Clinical Research Associate II - Transplant and Transfusion
Clinical research associate job in Norcross, GA
A Clinical Research Associate II (CRA-II) plays a key role in monitoring and ensuring the integrity of clinical studies that evaluate the safety, performance, and effectiveness of medical devices and related products. This position supports the clinical operations function by ensuring compliance with applicable regulatory requirements and study protocols. By safeguarding data quality and patient safety, the CRA-II enables the organization to bring innovative healthcare solutions to market efficiently and ethically. The role adds value by bridging scientific research with operational excellence, ensuring studies are executed on time and to the highest quality standards
Responsibilities
Key Accountabilities
Conduct site qualification, initiation, monitoring, and close-out visits to ensure compliance with study protocols and regulatory requirements.
Serve as the primary point of contact between the sponsor and investigator sites, fostering effective communication and issue resolution.
Verify that investigator sites have adequate resources, qualified staff, and investigational products throughout the study lifecycle.
Ensure adherence to Good Clinical Practice (GCP), company SOPs, and applicable regulatory guidelines for all assigned studies.
Monitor data integrity by reviewing source documents, case report forms, and ensuring accurate and complete trial records.
Identify, document, and communicate protocol deviations, non-compliance, and safety issues promptly.
Assist in managing study timelines, budgets, and deliverables, escalating risks.
Prepare and maintain essential clinical trial documentation, including protocols, agreements, study reports, and site communications.
Assist with reagent inventory management - ordering, storage and dispostion of investigation products and study supplies
Uses the English language effectively in both written and verbal communication to convey complex clinical concepts with clarity and precision.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Networking/Key relationships
Work closely and collaboratively with members of clinical affairs (Clinical Project Leader, Senior CRA,CRA,Statistician)
Interface regularly with crossfunctional teams (R&D,Regulatory) as well as other functions across the organization as needed
Qualifications
Minimum Knowledge & Experience required for the position:
Bachelor's degree in life sciences or related field (Medical Technology, Biology.)
Minimum of 3 years clinical research experience in coordinating or monitoring Medical Device (IVD) Trials or working with a CRO
Strong understanding of GCP guidelines, International Conference on Harmonization (ICH) and regulatory requirements (FDA,IVDR)
Excellent understanding of clinical trial design
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Skills & Capabilities:
Demonstrates strong regulatory knowledge to maintain compliance across global studies.
Executes effective site monitoring and management, ensuring adherence to study protocols and timely issue resolution.
Maintains meticulous attention to detail in documentation, source data verification, and reporting to support high-quality outcomes.
Communicates clearly and professionally with investigators, sponsors, and cross-functional teams to foster collaboration and alignment.
Manages multiple projects and timelines efficiently, prioritizing tasks to meet study milestones and regulatory deadlines.
Adapts quickly to change, responding to evolving protocols, site needs, and regulatory updates with flexibility and composure.
Travel requirements:
Will vary by project. Travel requirement could be approx. 20%
Auto-ApplyResearch Associate - Clinical Trials Office
Clinical research associate 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 clinical research 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 ************.
Clinical Research Associate II
Clinical research associate job in Kinsey, AL
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
Assistant Research Coordinator
Clinical research associate job in Huntsville, AL
We are looking for candidates in Huntsville, AL with a medical background and excellent interpersonal experience to support, facilitate, and organize daily human clinical trial activities. This person will be an integral part of the research team and play a part in the day-to-day running of human trials.
The following are a list of responsibilities:
experience with standard regulatory submissions (including 1572 and IRB)
review and execute trial activities as outlined in the study protocol
direct and participate in protocol training for research staff
obtain informed consent from potential subjects
write SOPs and update source documents as needed
organize subject binders
have a working knowledge of sponsor/FDA audits
GCP certified
previous clinical trial experience
computer skills are essential (incl. Excel, Adobe, Word, etc)
familiar with device skills including study devices, pt devices, iPhones, etc.
act as the liaison between regulatory authorities and the research team
other duties as needed
Personal Characteristics
honest, high integrity a must
highly organized, detail-oriented, meticulous and thorough
life learner
able to handle increased amounts of paperwork
compassionate and caring
able to work independently
self-motivator
**Salary based on experience. Benefits available if needed.
Clinical Research Coordinator - Level 2
Clinical research associate job in Knoxville, TN
CRC Level I - Knoxville, TN (Onsite)
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We have an incredible opportunity for a Clinical Research Coordinator 2 to join ICON's Accellacare team. The CRC 2 ensures the safety of our volunteers, promotes the mission of Accellacare, and strives to meet and exceed study priorities. This individual is responsible for recruiting and promoting our service to suitable participants and sponsor representatives. Additionally, the CRC 2 will autonomously perform tasks required to coordinate and complete multiple studies according to the protocol. They will assist the Manager of Clinical Operations and Senior CRCs with staff development through mentoring and site level quality assurance.
This role is with Accellacare, part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research.
Location: Onsite (1200 Merchant Drive, Knoxville, TN 37912)
What you will be doing:
Performs study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site
Proactively develops and executes recruitment plans that meet and exceed enrollment goals
Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants.
Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.
Attends investigator meetings
Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines
Accurately collects study data via source documents/progress notes as required by the protocol
Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol
Performs continuous reviews of the inclusion and exclusion criteria for each participant during the trial for their trials as well as peer review of inclusion and exclusion for trials
Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events
Builds and maintains strong relationships with Investigators and provides ongoing communication about trial status and participants
Dispenses study medication at the direction of the Investigator
Maintains communication with the monitor from the sponsoring company through telephone contact, written communication and on-site visits
Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor
Your Profile:
2+ years of patient-facing Clinical Research Coordinator experience
Strong attention to detail
Motivated about a career in clinical research
Excellent time management and planning skills with an organized approach to work
Bachelor's degree in life sciences or other related field
#LI-Office
#LI-TP1
#LI-Accellacare
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
Auto-ApplySenior Clinical Research Coordinator/Sr. DHS - Alabama 10.3.25
Clinical research associate job in Alabama
About N-Power MedicineN-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 OverviewYou will be a part of the rapidly changing clinical oncology environment with the opportunity to impact the future of clinical research and improve patients' lives while growing professionally at a dynamic, fast-growing, start-up organization. As the Senior Digital Health Specialist, you will work at a clinical site in Tuscaloosa and/or Anniston, Alabama. This role would act as a site liaison between NPM staff and the network partner to address any issues or concerns in real time.
The ideal candidate has extensive clinical oncology research experience or research experience in a healthcare setting. You are an expert in your understanding of clinical workflow, patient data systems and clinical research in an oncology setting. In collaboration with the Digital Health Specialist Manager, you will be vital to the successful implementation and operations with Network Partners and serve as point of contact for local N-Power Medicine staff. 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.
Role Objectives and Responsibilities
-Serve as the Company's trusted face to the clinical practice, providing clinical support while advancing research data collection.-Act as the point of contact for network partners and N-Power Medicine staff supporting the site to address queries and issues in a timely manner.-Participate directly in the implementation at the site and all aspects of a site start-up. -Support the hiring and onboarding of new N-Power Medicine staff including, new hire interviews, new hire training, onsite shadowing, etc.-Perform quality assurance activities as required, identify opportunities for retraining of Digital Health Staff.-Assist in developing training, work instructions and standard operating procedures, and other materials.-Manage queries regarding missing, aberrant, or potential outlier data for studies and projects - escalate to the healthcare provider and Digital Health staff as necessary for resolution.-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.-Lead patient recruitment strategies where appropriate as site liaison and network partner research department. -Foster collaborative relationships by effectively communicating with clinical site staff, internal stakeholders, and N-Power Medicine.-Attend, participate and take action in required meetings.-Build and maintain relationships at the clinical site, becoming part of the functional team of practitioners.-Ensure quality and integrity of the Kaleido Registry and clinical trials data, protocol compliance and confidentiality with N-Power Medicine's and site's policies, standard operating procedures (SOPs), and Good Clinical Practice (GCP).-Collect practice insights regarding Kaleido Registry workflows and maintain site performance metrics for internal and site reporting. -Provide proactive input and user experiences including software- escalate issues while offering solutions based upon your expert knowledge and experience. -Solicit feedback from users of new technology and contribute to implementation for clinical care and clinical trials. -Additional duties and responsibilities as required.
Education, Experience, Behavioral Competencies, & Skills-5+ years of experience in oncology clinical research and/or oncology ambulatory care -Bachelor's degree, focused in health science or related field -Clinical supervisory or management experience preferred-Certified Clinical Research Coordinator, Associate or Professional (CCRC, CCRA or CCRP) preferred-Bilingual in Spanish (or other language) is preferred-In depth knowledge of clinical trials, study-specific operating procedures and patient consent forms-Strong desire to drive a paradigm change in clinical research conduct and improve patients' lives-Compassionate focused patient care-Coach 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-Exceptional oral and written communication skills with a proven ability to lead through effective interpersonal interactions at all organizational levels-Critical thinking and proven problem-solving skills-Work hours are dependent on local Network Partner Clinics (typically M-F, 8-5pm)-Generous, curious and humble.
Travel Requirements Daily travel between network partner sites may be required
Pay InformationThe expected salary range for this position is $118,000 and $177,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. N-Power Medicine (NPM) offers equity at hire as well as a discretionary annual bonus which may be available based on Company performance. This position is eligible for company benefits.
More About Us:We 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 based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
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.
Please note that state-specific background checks and screenings may be required for this role. Employment is contingent upon successfully passing all applicable screenings.
Notice on fraudulent job offers: Only positions posted on ****************************************** site are legitimate. Please be mindful of recruitment fraud and job scams. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Auto-ApplyStudy Coordinator, Manager
Clinical research associate job in Birmingham, AL
Job Description
Manager, Study Coordination & Quality Control
Join a team driven by science, powered by people, and committed to improving lives.
A GLP public CRO is seeking an experienced and passionate Manager, Study Coordination & Quality Control, to lead its Preclinical Operations team. In this critical leadership role, you will oversee project execution, ensure quality excellence, and mentor a talented group of Study Coordinators and Quality Control Specialists. If you thrive in a collaborative, fast-paced environment and have a strong commitment to scientific rigor and operational precision, we'd love to meet you.
About the Role
As the Manager of Study Coordination & QC, you will guide day-to-day operations, champion quality excellence, and empower your team to deliver project outcomes that are on time, within budget, and compliant with all standards. Working closely with Study Directors, Project Managers, and other internal partners, you'll ensure seamless planning, execution, and reporting across preclinical studies.
You will play an instrumental role in optimizing workflows, monitoring financial impact, enhancing cross-functional processes, and elevating the quality of deliverables. This is an opportunity to create meaningful impact-from shaping departmental procedures to supporting studies that advance scientific innovation.
Key Responsibilities
Team Leadership & Development
Lead, mentor, and develop a high-performing team of Study Coordinators and QC staff.
Provide daily work direction, coaching, performance feedback, and career development.
Foster a diverse, collaborative, and trust-centered team environment.
Operational Execution
Oversee study coordination activities from project initiation through reporting.
Collaborate with Project Managers, Study Directors, and internal stakeholders to support costing, scheduling, tracking, and reporting.
Ensure all work is completed accurately, on time, and within budget.
Maintain operational calendars and oversee Provantis data collection software usage and data extraction.
Quality Oversight
Monitor end-to-end process quality; develop and track quality metrics across operations.
Review protocols, amendments, and reports for accuracy and compliance.
Participate in pre-study and post-project evaluations, identifying opportunities for improvement.
Strategic & Administrative Contributions
Participate in departmental budgeting and workload projections.
Identify staffing needs; support recruitment, hiring, and performance management.
Develop and maintain SOPs to ensure alignment with current practices.
Promote safety standards and uphold strong business ethics.
Qualifications
Bachelor's degree required.
Minimum 5 years of study coordination and QC experience in a preclinical or related scientific environment.
Ability to meet medical and safety requirements (including required vaccinations).
Proven leadership skills, strong communication abilities, and a commitment to operational excellence.
What We Value
Our core values shape how we work and how we lead:
Cultivating Human Connection
We put people first and believe in the power of trust, inclusion, and courageous teamwork.
Operating with Precise Execution
We leverage data, remain agile, take ownership of results, and treat feedback as an opportunity to grow.
Harnessing Relentless Curiosity
We ask sharp questions, push scientific boundaries, and continuously innovate.
Stewarding a Healthy Community
We prioritize safety, sustainability, dignity, and equitable opportunities for employees, customers, and communities alike.
Behavioral & Leadership Expectations
Build and maintain a high-trust, high-performance team.
Communicate clearly and with impact across diverse audiences.
Coach and develop others, recognizing achievements and addressing challenges promptly.
Plan effectively, stay organized, and consistently deliver operational excellence.
Work Environment
This role includes work in both office and laboratory settings and requires the use of PPE, completion of medical evaluations, and the ability to receive experimental vaccines as required.
Ready to Make an Impact?
If you are driven by purpose, inspired by scientific progress, and energized by leading teams toward excellence, we encourage you to apply.
Clinical Research Study Assistant II - Psychiatry
Clinical research associate job in Forest Park, GA
Scheduled Hours40The Cruchaga Lab, the NeuroGenomics and Informatics (NGI) Center, at WashU Medicine is recruiting a Clinical Research Study Assistant. We are seeking an experienced, self-motivated, self-driven person to work as a part of vibrant group in a fast-paced environment. This person will work in a collegial environment and join a multidisciplinary, diverse team in a well-established, well-funded research group, currently 30+ dynamic members, to explore the frontiers of neurodegenerative diseases. The NGI generates and analyzes Whole-Genome and high-throughput multi-dimensional omics data to study neurodegenerative diseases of the central nervous system. The goal of our research is to use genomic and multi-omic approaches to understand the biology neurodegenerative diseases.
Under the direction of the Research Coordinators or PI, they will participate in moderately complex clinical research study activities. The Clinical Research Study Assistant will be responsible for multiple study's biospecimens including, but not limited to: blood, plasma, serum, and brain. They will perform a variety of duties including the oversight, organization and handling of these biospecimen samples for these multiple studies. They will ship samples and be responsible for an accurate manifest. They will be trained on the lab's database system to maintain the order of the samples. They will be responsible for assembling outgoing biospecimen kits for multiple studies. As needed, they will draw blood from research participants at our various clinics. They will work with the research coordinators for any other responsibilities that may be needed.Job Description
Primary Duties & Responsibilities:
Assists clinical research coordinators with management of clinical trials, by creating outgoing biospecimen kits for blood collection and recording data appropriately.
Assists clinical research coordinators by receiving biospecimen samples from off-campus clinics, evaluating condition of samples, entering into the database, and reporting any issues to the coordinators.
Assists with study sample tracking of home locations and shipping outgoing samples, as needed.
Assists with general supply/equipment orders, material shipments to collaborators, maintenance and cleaning.
Complies with established safety procedures and maintains required documentation on laboratory and specimen conditions.
Working knowledge of computer programs and systems such as Excel and Word, as well as Filemaker Pro and/or Freezerworks.
Assists current phlebotomists with blood drawing duties as needed.
Assists with other duties as assigned by research team.
The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.Required Qualifications
Education:
High school diploma or equivalent high school certification or combination of education and/or experience.
Certifications/Professional Licenses:
The list below may include all acceptable certifications, professional licenses and issuers. More than one credential, certification or professional license may be required depending on the role.Basic Life Support - American Heart Association, Basic Life Support - American Red Cross
Work Experience:
Administrative Or Research (2 Years)
Skills:
Not Applicable
Driver's License:
A driver's license is not required for this position.More About This Job
For more information about the NeuroGenomics and Informatics Center, please visit our website at this link.
Required Qualifications:
Basic Life Support certification must be obtained within one month of hire date
Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements).
Preferred Qualifications
Education:
Associate degree
Certifications/Professional Licenses:
No additional certification/professional licenses unless stated elsewhere in the job posting.
Work Experience:
Customer Service (1 Year)
Skills:
Clinical Trials, Data Entry, Data Management, FileMaker Pro, Freezerworks (Software), Interpersonal Communication, Oral Communications, Ordering Supplies, Organizing, Safety Protocols, Sample Collection, Written CommunicationGradeC07-HSalary Range$19.21 - $28.85 / HourlyThe salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.Questions
For frequently asked questions about the application process, please refer to our External Applicant FAQ.
Accommodation
If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request.
All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.Pre-Employment ScreeningAll external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.Benefits Statement
Personal
Up to 22 days of vacation, 10 recognized holidays, and sick time.
Competitive health insurance packages with priority appointments and lower copays/coinsurance.
Take advantage of our free Metro transit U-Pass for eligible employees.
WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.
Wellness
Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
Family
We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered.
WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.
For policies, detailed benefits, and eligibility, please visit: ******************************
EEO StatementWashington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.
Auto-ApplyClinical Research Coordinator II
Clinical research associate 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 into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference
The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
How You'll Make An Impact
* 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 Clinical Research Coordinator experience required
* Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator
* 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: ********************************
Primary Health Clinical Research Study Operations Coordinator
Clinical research associate job in Centreville, AL
Research Coordinator
Reports to: Chief Medical Officer
We are seeking a detail-oriented, highly organized Research Coordinator with broad medical knowledge to support and manage clinical research activities. The ideal candidate will play a pivotal role in the planning, implementation, and coordination of research studies. This position requires strong analytical skills, a working knowledge of medical terminology, and the ability to interact effectively with investigators, sponsors, and study participants.
Key Responsibilities:
Coordinate and oversee day-to-day operations of multiple research studies in compliance with study protocols and regulatory requirements.
Screen, recruit, and consent study participants; ensure proper documentation and eligibility assessment.
Meet with site managers and providers to explain study eligibility
Collect, process, and manage clinical and research data accurately and in a timely manner.
Maintain and organize essential regulatory documents, case report forms, and study files.
Monitor study progress, perform regular audits, and ensure data integrity and protocol compliance.
Act as a liaison between investigators and research staff.
Coordinate study visits, procedures, and follow-up schedules for participants.
Assist with writing reports, abstracts, and manuscripts for publication or presentation.
Train new staff or students in research procedures and compliance standards.
Qualifications:
Required:
Travel to Cahaba's rural clinics in Perry, Wilcox counties is required
Based in-person in Centreville
Broad Clinical knowledge required
Ability to manage multiple priorities in a fast-paced environment.
Strong organizational, interpersonal, and communication skills.
Demonstrates a high level of initiative and independence in daily tasks
Cahaba Medical Care is an Equal Opportunity Employer.
Auto-ApplyOffice Coordinator- Dr. Chimakurthy, Full Time, Days
Clinical research associate job in Decatur, AL
Coordinates activities of the front office for scheduling patient office visits, procedures and tests with proficiency and compliance. Inputs patient demographic and insurance information to insure successful processing and payment of claims. Provides secretarial support for physicians and administrative staff.
Demonstrates through behavior Decatur Morgan Hospital's mission, vision and values
Responsibilities Key Responsibilities / Essential Functions
Greets patients and visitors in a prompt, courteous, and helpful manner. Communicates effectively with patients and/or family members to obtain needed patient information. Responsible for excellence in customer service and ensuring patient needs are met.
Responds to routine requests for information/service and directs visitors/patients to appropriate medical staff.
Adheres to office scheduling policies and makes and cancels appointments including but not limited to office visits, tests, and procedures through the office scheduling system and hospital system. Obtain pre-certification and/or referrals for patient appointments when necessary.
Adheres to office scheduling policies and makes and cancels appointments including but not limited to office visits, tests, and procedures through the office scheduling system and hospital system. Obtain pre-certification and/or referrals for patient appointments when necessary.
Enters and updates patient information in the computer system to include place of service, insurance type, policy holder, provider of service and referring physician.
Answers telephone in a timely manner, screens calls, takes messages, consults, and provides information.
Checks out patients, collects co-pays and payments on account balances and completes end of day deposit according to policy.
Manages and maintains physician and clinic schedules appropriately. Updates office schedule regularly for patient additions/cancellations.
Completes assigned responsibilities in an appropriate time frame.
Demonstrates flexibility when involved in changing situations.
Demonstrates professionalism in appearance and actions.
Attends required meetings. Participates in staff development and education activities.
Maintains work area and lobby in neat and orderly manner.
Maintains patient confidentiality.
Creates referrals in the scheduling system in a timely manner.
Qualifications Minimum Knowledge, Skills, Experience Required
Education: High school graduate or GED.
Experience: Prefer one year work experience in a medical office setting. Knowledge of medical terminology desirable. Word processing and computer experience desirable.
Additional Skills/Abilities: Knowledge of grammar, spelling, and punctuation to type patient information. Skill in operating a computer, facsimile machine, and photocopy machine. Skill in greeting patients and answering the telephone in a pleasant and helpful manner. Ability to speak clearly and concisely. Ability to read, understand, and follow oral and written instruction. Ability to sort and file materials correctly by alphabetic or numeric systems. Ability to establish and maintain effective working relationships with patients, employees, and the public.
Auto-ApplyClinical Response Coordinator - Legacy of Hope - Huntsville
Clinical research associate job in Huntsville, AL
Schedule: Shifts Can Vary Benefits include: 100% tuition assistance, wellness initiatives, generous paid time off, paid parental leave, Public Service Loan Forgiveness Program eligible employer, plus more. In addition to our many benefits and perks, UAB Medicine provides a variety of resources to support employees both personally and professionally.
The Clinical Response Coordinator (CRC) is an integral role within the organ donation process at Legacy of Hope (LoH). The CRC will be responsible for performing on-site visits to donor hospitals within their coverage area. They, in conjunction with the administrator on call, will determine initial suitability of potential organ and tissue donors. This will be done by communicating and interacting with hospital and physician staff in collaborative and professional ways. The CRC will evaluate specific case dynamics and determine which information is clinically significant and should be communicated to the hospital teams and Legacy of Hope staff who are off-site. They will also assess available clinical data found in medical record or bedside assessment to determine initial medical suitability for donation. The CRC will encourage implementation of catastrophic brain injury guidelines as appropriate based upon their clinical judgement. In situations when needed, the CRC will also be expected to identify and support the needs of the potential donor family and offer them information about donation opportunities (organ and tissue). After authorization is obtained, the CRC will coordinate the transport of blood for serological testing and tissue typing to the appropriate laboratories. They will also initiate individualized case donor management, after brain death is declared, to ensure donor stability while coordinating arrival of procurement transplant coordinator (PTC) or critical care transport (CCT) to donor's location. Donor management could include ordering and interpreting labs, ensuring appropriate fluid maintenance, and implementing vasoactive and hemodynamic supportive medications as required by the donor's status. They will obtain required information from the hospital medical record to be transferred with patients from the donor hospital location to the donor recovery center as appropriate.
The Clinical Response Coordinator will also be able to perform specific partner services activities as directed by their supervisor. Those responsibilities may include but not be limited to: rounding through units to build relationships, presenting information/outcomes to hospital staff members in both formal and informal settings, and participating in education about donor suitability, brain death testing, specific donation processes, etc. This position requires 12-15 days of 24-hour call per month.
Position Requirements:
EDUCATION AND EXPERIENCE:
Required: Associate's degree in a medical or related field and one (1) year of experience in nursing, as an EMT, Paramedic, Respiratory Therapist, Social Worker, or experience in the donation industry required. Work experience may substitute for education requirement.
Preferred: Hospital experience, crisis intervention, and/or grief support.
.
LICENSE, CERTIFICATION AND/OR REGISTRATION:
Required: Valid driver's license and ability to be insured.
Preferred: Currently licensed/certified as a Nurse, Emergency Medical Technician (EMT), Paramedic, Respiratory Therapist, Social Worker, or related.
TRAITS & SKILLS
Must be self-directed / self-motivated; must have good communication and interpersonal skills. Must be able to: (1) perform a variety of duties often changing from one task to another of a different nature without loss of efficiency or composure; (2) accept responsibility for the direction, control and planning of an one's own work; (3) work independently and on a flexible schedule; (4) recognize the rights and responsibilities of patient confidentiality; (5) convey empathy and compassion to those experiencing pain, physical or emotional distress and/or grief; (6) relate to others in a manner which creates a sense of teamwork and cooperation; (7) communicate effectively with people from every socioeconomic, cultural and educational background; (8) exhibit flexibility and cope effectively in an ever-changing, fast-paced healthcare environment; (9) perform effectively when confronted with emergency, critical, unusual or dangerous situations; (10) demonstrate the quality work ethic of doing the right thing the right way; and (11) maintain a customer focus and strive to satisfy the customer's perceived needs.
UA Health Services Foundation (UAHSF) is proud to be an AA/EOE/M/F/Vet/Disabled employer.
Clinical Research Coordinator - PRN/ Contractor
Clinical research associate job in Sandy Springs, GA
M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.
Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.
Due to our continued growth, we are hiring for a contract
Clinical Research Coordinator
at
Wake Research,
an M3 company. This is an on-site position.
A Clinical Research Coordinator (contract/PRN) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial.
Essential services to be performed:
Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses.
Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management.
Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures.
Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria.
Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials.
Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc.
In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed.
Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents.
Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review.
Assists with timely completion of case report forms, if appropriately delegated/trained.
Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability.
Assists fellow co-workers with studies as time and ability permits.
Qualifications
Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
Successful completion of the GCP certification.
Phlebotomy and EKG experience.
+2 years of CRC experience is preferred.
Additional Information
About M3:
M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.
Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.
Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.
Benefits:
A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:
401(k), 401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance
*M3 reserves the right to change this job description to meet the business needs of the organization
#LI-Onsite
#LI-LB1
Clinical Research Coordinator - PRN/ Contractor
Clinical research associate job in Gay, GA
M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.
Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.
Due to our continued growth, we are hiring for a contract Clinical Research Coordinator at Wake Research, an M3 company. This is an on-site position.
A Clinical Research Coordinator (contract/PRN) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial.
Essential services to be performed:
* Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses.
* Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management.
* Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures.
* Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria.
* Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials.
* Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc.
* In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed.
* Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents.
* Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review.
* Assists with timely completion of case report forms, if appropriately delegated/trained.
* Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability.
* Assists fellow co-workers with studies as time and ability permits.
Qualifications
* Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
* Successful completion of the GCP certification.
* Phlebotomy and EKG experience.
* +2 years of CRC experience is preferred.
Additional Information
About M3:
M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.
Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.
Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.
Benefits:
A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:
* 401(k), 401(k) matching
* Dental insurance
* Disability insurance
* Employee assistance program
* Flexible spending account
* Health insurance
* Life insurance
* Paid time off
* Vision insurance
* M3 reserves the right to change this job description to meet the business needs of the organization
#LI-Onsite
#LI-LB1
Clinical Research Coordinator - PRN/ Contractor
Clinical research associate job in Sandy Springs, GA
M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.
Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.
Due to our continued growth, we are hiring for a contract Clinical Research Coordinator at Wake Research, an M3 company. This is an on-site position.
A Clinical Research Coordinator (contract/PRN) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial.
Essential services to be performed:
Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses.
Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management.
Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures.
Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria.
Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials.
Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc.
In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed.
Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents.
Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review.
Assists with timely completion of case report forms, if appropriately delegated/trained.
Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability.
Assists fellow co-workers with studies as time and ability permits.
Qualifications
Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
Successful completion of the GCP certification.
Phlebotomy and EKG experience.
+2 years of CRC experience is preferred.
Additional Information
About M3:
M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.
Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.
Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.
Benefits:
A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:
401(k), 401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance
*M3 reserves the right to change this job description to meet the business needs of the organization
#LI-Onsite
#LI-LB1
Clinical Research Coordinator II
Clinical research associate job in Homewood, AL
Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator II. The ideal candidate will possess 3+ years of clinical research coordination experience, and have a strong desire to work directly with patients.
Who We Are
ObjectiveHealth is a clinical research company that uses proprietary technology to:
* Increase patient access to research trials within our communities,
* Provide physicians with enhanced care options for current patients, and
* Deliver superior clinical research enrollment metrics to Pharma sponsors
All with the goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that.
Who You Are
* A lover of patient interaction and skilled at providing patient care
* A team player with a bias for action and an attitude that takes personal responsibility
* Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc.
* Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc.
* Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence
* An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others
* A strong advocate for Company values, mission, and initiatives
* Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies
* Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Dermatology, and/or Oncology
What Success Looks Like for This Role
* Taking ownership of assigned studies and patients
* Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction
* Showing up on time, every time
* Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies
* Learning and using the technologies we provide to increase efficiency in your day-to-day activities
* Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication
What We Offer
Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits.
Requirements
This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.
Clinical Scheduler, Dr. Anne Rossell, OB, Downtown Nashville
Clinical research associate job in Nashville, TN
Job Details 222 22ND AVE NORTH - NASHVILLE, TN Full Time (32-40 Weekly Hours) Not Specified None Day Health CareDescription
SUMMARY: The Clinical Scheduler is responsible for effectively and professionally managing patient flow from arrival to departure; performing various clerical duties; deals with other clinic personnel, patients and visitors, and fellow employees to ensure good internal and public relations. Handles incoming calls, schedules appointments, returns calls from patients, calls in prescriptions/changes as well as other phone responsibilities. Other duties may be assigned.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Answer incoming telephone calls; handle patient concerns as appropriate or route to appropriate personnel.
Schedule appointments according to doctor's instructions and/or template in the Patient/Practice Management (Scheduling) system.
Review and scan all lab results, correspondence and necessary documents in the patient record.
Handle incoming calls-take complete and accurate phone messages including caller's name, telephone number. For sick calls include signs and symptoms, drug allergies, present medications, and pharmacy phone number. Prescription refills need to include the name of drug, dosage, frequency, and pharmacy phone number. Document appropriately in the EMR system.
Return patient calls in a timely manner
Call in prescriptions/changes according to the doctor's instruction (doctor's order). Document appropriately in the EMR system.
Check for accuracy of insurance status, eligibility, account information, and all vital statistics.
Complete referrals and pre-certifications in a timely manner-should have a good understanding of all insurance companies and referral/ pre-certifications requirements.
Must have predictable and consistent attendance
SECONDARY DUTIES
Open mail daily.
Maintain a clean and orderly work area.
Check for accuracy of insurance status, eligibility, account information, and all vital statistics.
SUPERVISORY RESPONSIBILITIES
This job has no supervisory responsibilities.
Qualifications
Ability to cope with busy, challenging office environment.
Strong phone skills
Pleasant, courteous personality
Basic typing and computer skills, (Patient/Practice Management (Scheduling) & Electronic Med. Records experience helpful) minimum 25 wpm typing
Ability to communicate effectively both written and verbally.
Minimum of two years' experience in a physician's office.
EDUCATION and/or EXPERIENCE
High school education or equivalent.
3-5 years' experience office environment in the medical field.
KNOWLEDGE, SKILLS AND ABILITIES
Skill in establishing and maintaining effective working relationships with patients, medical staff, and the public. Ability to maintain quality control standards. Ability to recognize problems and recommend solutions. Ability to interpret, adapt and apply guidelines and procedures. Finally, articulate speech and pleasant, professional manner are necessary.
CERTIFICATES, LICENSES, REGISTRATIONS
Healthcare Provider BLS Certification
PHYSICAL DEMANDS AND WORK ENVIRONMENT
Must be able to stand/sit for 8 to 10 hours a day
Requires regular walking, bending, pushing, pulling and lifting
Must be able to lift at least 10-15lbs
Must be able to assist patients with transfers from chair to wheelchair, to exam tables, and back to wheelchair/chair
Must be able to assist patient with turning/positioning on exam table
Must be able to push patient in wheelchair
Must be able to manipulate objects-reaching, grasping, handling
Must exhibit good communication skills-understand, respond and translate into action
Clinical setting; exposure to communicable diseases, medical preparations and other conditions common to a clinical environment.
Clinical Research Assistant
Clinical research associate job in Jackson, TN
Clinical Research Assistant-Cardiology Location: Jackson, TN, 38305 Skills:
Support enrolling patients into clinical trials through recruitment, screening, enrollment and follow up of eligible participants, according to protocol requirements.
Conduct patient visits and perform data entry, phlebotomy, and processing of lab specimens.
Minimum 2 years of medical, lab, or clinical experience required.
Knowledge of medical terminology and intermediate computer skills required.
Experience in cardiology strongly preferred.
State licensed LPN or RN preferred.
Must be detail oriented and have excellent organizational and communication skills.
Research Assistant - Clinical Research
Clinical research associate job in Savannah, GA
About Us:
Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Job Summary:
Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies.
Compensation: $20-21/h
Essential Responsibilities and Duties:
Creating and maintaining patient charts for all assigned studies.
Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate. Filing of lab results, EKG results, and other communication in designated patient charts.
Maintaining inventory of study specific supplies including lab kits, assessments and participant facing materials.
Timely completion of data entry and query resolution for all CRFs, based on sponsor specific timelines and deadlines established in contract or other communication.
Assisting Coordinators in assessments, including but not limited to, blood pressure, urine collection.
Communicating with study participants, caregivers, third party vendors and laboratories as needed.
Assisting Coordinators with scheduling, copying, faxing, and other clerical tasks.
Aiding Coordinators in the facilitation of study monitoring visits.
Completion of daily responsibilities delegated by CRC as they pertain to the study and/or participants.
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:
Interest in and knowledge of specific study indications.
Excellent computer skills and advanced knowledge of electronic equipment (i.e., e-mail, computer, fax machine, copier, etc.).
Skilled in organization and record maintenance.
Phlebotomy experience preferred.
Experience working with patients.
Skilled in developing and maintaining effective working relationships with supervisors and co- workers.
Strong personal initiative and attention to detail.
Ability to react calmly and effectively in emergency situations.
Ability to interpret, adapt and apply guidelines and procedures.
Ability to clearly communicate both orally and verbally.
Working Conditions
Indoor, Office environment.
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.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
Clinical Research Assistant / Medical Assistant
Clinical research associate job in Decatur, GA
Department: Operations Employment Type: Full Time Reporting To: Adrienne Hilliard Description Alcanza is a growing multi-site, multi-phase clinical research 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 Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site.
Key Responsibilities
Essential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to:
* Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol:
* Assists with the basic screening of patients for study enrollment;
* Assists with patient follow-up visits;
* Documents in source clinic charts;
* Enters data in EDC and answers queries;
* Obtains vital signs and ECGs;
* May perform blood draws;
* 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;
* Request and track medical record requests;
* Enters data in EDC and answers queries;
* Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and
* Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed;
* Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner.
* Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed;
* Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and
* Perform all other duties as requested or assigned.
Skills, Knowledge and Expertise
Minimum Qualifications: A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is preferred. Bi-lingual (English / Spanish) proficiency is a plus.
Required Skills:
* Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm).
* Must possess 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.