Clinical research coordinator jobs in Athens, GA - 183 jobs
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Clinical Research Associate
Nutramax Laboratories 4.0
Clinical research coordinator job in Lancaster, SC
Nutramax desires to provide a drug-free, healthful, and safe workplace. We hold a zero-tolerance policy for drug use. Employment is contingent upon successfully passing a preemployment background check and drug screen (subject to applicable law).
This position is 100% on site in our Lancaster, SC Headquarters (roughly 45 min - 1 hour south of Charlotte, NC).
Summary of the Position: The ClinicalResearch Associate is responsible for assisting in clinical trials from initiation to completion through participating in the development of study protocols, case report forms and clinical reports, as well as performing site monitoring visits and interfacing with site staff, ClinicalResearch Organizations (CRO), and other company representatives. This position is also responsible for supporting clinical trials as required.
Roles and Responsibilities:
· Facilitate the development of study protocols, reports, SOPs, NDAs and research agreements by coordinating input from various sources including literature, experts, and internal team members.
· Coordinates and conducts study protocol training at study sites and appropriate documentation.
· Select and manage investigational sites and clinical trial vendors such as CROs and external laboratories.
· Facilitate the development of study documentation including case report forms, informed consent forms, source documentation and study-specific plans for sound and thorough data to support the approval process or study objective.
· Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols.
· Assure procedures are in adherence with the assigned study protocol and in accordance with good clinicalresearch principals.
· Monitors clinical studies and provides reports throughout study execution.
· Perform quality checks on data, analytical results, study procedures and materials.
· Obtain and coordinate results of information from blood samples and laboratory analysis as described in study protocol.
· Prepare data for statistical analysis.
· Assist in preparation of final study reports, scientific abstracts and manuscripts for publication.
· Represent company at veterinary conferences and trade shows.
· Communicate effectively with other departments within the organization and function within a team environment.
· Review journals, abstracts and scientific literature to keep abreast of new developments.
· Perform other Clinical Operations duties, as requested
Minimum Requirements: Basic knowledge of scientific principles and practices. Excellent writing, interpersonal, communication, and organization skills required. Must be detail oriented and work collaboratively with internal and external teams. Must be proficient in computer usage, such as word processing, spreadsheets, and/or databases. Knowledge of MS Access desired. Experience with Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs) regulations, and Standard Operating Procedures (SOPs), a PLUS. Some travel required for monitoring clinical studies, attending conferences and trade shows (20% travel required).
Education and Experience: Master's degree or bachelor's degree with equivalent experience required, preferably in animal science, biology, veterinary, or related life sciences. Certifications such as CVT, LVT, RVT, or CVPM.
Supervisory Responsibilities: None
$54k-82k yearly est. 2d ago
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Clinical Research Coordinator III
Denali Health 3.8
Clinical research coordinator job in Stone Mountain, GA
Denali Health is a fast-growing clinicalresearch 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 ClinicalResearchCoordinator III (CRC III) is responsible for leading the coordination and execution of complex clinicalresearch 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 clinicalresearchcoordination.
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 clinicalresearch 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
“ClinicalResearchCoordinator III - Stone Mountain.”
$45k-67k yearly est. 2d ago
Neuroscience Research Coordinator
Kennesaw State University 4.3
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.
*****************************************************************************************
$44.2k yearly Easy Apply 40d ago
Research Coordinator - CAN Lab
University of Georgia 4.2
Clinical research coordinator job in Athens, GA
Information Classification Title Research Paraprofessional/Professional FLSA Non-Exempt FTE 1.00 Minimum Qualifications Requires technical knowledge in the field acquired through an apprenticeship, a 2-year degree, or professional certificate. Please contact your Human Resources office for an evaluation of education/experience in lieu of the required minimum qualifications.
Preferred Qualifications Position Summary
This researchcoordinator position is within the Clinical Affective Neuroscience lab directed by Dr. Gregory Strauss. The researchcoordinator will be involved in the clinical aspects of the research program and coordinating day-to-day responsibilities for the research protocol.
Knowledge, Skills, Abilities and/or Competencies
* Basic understanding and knowledge of scientific/medical terminology and research.
* Skill in statistical interpretation and data analysis using Excel, Access, SPSS, as well as other word processing, spreadsheet and database management software applications.
* Detail oriented person who understands the importance accountability in research.
* Ability to work as part of a team.
* Excellent organizational and project management skills.
* Excellent communication skills in order to interview research volunteers to determine study eligibility, to interact with staff from various programs and institutions, and to conduct experimental sessions.
* Ability to independently perform or lead research activities.
* Ability to participate in the design of research studies and preparation of technical procedures and reports.
Physical Demands
Sitting, standing, walking, bending, stooping, pushing, pulling, lifting up to 20 lbs and carrying up to 20 lbs.
Is driving a responsibility of this position? No Is this a Position of Trust? Yes Does this position have operation, access, or control of financial resources? Yes Does this position require a P-Card? No Is having a P-Card an essential function of this position? No Does this position have direct interaction or care of children under the age of 18 or direct patient care? Yes Does this position have Security Access (e.g., public safety, IT security, personnel records, patient records, or access to chemicals and medications) No Credit and P-Card policy
Be advised a credit check will be required for all positions with financial responsibilities. For additional information about the credit check criteria, visit the UGA Credit Background Check website.
Background Investigation Policy
Offers of employment are contingent upon completion of a background investigation including, a criminal background check demonstrating your eligibility for employment with the University of Georgia; confirmation of the credentials and employment history reflected in your application materials (including reference checks) as they relate to the job-based requirements of the position applied for; and, if applicable, a satisfactory credit check. You may also be subject to a pre-employment drug test for positions with high-risk responsibilities, if applicable. Please visit the UGA Background Check website.
Duties/Responsibilities
Duties/Responsibilities
Coordinates with principal investigator to help ensure that clinicalresearch and related activities are performed in accordance with federal and university regulations, sponsored agency policies, and procedures.
Percentage of time 40 Duties/Responsibilities
Responsible for scheduling, recruitment, interviewing participants, performing neuropsychological and computerized testing (collecting clinical, cognitive, and fMRI data). This involves being responsible for handling petty cash for research participant incentives.
Percentage of time 40 Duties/Responsibilities
Supervising data entry for the UGA site, uploading it to the online system, and coordinating with the lab coordinator at the other sites.
Percentage of time 20
Contact Information
Recruitment Contact
Contact Details
For questions concerning this position or recruitment progression, please refer to the Recruitment Contact listed below.
Recruitment Contact Name Greg Strauss Recruitment Contact Email **************** Recruitment Contact Phone
Posting Specific Questions
Required fields are indicated with an asterisk (*).
Applicant Documents
Required Documents
* Resume/CV
* Cover Letter
Optional Documents
Persons needing accommodations or assistance with the accessibility of materials related to this search are encouraged to contact University HR (*************).
The University of Georgia is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, genetic information, national origin, race, religion, sex, or veteran status or other protected status.
$48k-68k yearly est. Easy Apply 60d+ ago
Clinical Research Associate
Icon Plc 4.8
Clinical research coordinator job in Georgia
ClinicalResearch Associate/Senior ClinicalResearch Associate/CRA ICON plc is a world-leading healthcare intelligence and clinicalresearch organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Senior ClinicalResearch Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.
What You Will Be Doing:
* Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
* Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
* Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
* Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
* Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
Your Profile:
* Advanced degree in a relevant field such as life sciences, nursing, or medicine.
* Extensive experience as a ClinicalResearch Associate, with a strong understanding of clinical trial processes and regulatory requirements.
* Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
* Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
* Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
#LI-TK1
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family's needs.
* Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
* Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
* Life assurance
* Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
$51k-74k yearly est. 7d ago
Clinical Research Associate - NAMSA Future Openings USA
Namsa 4.2
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 clinicalresearch processes and regulations.
• Certifications such as Society of ClinicalResearch Associates (SoCRA) or Association of ClinicalResearch Professionals (ACRP) Certification preferred but not required
Working Conditions:
• Up to 20% travel for In-House ClinicalResearch Associates; up to 80% travel for Field ClinicalResearch 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.
$54.4k-80.1k yearly Auto-Apply 57d ago
Associate Directer, Clinical Research
TJ Consulting Group
Clinical research coordinator job in Lancaster, SC
Seeking an experienced Associate Director of ClinicalResearch to lead and oversee clinical trials for products regulated by the FDA. This role requires deep experience in managing clinical trial phases within pharmaceutical or supplement companies.
Responsibilities
Oversee and manage clinicalresearch programs from planning through completion
Ensure compliance with FDA regulations and GCP guidelines
Lead cross-functional teams and external research partners
Review and analyze clinical data and reporting
Contribute to regulatory strategy and submissions
Qualifications
Extensive experience in clinicalresearch within FDA-regulated environments
Prior experience managing clinical trials for pharmaceutical or supplement products
Strong leadership, analytical, and regulatory knowledge
We are committed to fostering an inclusive workplace and provides equal employment opportunities (EEO) to all employees and applicants for employment. We do not employ AI tools in our decision-making processes. Regardless of race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran. ensures that all employment decisions are made in accordance with applicable federal, state, and local laws. Our commitment to non-discrimination in employment extends to every location in which our company operates.
$50k-79k yearly est. 6d ago
Research Associate - Clinical Trials Office
Augusta University 4.3
Clinical research coordinator job in Augusta, GA
* About Us Augusta University is Georgia's innovation center for education and health care, training the next generation of innovators, leaders, and healthcare providers in classrooms and clinics on four campuses in Augusta and locations across the state. More than 10,500 students choose Augusta for educational opportunities at the center of Georgia's cybersecurity hub and experiential learning that blends arts and application, humanities, and the health sciences. Augusta is home to Georgia's only public academic health center, where groundbreaking research is creating a healthier, more prosperous Georgia, and world-class clinicians are bringing the medicine of tomorrow to patient care today. Our mission and values ***************************************** make Augusta University an institution like no other.
Augusta University's distinct characteristics in education and research include real-world experiences and community engagement, as well as a culture of building community, corporate and government partnerships that address health, security, economic and societal concerns locally and across the state.
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 online at **************************************************************************
Additionally, USG supports Freedom of Expression as stated in Board Policy 6.5 Freedom of Expression and Academic Freedom found online at ************************************************
Location
Augusta University
Our Health Sciences Campus: 1120 15th Street, Augusta, GA 30912
Our Summerville Campus: 2500 Walton Way, Augusta, GA 30904
College/Department Information
Augusta University is actively participating in ways to improve the health and lives of the people of our community, our state, and around the world. To do this, we conduct research, a great deal of which is done through clinical trials in humans (known as human subject research). There are many federal requirements that all research institutions must meet in order to conduct human subject research. We have an outstanding, dynamic, and growing group of researchers, administrators, and office staff ready to assist. Our defined strengths lie in the areas of: Conventional clinical trials; Community, population health, social, behavioral, and educational research; Community education; Well-defined research initiation process; Ongoing and continued support for conduct of research; Integrated and technology advanced IT systems to support efficient research processes.
Job Summary
The Research Associate conducts research responsibilities for assigned studies. Be familiar with study protocols, assist investigators with recruiting patient studies. Screen potential patients, help enroll and randomize patients with into studies. Collect and enter study data, prepare and maintain regulatory documents, resolve data queries. Schedule patient visits and procedures, perform or assist with venipuncture, prepare specimens for shipment. This position will provide assistance to the overall functioning activities of the Clinical Trials Office (CTO).
Responsibilities
Responsibilities to include, but are not limited to:
Coordination of clinicalresearch trials to include meeting with drug and device company representatives, screening, recruiting and consenting patients, scheduling follow-up appointments, coordinating care with other departments, and performing all laboratory and other tests as required by the protocol.
Attend meetings, computer training, and workshops as requested.
Keep investigator informed of patients' condition and provide assistance to investigators in the management of adverse events.
Receive and respond to all correspondence received in a timely manner.
Complete all reports including the annual study continuation report in a timely manner ' accurately communicate all necessary information to patients, families, investigators, sponsors, IRB, and institutional entities.
Responsible for collection, processing, storage, and inventory of specimens for specific studies, assessing for adverse events, maintaining investigational devices, staff development and completion of regulatory paperwork as required by the FDA, study sponsor, and institutional policies and procedures for all assigned studies as well as the Annual IRB Continuation Reports and other IRB activities as requested.
Maintain all FDA, sponsor, and institutional review board documentation. Obtain and maintain complete source documentation. Accurate and timely completion of all case report forms and other data entry as required by the sponsor and local institutional data management programs.
Enter data into the OnCore research data management system as dictated per institutional policy as well as the Greenphire patient debit system.
Review study bills received for accuracy ensuring that the correct codes are used and the correct amount is billed according to the billing grid for that study in a timely manner.
Perform all other related duties as assigned.
Required Qualifications
Master's degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and experience in research, basic science or clinical laboratory particularly clinical trial research.
OR
Bachelor's degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and a minimum of three years' research and/or clinical experience.
Knowledge, Skills, & Abilities
KNOWLEDGE
Proficient in Microsoft Office and other computer software/databases.
SKILLS
Excellent interpersonal, written, and verbal communication skills.
Detail-oriented with strong multi-tasking and prioritization.
ABILITIES
Ability to maintain confidentiality.
Ability to recognize potential adverse events and follow SOPs for reporting of such.
Ability to follow protocols as designed, remember protocols, and communicate with patients.
Ability to adapt workflow to accommodate study amendments and principal investigator directions.
Ability to work as a team player and adjust daily schedule in order to accommodate patient and investigator schedules.
Must be willing to work flexible hours which may include early mornings, after hours, nights and weekends which may include up to two weeks on call per month.
Ability to communicate clearly at all times, convey information in a professional manner which will most often involve sensitive patient data or other information. Must be able to communicate in non-abrasive manner.
Shift/Salary/Benefits
Shift: Days; Monday - Friday (Work outside of normal business hours may be required).
Salary Range: $45,400-$56,700 annually.
Pay Band: B8
Salary to be commensurate with qualifications of the selected candidate within the established range (generally minimum-midpoint) of the position.
Recruitment Period: Until Filled.
Augusta University offers a variety of benefits to full-time benefits-eligible employees and some of our half-time (or more) employees.
Benefits that may be elected could include health insurance, dental insurance, life insurance, Teachers Retirement System (or Optional Retirement Plan), as well as earned vacation time, sick leave, and 13 paid holidays.
Also, our full-time employees who have been employed with us successfully for more than 6 months can be considered for the Tuition Assistance Program. Consider applying with us today!
Conditions of Employment
All selected candidates are required to successfully pass a Background Check review prior to starting with Augusta University.
If applicable for the specific position based on the duties: the candidate will also need to have a credit check completed for Positions of Trust and or approved departmental Purchase Card usage.
Motor vehicle reports are required for positions that are required to drive an Augusta University vehicle.
For Faculty Hires: Final candidates will be required to provide proof of completed academic degree(s) as well as post-secondary coursework in the form of original transcript(s). Those candidates trained by a foreign institution will also be required to provide an educational/credential evaluation.
All employees are responsible for ensuring the confidentiality, availability, and integrity of sensitive [patient, student, employee, financial, business, etc.] information by exercising sound judgment and adhering to cybersecurity and privacy policies during their employment and beyond.
Other Information
This position is also responsible for promoting a customer-friendly environment and providing superior service to our patients, students, faculty, and employees. "Augusta University is a patient-and family-centered care institution, where employees partner every day with patients and families for success."
Augusta University is a tobacco-free environment, and the use of any tobacco products on any part of the campus, both inside and outside, is strictly prohibited.
Equal Employment Opportunity
Augusta University is proud to be an equal opportunity employer, welcoming applicants from underrepresented groups, including individuals with disabilities and veterans.
How To Apply
Consider applying with us today!
******************************** Search for Job ID: 288933.
Select University Faculty & Staff > External Applicants if you are a candidate from outside the university.
Select University Faculty & Staff > Internal Applicants if you are a current university employee.
If you need further assistance, please contact us at ************.
$45.4k-56.7k yearly 60d+ ago
Clinical Research Associate II - Transplant and Transfusion
Associate Project Manager In Bedford, Massachusetts
Clinical research coordinator job in Norcross, GA
Introduction
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care
Overview
A ClinicalResearch 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 clinicalresearch 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%
Closing
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact ****************************** for assistance.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.
**************
$50k-80k yearly est. Auto-Apply 60d+ ago
Clinical Research Associate II - Transplant and Transfusion
Werfen
Clinical research coordinator job in Norcross, GA
Introduction
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care
Overview
A ClinicalResearch 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 clinicalresearch 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%
Closing
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact ****************************** for assistance.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.
**************
$50k-80k yearly est. Auto-Apply 60d+ ago
Senior Clinical Research Coordinator
Alliance for Multispecialty Research
Clinical research coordinator job in Myrtle Beach, SC
The Senior ClinicalResearchCoordinator will perform and manage tasks that are critical to clinicalresearch studies. The Senior ClinicalResearchCoordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinicalresearch study.
To consistently embody AMR Clinical's Core Values:
United We Achieve
Celebrate Diverse Perspectives
Do the Right Thing
Adapt and Persevere
The ClinicalResearchCoordinator reports to the Site Manager/Team Lead.
Classification: Non-Exempt
Primary Responsibilities:
Expanded role in team management, mentorship, and training, which includes over-sight of level 1 CRC's, Research Assistants and ancillary staff.
Advanced Problem Solving & Decision-Making. Takes ownership of identifying, analyzing, and resolving complex study-related challenges, including protocol deviations, regulatory compliance issues, and operational inefficiencies. Proactively collaborates with QA and Site Manager to develop and implement corrective and preventive action plans to mitigate risks and improve study outcomes. Serves as a key resource for junior staff, providing guidance and training on problem-solving strategies while escalating critical issues to leadership as needed.
Advanced knowledge of protocol and procedures.
Greater responsibility for regulatory compliance, protocol deviations, and audits.
Deeper involvement in recruitment strategy and study performance.
Higher engagement with study sponsors, CROs, monitors/CRA's, IRBs, laboratories, and clinical personnel within the research industry.
Coordinateclinical trials per FDA requirements and GCP Guidelines per sponsor protocols.
Establish understanding of SOP's and implement the SOP's
Gain understanding of the pharmaceutical drug per clinical trial.
Advanced skills in study start-up and close-out procedures.
Manage complex clinical trials, including those with challenging study designs and special patient populations.
Work closely with Investigators to optimize site performance, improve study compliance, and facilitate better communication between research staff and investigators.
Notify the correct personnel of any adverse events per the study protocol (PI, Sub-I, monitor/CRA, etc.)
Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinicalresearch study.
Establish and maintain patient rapport.
Clinical data collection (vital signs, EKG recording, weight, height, etc.)
Obtain medical records and review as required.
Phlebotomy
Specimen collection, processing, and storage
Transporting clinical specimens to laboratory.
Educate subjects on diaries and oversees compliance with diary completion.
Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.)
Responsible for completing patient phone call visits in accordance to the standard protocol period.
Ensure documentation follows ALCOA standards and is completed in a timely manner.
Ensure all necessary documents are completed, signed and dated.
Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required.
Manage study inventory and order supplies as needed.
Prepare and assist study monitors during onsite visits.
Maintain familiarity with all ongoing clinicalresearch studies.
Travel to Investigator meetings as needed.
Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties
Mentor team members to promote professional development
Position may require occasional weekend and/or overtime hours.
Other duties as assigned
Desired Skills and Qualifications:
3+ years of experience in clinicalresearch.
Completion of formal medical training, educational program, or healthcare experience
Strong medical terminology
Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.).
Ability to work independently and lead study-related tasks.
Ability to multi-task in a high-paced evolving environment.
Exceptional listening, written, and verbal communication skills as well.
Demonstrate proficiency in office equipment and software programs.
Excellent organizational and task management skills.
Ability to be ambulatory most of the workday.
Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.
AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.
** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.
$42k-64k yearly est. Auto-Apply 3d ago
UNIV - Research Study Coordinator - Hollings Cancer Center
MUSC (Med. Univ of South Carolina
Clinical research coordinator job in Charleston, SC
Under general supervision of the Clinical Trials Office (CTO) and specific disease group Program Manager within the Clinical Operations Unit, this position coordinates, establishes, and supervises complex research protocols at the Hollings Cancer Center (HCC) to efficiently and effectively integrate the National Cancer Institute (NCI), investigator initiated and industry sponsored oncology trials at the Medical University of South Carolina (MUSC). Actively promotes and increases awareness of the clinical trial program within HCC, exercises judgment regarding proper study participant management.
Entity
Medical University of South Carolina (MUSC - Univ)
Worker Type
Employee
Worker Sub-Type
Classified
Cost Center
CC001332 HCC CTO Administration
Pay Rate Type
Hourly
Pay Grade
University-05
Pay Range
39,764.00 - 56,670.00 - 73,576.000
Scheduled Weekly Hours
40
Work Shift
Under general supervision of the Clinical Trials Office (CTO) and specific disease group Program Manager within the Clinical Operations Unit, this position coordinates, establishes, and supervises complex research protocols at the Hollings Cancer Center (HCC) to efficiently and effectively integrate the National Cancer Institute (NCI), investigator initiated and industry sponsored oncology trials at the Medical University of South Carolina (MUSC). Actively promotes and increases awareness of the clinical trial program within HCC, exercises judgment regarding proper study participant management.
Responsibilities:
35% Coordinates patient research related activities to accurately meet protocol requirements.
Ensure protocol compliance for study participants. Ensures database updates to reflect accurate patient status. Utilizes office tools including Sharepoint, Clinical Data Center (CDC), and clinical trial management system (CTMS). Provides protocol specific information to physicians, primary nurses, and patients. Coordinates the clinical work-up to determine patient eligibility. Coordinates treatment plan and required follow-up with study participant, medical staff, nursing staff and ancillary hospital personnel. Ensures that follow-up requirements per protocol are carried out in order to assess for response to treatment. Works closely with clinical nurse staff to coordinate patient care to meet protocol standards. Consults with the investigator to assess study participant for response to protocol therapy including toxicity assessment and disease status. Coordinates and conducts activities associated with the preparation and shipment of protocol related samples within specified parameters. Prepares, transports, and handles bloodborne pathogens and other human specimens following OSHA guidelines. Enters and maintains both current and new study participant information into the clinical trials database. New patient enrollments and status updates are to be entered into the CTMS within 24 hours of the enrollment or status change. This includes Screening, Screen Failures, Consenting, Enrolling, Active on Treatment, Follow up, and Off study status. New patient enrollments and status updates are to be entered/confirmed in EPIC within 24 hours of the enrollment and or status change. This includes Consented- in screening, Enrolled-Receiving treatment and/or intervention, Enrolled-follow up only, Lost to follow up, Screen failure and Completed. Research participant protocol-related visits must be linked in EPIC prior to the encounter.
20% Assists investigators to identify, consent, screen, register/ enroll eligible patients to studies at Hollings Cancer Center.
Screens all patients at the Hollings Cancer Center (HCC) that have been newly diagnosed, have progressed, or experienced a recurrence to potentially be included into a clinical trial. Attends and actively participates in regularly scheduled multidisciplinary tumor boards, clinics, conferences, and any other forum where patients may be discussed. Documents and tracks all screening efforts per departmental guidelines. Establishes communication with physician investigators and care team regarding potential study participants. Effective screening of HCC patient medical records requires knowledge of oncology terminology, medical terminology, disease specific staging and each clinical trial protocol eligibility criterion. Meets weekly with their clinical operations team to discuss potential trial participants and plan for the upcoming week for all clinic coverage needs. Under guidance of the team lead coordinator(s) and program manager, will support research activities at any of the MUSC main campus and HCC satellite locations and make necessary coverage plans in advance, to avoid interruption of quality CTO services. Participates in and supports the informed consent process per departmental and institutional policy.
20% Timely and accurately collects and submits data to established research bases including the National Cancer Institute, industry sponsors and MUSC.
Ensures data quality and timely completion and submission of case report forms (CRFs) and queries. Develops and implements an effective daily routine which minimally includes retrieval of ongoing data from local or outside medical records, completion of appropriate case report forms and any data query received. Ensures data is submitted according to sponsor mandated time frames and in a manner that affords maximum accuracy. Ensures source documentation is present in patient chart for case report form completion. Visit-specific CRFs are to be completed per sponsor requirements. Case report submission may include patient reported outcome questionnaires, radiologic scans, reports and staging tests. Proactively plan, prioritize and manage responsibilities to ensure timely and accurate data submission to specified research bases. Data submission is timely and accurate per the protocol, patient calendar, and source documents. Collaborates with Data Coordinators as needed with patient protocol visits including adverse event logs, patient questionnaires, picking up specimens, and transporting study supplies. Maintains established workflows to identify data needs of numerous trials within multiple disease groups and communicates data entry needs to study team.
15% Timely and accurately submits Adverse Events, Serious Adverse Events, and other reportable events to the NCI, sponsors, IRB and DSMC per federal guidelines and institutional policies.
Prepares and submits CTO-required and sponsor specific initial and follow up reports. Adheres to the reporting requirements within the Clinical Trials Office, MUSC and various study sponsors. Proactively plans to ensure reports are comprehensive and that reporting requirements are met within the allowable timeframe and in a manner that affords maximum accuracy. Submits regulatory documents upon receipt to the Manager of Regulatory Compliance to ensure timely reporting by the regulatory unit of CTO. This includes Adverse Event reports and protocol deviation reporting as well as any new protocol documents which may include but are not limited to protocol amendments, correspondence from sponsor, or any other documents requiring review and/or submission to IRB. Additional non-regulatory reporting requirements would include submission of screening logs and database updates. Protocol deviations will be reported to the clinical trials office regulatory unit per departmental processes. Items that are outstanding per sponsor monitoring visit letters will be addressed and closed within 4 weeks of receiving the monitoring letter, or by the date of the monitor's next site visit, whichever is earlier.
10% Maintain working knowledge of disease specific trial portfolio and participate in disease focus group meetings to support trial start up process for new studies and maintenance of protocol amendments.
Presents pertinent research related data to the research focus group and individual investigators. Maintains up to date protocol information, communication and education of study and clinic personnel. Assists in planning, implementing, and evaluation of program expansion and new projects. Positively and professionally contributes to working groups and meetings. Initiates and organizes meetings and prepares meeting agendas. Discusses high priority trials. Presents protocols to programs and clearly assesses patient population and feasibility of trial. During the "In Approval Process-Step 1" reviews new protocols, completes the initial roadmap submission by designated timeline and obtains study specific credentialing per protocol requirements. Collaborates with the CTO nurse managers in development of initial roadmap and amended roadmaps as applicable. As protocol amendments are received amended roadmaps are completed by the assigned date to ensure patient safety. Completes the Initial roadmap submission by assigned due date. Roadmap submission forms are comprehensive and include all study assessments required per the protocol and study calendar. Roadmap submission forms are accurate including treatment arms, hold and call parameters and dosing modifications per the protocol guidelines.
Additional Job Description
Minimum Requirements: A bachelor's degree and two years of relevant program experience.
Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent)
If you like working with energetic enthusiastic individuals, you will enjoy your career with us!
The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.
Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: ***************************************
$41k-59k yearly est. 12d ago
Clinical Research Coordinator II
Care Access 4.3
Clinical research coordinator job in Dalton, 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 to 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 clinicalresearch 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 ClinicalResearchCoordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinicalresearch study subjects while ensuring protocol and regulatory compliance.
How You'll Make An Impact
Patient Coordination
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.
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
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.
Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
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.
Assist in the creation and review of source documents.
Patient Recruitment
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
Review and assess protocol (including amendments) for clarity, logistical feasibility
Ensure that all training and study requirements are met prior to trial conduct
Communicate clearly verbally and in writing
Attend Investigator meetings as required
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
The Expertise Required
Ability to understand and follow institutional SOPs.
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 ClinicalResearchCoordinator experience required
Prefer 1 year of experience as a Care Access ResearchClinicalResearchCoordinator
Recent phlebotomy experience required
Licenses:
California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health
Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners
Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health
Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health
How We Work Together
Location: This is an on-site position with regional commute requirements, located in Dalton, Georgia
Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives.
Type of travel required: Regional (within 100 miles)
Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
Walking - 20%
Standing - 20%
Sitting - 20%
Lifting - 20%
Up to 25lbs
Over 25lbs Overhead
Driving - 20%
The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
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: ********************************
$60k-90k yearly Auto-Apply 11d ago
Clinical Research Coordinator (LOCATED In Atlanta)
Actalent
Clinical research coordinator job in Charleston, SC
ClinicalResearchCoordinator (LOCATED in Atlanta, GA) MUST be able to relocate on your own to the Atlanta, GA area (no relocation offered) Manage and coordinate oncology clinicalresearch trials, including patient recruitment, protocol development, and data management.
Oversee oncology trials and research projects
Develop research protocols and grant proposals
Perform patient evaluations and administer medications
Train and supervise staff
Ensure compliance with regulations through audits
Manage financial accounts and authorize purchases
Develop strategies for participant recruitment and retention
Interface with study sponsors and resolve queries
Monitor IRB submissions and respond to requests
Qualifications
MUST be able to relocate on your own to the Atlanta, GA area (no relocation offered)
MUST have ClinicalResearchCoordinator (CRC) experience
3+ years of solid CRC experience in oncology or interventional drug trials in other therapeutic areas
Two years of college in a scientific, health related, or business administration program AND 3 years of clinicalresearch experience
OR
High School Diploma or GED AND3+ years of clinicalresearch experience
Pay and Benefits
The pay range for this position is $28.00 - $30.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
* Medical, dental & vision
* Critical Illness, Accident, and Hospital
* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
* Life Insurance (Voluntary Life & AD&D for the employee and dependents)
* Short and long-term disability
* Health Spending Account (HSA)
* Transportation benefits
* Employee Assistance Program
* Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Charleston,SC.
Application Deadline
This position is anticipated to close on May 2, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
$28-30 hourly 60d+ ago
Clinical Research Coordinator II
Cenexel 4.3
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 clinicalresearch managers with a history of success.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel ClinicalResearch 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 ClinicalResearchCoordinator 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 ClinicalResearch 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.
$45k-65k yearly est. 60d+ ago
Clinical Research Coordinator/DHS II - Calhoun, GA 1.14.26
N-Power Medicine
Clinical research coordinator job in Calhoun, GA
About N-Power Medicine N-Power Medicine aims to establish a new paradigm in drug development by reinventing the ‘how' and transforming clinical trials through better integration with clinical practice, ensuring broader participation by physicians and patients. We are building an exceptional multi-disciplinary team with diverse expertise spanning healthcare, engineering, technology and regulatory, and with people who share our core value of Empowering Community through generosity, curiosity and humility. We are working with urgency to bring better therapies to patients faster.
Position Summary
You will be a part of the rapidly changing clinical oncology environment with the opportunity to impact the future of clinicalresearch and improve patients' lives while growing professionally at a dynamic, fast-growing, start-up organization. As the Digital Health Specialist II (internal title), you will work at a clinical site in Calhoun, GA.
The ideal candidate has clinical oncology research experience or research experience in a healthcare setting. You are confident in your understanding of clinical workflow, patient data systems and clinicalresearch in an oncology setting. We are looking for individuals who are motivated and ambitious professionals who desire to positively influence and innovate upon the quality of care for patients diagnosed with cancer.
Roles and Responsibilities
Serve as the Company's trusted face to the clinical practice, providing clinical support while advancing research data collection.
Interface directly with the healthcare providers and patients.
Perform peer review of clinical documentation for data quality and completeness.
Partner with Senior DHS to address any clinic or team issues and concerns.
Obtain informed consent for N-Power Medicine's clinical trials.
Assist and participate in the site clinical trial initiation and clinical trial(s) activities as assigned.
Ensure adherence to study protocols, data completeness and patient consent.
Assist in patient recruitment strategies where appropriate.
Foster collaborative relationships by effectively communicating with clinical site staff, internal stakeholders, and the N-Power Medicine team by attending site specific meetings.
Build and maintain relationships at the clinical site, becoming part of the functional team of practitioners.
Ensure quality and integrity of data capture, compliance and confidentiality with N-Power Medicine's and site's policies, standard operating procedures (SOPs), and Good Clinical Practice (GCP).
Respond to queries regarding missing, aberrant, or potential outlier data and data verification- escalate to the health care provider as necessary for resolution.
Provide proactive input and user experiences for our software.
Additional duties and responsibilities as required.
Generous, curious and humble.
Qualifications
3+ years of experience in oncology clinicalresearch and/or oncology ambulatory care preferred
Bachelor's degree, focused in health science or related field preferred
Certified ClinicalResearchCoordinator, Associate or Professional (CCRC, CCRA or CCRP) preferred
Knowledge of clinical trials, study-specific operating procedures and patient consent forms
Strong desire to drive a paradigm change in clinicalresearch conduct and improve patients' lives
Compassionate focused patient care
Supports and encourages other team members, contributing to a positive team environment
Self-starter, able to work independently, prioritize actively, seek input, and problem solve in complex and fast-evolving environments
Results oriented focused on delivering the goals set-forth
Attention to detail and strong organizational skills
Excellent oral/written communication and interpersonal skills
Critical thinking and proven problem-solving skills
Work hours are dependent on local Network Partner Clinics (typically M-F, 8-5pm)
Please note that state-specific background checks and screenings may be required for this role. Employment is contingent upon successfully passing all applicable screenings.Travel Requirements
Daily travel between sites may be required
More About UsWe are a mission driven, well -funded, rapidly growing company, eager to attract passionate professionals offering a highly attractive compensation package with a balanced and flexible work environment, competitive industry benefits as well as a 401K plan and other great company “perks.”
We are an Equal Opportunity Employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Covid-19 Policy - The Company is committed to providing and maintaining a safe workplace, and to safeguard the health and well-being of our employees, families, visitors, and the community. While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary. We currently do not have mandatory COVID-19 vaccination requirements for our employees and contractors, as the COVID-19 public health emergency has ended. However, there are certain N-Power Medicine employees and contractors who, based on their role, will be required to continue to follow our 2021 COVID-19 vaccination and other requirements as mandated by N-Power Medicine's partners they serve. We reserve the right to modify or amend our corporate policy at any time.
Applicants must be currently authorized to work in the U.S. on a full-time basis. The Company will not sponsor applicants for work visas.
If you find this opportunity compelling, we encourage you to apply today! We promptly review all applications. Highly qualified candidates will be directly contacted by a team member.
$43k-63k yearly est. Auto-Apply 5d ago
Clinical Research Associate 1
Allen Spolden
Clinical research coordinator job in Boston, GA
Responsible for providing ClinicalResearch 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 clinicalresearch 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 clinicalresearch 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
$52k-81k yearly est. 60d+ ago
Clinical Research Coordinator
No-Resistance Consulting Group
Clinical research coordinator job in Atlanta, GA
:
Headquartered in Birmingham, No Resistance is a clinical trial site management organization that performs clinical trials in urgent care centers throughout the north and southeast. We focus on sample collection and testing trials for lab device manufacturers with the purpose of collecting data to support the device's 510(k) or emergency use approval by the FDA. Notably, the trials we have participated in have directly led to the FDA EUA approval of three separate COVID-19 PCR testing platforms.
No clinical trial experience is required. No Resistance will train the right candidate(s). Hours are Monday-Friday 8:30 am to 5:00 pm with no weekend requirements.
Job Description:
No Resistance is seeking motivated individuals to join our team! In this role, you'll play a pivotal part in the implementation and execution of clinicalresearch projects, ensuring the successful attainment of quality, safety, regulatory, and financial objectives.
Job Duties:
Maintaining regulatory binders, inventory of study-specific and clinical supplies.
Recruiting, and enrolling study subjects.
Obtaining informed consent.
Collecting nasal swab samples.
Testing samples on investigational laboratory PCR analyzers.
Data collection and entry.
Query resolution.
Assuring protocol compliance and efficient workflow including organizing clinical work areas, tracking and ordering study supplies and shipping materials, checking and replacing expired items, etc.
Key Success Factors:
Ability to work independently.
Desire to work in a clinical environment with direct patient contact.
Genuine interest in research.
Timely in all communications.
Superior attention to detail.
While not a requirement, senior pre-medical students who hope to gain experience in clinicalresearch or recent graduates who have a "gap" year before they start medical school are encouraged to apply. This position offers an exceptional opportunity to earn a competitive income while gaining invaluable experience highly regarded by medical school admission committees.
Job Type: Full-time
Pay: $25.00 per hour
Expected hours: 40 per week
Benefits:
401(k)
Dental Insurance
Health Insurance
Paid time off
Vision Insurance
Schedule:
Monday to Friday
Work Location: In person
$25 hourly 10d ago
Clinical Research Coordinator -Traveling PRN
Alcanza Clinical Research
Clinical research coordinator job in North Charleston, SC
Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinicalresearch company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
The ClinicalResearchCoordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.
Key ResponsibilitiesEssential Job Duties: In collaboration with other members of the clinicalresearch site team, works to ensure the execution of assigned studies. Responsibilities may include but are not limited to:
Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines:
Screening of patients for study enrollment;
Patient consents;
Patient follow-up visits;
Documenting in source clinic charts;
Entering data in EDC and answers queries;
Obtaining vital signs and ECGs;
May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;
Requesting and tracking medical record requests;
Updating and maintaining logs, chart filings;
Maintaining & ordering study specific supplies;
Scheduling subjects for study visits and conducts appointment reminders;
Building/updating source as needed;
Conducting monitoring visits and resolves issues as needed in a timely manner;
Ensuring study related reports and patient results are reviewed by investigator in a timely manner;
Filing SAE/Deviation reports to Sponsor and IRB as needed;
Documenting and reporting adverse events;
Reporting non-compliance to appropriate staff in timely manner;
Maintaining positive and effective communication with clients and team members;
Always practicing ALCOAC principles with all documentation;
May assist with study recruitment, patient enrollment, and tracking as needed;
Maintaining confidentiality of patients, customers and company information, and;
Performing all other duties as requested or assigned.
Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.;
Prepare and attend site initiation visits (SIV's) and Investigator Meetings (IMs), as needed;
May set up, train and maintain all technology needed for studies.
Skills, Knowledge and ExpertiseMinimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinicalresearch or clinical experience, OR an equivalent combination of education and experience, is required. Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred. Bi-lingual (English / Spanish) proficiency is a plus. BLS certified/preferred.
Required Skills:
Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm);
Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc
Strong organizational skills and attention to detail.
Well-developed written and verbal communication skills.
Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
Must be professional, respectful of others, self-motivated, and have a strong work ethic.
Must possess a high degree of integrity and dependability.
Ability to work under minimal supervision, identify problems and implement solutions.
Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
Benefits
Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
Dialysis Clinic, Inc. is recruiting top talent interested in supporting our nonprofit mission to prioritize individualized care for patients facing chronic kidney disease. Our mission states “the care of the patient is our reason for existence,” and our dedicated team embodies our sole purpose during every patient interaction. We seek motivated, compassionate individuals to provide top-notch patient care and offer paid training, competitive pay, outstanding benefits, Sundays off and a strong culture. Join DCI today to build relationships and gain fulfillment serving individuals in our comfortable clinical setting with a lower caregiver-to-patient ratio than other providers.
ClinicalResearchCoordinators provide support, coordination and leadership for drug/device studies that may involve industry-sponsored Phase I, II, III, and IV clinical trials; government-funded clinicalresearch, and investigator-initiated clinicalresearch (collectively referred to as “clinicalresearch involving human subjects”). They ensure smooth, accurate progress of clinical studies from the planning and approval stages through study completion and post-study closure. They prepare documentation for submission for review by the Institutional Review Board (IRB), recruit and screen study participants, schedule clinical treatment and follow-up care, and facilitate patient's continued participation; abstract data from medical records and other sources; collect, submit and maintain study data and regulatory documents, and ensure compliance with study protocols in order to provide consistent and quality data. Provide superior healthcare utilizing medical knowledge and clinical skills throughout each clinical trial.
Schedule: Full-time, typical schedule is five 8-hour shifts, Monday - Friday
Compensation: Minimum salary starts at $45K with flexibility regarding starting salary based on experience and education
Benefits:
Comprehensive medical, dental and vision benefits
Life and long-term care insurance provided at no additional expense to employee
Paid time off (PTO) including holidays
Extended Sick Bank (ESB) in addition to PTO - paid time for doctor appointments, sickness or medical leave
Retirement plans with $.50 of each contributed dollar matched for eligible employees, up to 8 percent
Education reimbursement
Employee assistance program
Wellness program
Among others
Responsibilities
What You Can Expect:
Ensure compliance with the clinical trial protocol and overall objectives of the study including the collection, preparation, maintenance, and submission of numerous study documents: Institutional Review Board (IRB) applications, CV's, medical licenses, case report form(s), regulatory documents binder, electronic data capture, etc.) as applicable.
Perform detailed medical chart review and patient interview to ensure patient qualifies to be enrolled in the study.
Manage informed consent process and ensure confidentiality practices are consistent with regulatory and study guidelines.
Meet enrollment goals as directed by DCICR Director.
Maintain a strong relationship with subjects involved in clinical trials and ensure that their rights as subjects are protected.
Coordinate and perform study visits/procedures (vital signs, EKG's, BIA, medical history, lab procedures, etc.) per qualification and per protocol.
Log and inform Principal Investigator (PI) of any possible adverse reactions or serious adverse events in a timely manner.
Maintain study logs, IRB forms and Regulatory Binders for each clinical trial.
Maintain a strong relationship with and be available to investigators and research, dialysis, and practice staff to ensure subject safety and compliance with the clinical trial protocol.
Participate in routine monitoring visits from Sponsor and/or FDA audits.
Conduct clinical trials in 2 or more outpatient dialysis units as needed.
Coordinate multiple trials.
Work flexible hours in order to accommodate study visits and perform job functions as needed.
Travel overnight for Investigator Meetings as required.
Work independently with limited supervision.
Maintain and follow up with all research documentation and data involved in coordinating a clinical trial and/or multiple clinical trials in a timely manner to provide quality data and/or information.
Other responsibilities as defined by DCICR Director and/or DCICR Clinical Manager.
Qualifications
Successful Candidates Bring:
Excellent communication skills
Demonstrated clinical excellence
Desire to collaborate with care teams
Ability to problem solve
Education/Training:
An individual with at least 2 years of experience conducting clinical trials or an individual currently employed in the medical field; dialysis experience preferred.
Reliable transportation, a valid driver's license, auto insurance, and be willing to travel to multiple DCI clinics within a given territory.
DCI is committed to building a diverse and inclusive organization. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status.
DCI's Differentiator:
Since opening the first clinic 50 years ago in Nashville, Tenn., our Dialysis Clinic, Inc. family has grown to be the nation's largest nonprofit dialysis provider with more than 270 locations in 30 states, serving nearly 14,000 patients each day. DCI invests in our care teams and funds research to further kidney care and treatment options. DCI prioritizes a holistic approach and offers hemodialysis, home dialysis and peritoneal dialysis treatment options. We empower patients to live meaningful and productive lives while also delivering high quality kidney care, saving lives and reducing hospitalizations. Learn more about DCI and see if we're hiring in a clinic near you! ***************
DCI is a federal contractor and an Equal Opportunity/Affirmative Action Employer-Veterans/Individuals with Disabilities. If you are having difficulty using the online application system or would like to request other accommodations or application methods, please contact Doug Patterson at Accommodations@dciinc.org or ************. Once a request has been made, DCI will initiate a discussion with you about your needs and whether an accommodation can be provided. DCI is committed to providing such accommodations where possible.
For more information about equal opportunity please see:
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Security Roles and Responsibilities can be reviewed at: *************************************
$45k yearly Auto-Apply 60d+ ago
Learn more about clinical research coordinator jobs
How much does a clinical research coordinator earn in Athens, GA?
The average clinical research coordinator in Athens, GA earns between $36,000 and $75,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.
Average clinical research coordinator salary in Athens, GA