract
Clinical Research Coordinator
at
Wake Research,
an M3 company. This is an on-site position.
A Clinical Research Coordinator (contract/PRN) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial.
Essential services to be performed:
Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses.
Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management.
Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures.
Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria.
Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials.
Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc.
In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed.
Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents.
Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review.
Assists with timely completion of case report forms, if appropriately delegated/trained.
Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability.
Assists fellow co-workers with studies as time and ability permits.
Qualifications
Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
Successful completion of the GCP certification.
Phlebotomy and EKG experience.
+2 years of CRC experience is preferred.
Additional Information
About M3:
M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.
Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.
Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.
Benefits:
A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:
401(k), 401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance
*M3 reserves the right to change this job description to meet the business needs of the organization
#LI-Onsite
#LI-LB1
Clinical Research Coordinator - PRN/ Contractor
Clinical research coordinator job in Sandy Springs, GA
M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.
Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.
Due to our continued growth, we are hiring for a contract Clinical Research Coordinator at Wake Research, an M3 company. This is an on-site position.
A Clinical Research Coordinator (contract/PRN) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial.
Essential services to be performed:
Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses.
Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management.
Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures.
Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria.
Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials.
Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc.
In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed.
Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents.
Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review.
Assists with timely completion of case report forms, if appropriately delegated/trained.
Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability.
Assists fellow co-workers with studies as time and ability permits.
Qualifications
Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
Successful completion of the GCP certification.
Phlebotomy and EKG experience.
+2 years of CRC experience is preferred.
Additional Information
About M3:
M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.
Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.
Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.
Benefits:
A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:
401(k), 401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance
*M3 reserves the right to change this job description to meet the business needs of the organization
#LI-Onsite
#LI-LB1
Cardiology Research Nurse Manager
Clinical research coordinator job in Atlanta, GA
Northside Hospital is award-winning, state-of-the-art, and continually growing. Constantly expanding the quality and reach of our care to our patients and communities creates even more opportunity for the best healthcare professionals in Atlanta and beyond. Discover all the possibilities of a career at Northside today.
Responsibilities
The Research Nursing Manager is responsible for overseeing nursing operations, including the Northside Hospital Heart Institute
or
Northside Hospital Cancer Institute Research Network. This role will be responsible for the day-to-day management and oversight of the quality and validity of clinical research data and research patient care and will oversee the work of the Lead Research Coordinators, Clinical Research Nurses (CRN), the Clinical Research Coordinators (CRC), Data Management and regulatory staff.
PRIMARY DUTIES AND RESPONSIBILITIES
Oversee Cardiology or Oncology research nursing and maintain awareness of all relevant clinical research projects.
Ensure clinical and regulatory quality and integrity of research conducted.
Develop and implement training programs for CRN, CRC, Data Management Staff and Regulatory staff.
Manage special projects to expand the capabilities of the Research Program or as assigned.
Identifies the needs of those service areas and individuals served by the department and assists in the development of goals, objectives, policies, and procedures to align with strategic initiatives.
Serve as a member or leader of appropriate committees and work groups.
Develop, implement, and analyze work flow procedures to maximize productivity and coordinate with other clinical areas to ensure system effectiveness.
Prepare periodic reports of operations to include workload statistics and staffing needs; assists in development of workload standards and ongoing monitoring of standards to ensure adequate staff levels.
Monitor all clinical research activity and maintain awareness of all clinical research projects.
Develop, maintain, and evaluate SOPs for administering clinical research.
Recruit, hire, orient, and evaluate performance of assigned personnel to assure that department is staffed with individuals who reflect behavior and performance consistent with the hospital's Mission and Values statement. Has authority to hire, terminate and/or take other disciplinary action as may be deemed appropriate and is in accordance with hospital policy
Develop and submit to Director for approval, appropriate capital and operating budget and is accountable for the achievement of capital and operating budget objectives.
Qualifications
KNOWLEDGE SKILLS AND ABILITIES/LICENSE OR CERTIFICATION REQUIRED
Bachelor's degree in nursing.
Licensed as a RN in the state of Georgia in good standing, without limitations
Minimum of three (3) years of experience in a clinical research setting.
Minimum of two (2) years of experience in area of specialty nursing.
Minimum of one (1) year experience managing employees.
Work Hours: 8a - 4:30p Weekend Requirements: No On-Call Requirements: No
Auto-ApplyCardiology Research Nurse Manager
Clinical research coordinator job in Atlanta, GA
We are seeking an experienced Cardiology Research Nurse Manager to lead our growing cardiology clinical research program. This is a newly created position, offering the opportunity to shape and expand a high-impact research initiative. The ideal candidate will have a strong background in cardiology research and team management, as well as a passion for advancing cardiovascular care through clinical trials.
Schedule and Responsibilities
Monday - Friday schedule in a clinical research setting
Lead and oversee cardiology clinical trials from Phase I to Phase IV
Manage and support a team of research nurses and coordinators
Ensure compliance with regulatory guidelines and research protocols
Collaborate with physicians, sponsors, and interdisciplinary teams to drive research initiatives
Oversee patient enrollment, study execution, and data collection
Maintain high standards of patient care and safety throughout all trials
Position Details
Salaried leadership position with a focus on program growth and team development
Based in Atlanta with ongoing oversight of 20-30 active cardiology trials
Key role in the expansion and development of cardiology research within the organization
Why Choose Us?
People & Culture
Experience a workplace where colleagues become family
Join a team known for its strong culture and long-term employee retention
Work in an environment where you'll look forward to coming in each day
Unmatched Benefits
Competitive salary with a generous pension plan (approximately 9% annual contribution)
Unique offerings, including student loan repayment assistance
Comprehensive benefits package with an industry-leading cost-to-coverage ratio
Tailored perks that prioritize your well-being and financial security
Career Growth & Clinical Ladder
Personalized placement to align with your strengths and career goals
Robust clinical ladder for specialization and leadership advancement
Proactive internal mobility support to help you find your ideal role
Career mapping tools for clear and transparent professional development
Priority consideration for internal candidates seeking career progression
Year-round residency programs with experience-based pay
Succession Planning & Leadership Development
Comprehensive training and mentorship programs to support career growth
Strong internal pipeline fostering leadership development
Over 90% of leadership positions filled through internal promotions
A commitment to providing exceptional service to patients and their families
A workplace that goes above and beyond for employees, fostering a positive and supportive work environment
If you are an experienced RN with a background in cardiology research and leadership, we invite you to join our growing research team.
Apply Today
Clinic Coordinator - Atlanta, GA
Clinical research coordinator job in Atlanta, GA
Clinic Coordinator - Patient Experience & Sales
Are you a natural leader with a heart for people and a talent for communication? Do you thrive in a fast-paced environment where every interaction can make someone's day better? Are you passionate about health, wellness, and inspiring others to invest in their well-being?
At The Joint Chiropractic, we believe leadership is not just about titles - it's about influence, service, and the ability to inspire excellence in others. As our Clinic Coordinator, you will work closely with leadership to ensure every patient feels seen, valued, and cared for - while helping guide and develop a high-performing front desk team that consistently delivers a beyond 5-star patient experience.
This is a role for someone who doesn't just want a job - but wants to make an impact. You'll combine leadership, communication, and patient advocacy with sales expertise to help more people experience the benefits of chiropractic care, while partnering with management to build a motivated, engaged team culture that thrives on excellence.
What You'll Do (in collaboration with leadership):
Lead by example in delivering exceptional patient care, ensuring each visit is smooth, personalized, and uplifting.
Assist in training, coaching, and motivating front desk team members so they're confident, capable, and committed to our mission.
Help oversee daily clinic flow, anticipating needs, solving problems quickly, and ensuring operations run with precision and warmth.
Build strong, lasting relationships with patients - remembering their stories, celebrating their progress, and helping them stay engaged in their care plans.
Confidently present and recommend membership and wellness packages that align with patient goals, supporting both their health journey and clinic growth.
Support the team in upholding The Joint's core values of Trust, Integrity, Excellence, Respect, and Accountability while contributing to a positive, professional atmosphere.
Partner with the Clinic Director and Doctors to ensure our patient experience is consistently exceptional from check-in to checkout.
Participate in marketing and community outreach efforts to bring new patients into the clinic.
What We're Looking For:
A people-first leader who naturally inspires trust, respect, and enthusiasm.
Exceptional verbal and written communication skills - confident, clear, and warm in every interaction.
At least one year of sales experience, preferably in a health, wellness, or service-based industry.
Proven ability to work as part of a leadership team to motivate and guide others toward ambitious goals.
Strong organizational skills with the ability to manage multiple priorities and maintain calm under pressure.
A passion for health and wellness - chiropractic experience is a plus, but not required.
Availability to work Saturdays as needed.
Why You'll Love This Role:
Competitive pay $15-$18/hr + Bonus Opportunities.
Opportunities for growth and advancement within a rapidly expanding organization.
A collaborative leadership role where you'll work alongside management to shape team performance and patient experience.
The chance to help people live healthier, more active lives every single day.
About The Joint Chiropractic
The Joint Corp. revolutionized access to chiropractic care when it introduced its retail healthcare business model in 2010. Today, it is the nation's largest operator, manager and franchisor of chiropractic clinics through
The Joint Chiropractic
network. The company is making quality care convenient and affordable, while eliminating the need for insurance, for millions of patients seeking pain relief and ongoing wellness. With more than 700 locations nationwide and nearly 11 million patient visits annually,
The Joint Chiropractic
is a key leader in the chiropractic industry. Ranked number one on
Forbes'
2022 America's Best Small Companies list, number three on
Fortune's
100 Fastest-Growing Companies list and consistently named to
Franchise Times
“Top 400+ Franchises” and
Entrepreneur's
“Franchise 500 ” lists,
The Joint Chiropractic
is an innovative force, where healthcare meets retail. For more information, visit *****************
Business Structure
The Joint Corp. is a franchisor of clinics and an operator of clinics in certain states. In Arkansas, California, Colorado, District of Columbia, Florida, Illinois, Kansas, Kentucky, Maryland, Michigan, Minnesota, New Jersey, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Washington, West Virginia and Wyoming, The Joint Corp. and its franchisees provide management services to affiliated professional chiropractic practices.
You are applying to work with a franchisee of The Joint Corp. If hired, the franchisee will be your only employer. Franchisees are independent business owners who set own terms of employment, including wage and benefit programs, which can vary between franchisees.
Auto-ApplyClinical Research Coordinator II
Clinical research coordinator job in Decatur, GA
Job Description
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like
Future of Medicine
, which makes advanced health screenings and research opportunities accessible to communities worldwide, and
Difference Makers
, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference
The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
How You'll Make An Impact
Duties include but not limited to:
Ability to understand and follow institutional SOPs.
Review and assess protocol (including amendments) for clarity, logistical feasibility
Ensure that all training and study requirements are met prior to trial conduct.
Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
Assist with planning and creation of appropriate recruitment materials
Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
Actively work with recruitment team in calling and recruiting subjects
Attend Investigator meetings as required.
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Assist in the creation and review of source documents.
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
Study Management
Prioritize activities with specific regard to protocol timelines
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
Maintain effective relationships with study participants and other care Access Research personnel.
Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
Communicate clearly verbally and in writing.
Patient Coordination
Prescreen study candidates
Obtain informed consent per Care Access Research SOP
Complete visit procedures in accordance with protocol.
Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
Documentation
Record data legibly and enter in real time on paper or e-source documents
Accurately record study medication inventory, medication dispensation, and patient compliance.
Resolve data management queries and correct source data within sponsor provided timelines
Assist regulatory personnel with completion and filing of regulatory documents.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
The Expertise Required
Excellent working knowledge of medical and research terminology
Excellent working knowledge of federal regulations, good clinical practices (GCP)
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
Critical thinker and problem solver
Friendly, outgoing personality; maintain a positive attitude under pressure.
High level of self-motivation and energy
Excellent professional writing and communication skills
Ability to work independently in a fast-paced environment with minimal supervision.
Certifications/Licenses, Education, and Experience:
Bachelor's Degree preferred, or equivalent combination of education, training and experience.
A minimum of 3 years prior Clinical Research Coordinator experience required
Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator
Recent phlebotomy experience required
Bilingual in Spanish-preferred
How We Work Together
Location: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Decatur, GA clinic.
Travel: Regularly planned travel within the region will be required as part of the role.
Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members.
Benefits & Perks
Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
Clinical Research Coordinator - PRN/ Contractor
Clinical research coordinator job in Sandy Springs, GA
M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.
Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.
Due to our continued growth, we are hiring for a contract Clinical Research Coordinator at Wake Research, an M3 company. This is an on-site position.
A Clinical Research Coordinator (contract/PRN) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial.
Essential services to be performed:
Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses.
Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management.
Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures.
Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria.
Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials.
Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc.
In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed.
Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents.
Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review.
Assists with timely completion of case report forms, if appropriately delegated/trained.
Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability.
Assists fellow co-workers with studies as time and ability permits.
Qualifications
Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
Successful completion of the GCP certification.
Phlebotomy and EKG experience.
+2 years of CRC experience is preferred.
Additional Information
About M3:
M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.
Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.
Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.
Benefits:
A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:
401(k), 401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance
*M3 reserves the right to change this job description to meet the business needs of the organization
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