Clinical research coordinator jobs in Mississippi - 49 jobs
Clinical Scientist
Eliassen Group 4.7
Clinical research coordinator job in Jackson, MS
**Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs
**Description:**
_Remote_
Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation.
_This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._
Salary: $130,000 - $150,000/ yr. w2
**Responsibilities:**
**Responsibilities**
+ Lead development of clinical study protocols, case report forms, and associated study documents.
+ Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee.
+ Contribute scientific input into study design, endpoints, and overall clinical strategy.
+ Review and interpret clinical data to support study reports, publications, and regulatory submissions.
+ Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams.
+ Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews.
+ Ensure scientific consistency across programs and alignment with regulatory and clinical goals.
+ Support the development of data collection tools and ensure clarity, accuracy, and completeness.
+ Assist with medical writing elements related to clinical reports and study documentation.
**Experience Requirements:**
**Experience Requirements**
+ Electrophysiology and Pulse Field Ablation experience required.
+ Background supporting clinical studies in industry or academia.
+ Strong understanding of clinicalresearch methods and safety reporting.
+ Ability to evaluate and interpret clinical data.
+ Strong scientific writing skills and attention to detail.
+ Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions.
+ Excellent communication and analytical capabilities.
+ Prior experience as a Clinical Scientist in medical devices preferred.
+ Experience with Class III devices or IDE studies preferred.
+ Experience contributing to regulatory submissions or interacting with health authorities preferred.
+ Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred.
**Education Requirements:**
**Education Requirements**
+ MS, PhD, or MD.
**_Recruitment Transparency Notice_**
**_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._**
_Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._
_W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._
_Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._
_About Eliassen Group:_
_Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._
_Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._
_Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_
$130k-150k yearly 2d ago
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CLINICAL RESEARCH DATA COORDINATOR III (PART-TIME)
University of Alabama at Birmingham 3.7
Clinical research coordinator job in University, MS
The University of Alabama at Birmingham (UAB), Ped - Hematology/Oncology, is seeking a ClinicalResearch Data Coordinator III (Part-Time). General Responsibilities * To design, implement, and maintain clinical-based relational database management systems and tools.
* To develop methods for tracking and reporting data and monitors incoming and outgoing data to ensure data integrity and compliance with applicable regulatory agency standards.
* To perform a variety of statistical analyses and summarizes results.
* To manage clinical data warehouse systems and reporting to national data marts to ensure accuracy, security, and compliance.
Key Duties & Responsibilities
* Verifies compliance with each enrollment and tracks patient compliance throughout the entire duration of the study.
* Develops methods to track and report data.
* Conducts quality assurance activities. May compile and analyze data.
* Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.
* Enters data into REDCap and eDES systems.
* Completes Case Report Forms (CRF) according to protocol.
* Documents Adverse Events (AEs) and Serious Adverse Events (SAEs) as required by protocol and regulatory guidance.
* Collaborates effectively with principal investigators, clinical staff, and research teams to facilitate study operations and protocol adherence.
* Contributes to team meetings, process improvements, and disseminates research findings through manuscript and presentation support.
* Attends study, departmental, and institutional trainings and meetings as required.
* Serves as liaison between UAB staff and other stakeholders.
* Performs other duties as assigned.
Hourly Range: $26.55 - 43.10
Bachelor's degree in a related field and five (5) years of related experience required. Work experience may NOT substitute for education requirement. Certified ClinicalResearchCoordinator (CCRC) or Certified ClinicalResearch Professional (CCRP) certification preferred.
UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.
$26.6-43.1 hourly 4d ago
Sr. Clinical Research Associate - Oncology - FSP
Parexel 4.5
Clinical research coordinator job in Jackson, MS
The Senior ClinicalResearch Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.
**Monitoring Responsibilities and Study Conduct:**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk:**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals
+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Skills:**
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Monitoring Experience: Minimum 3 years relevant experience in clinicalresearch site monitoring (preferably 2 years in Oncology)
+ Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Ability to travel 60-80%
+ Valid driver's license and passport required
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
\#LI-LO1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$84k-110k yearly est. 38d ago
Director of Clinical Research - Administration
Hattiesburg Clinic 4.2
Clinical research coordinator job in Hattiesburg, MS
The Director of ClinicalResearch is responsible for providing strategic, financial, and operational oversight of all clinicalresearch activities within the organization. This position serves as the central liaison among physicians, researchcoordinators, legal counsel, external research sponsors, and financial teams to ensure that all research operations are compliant, financially sound, and aligned with institutional goals. This role requires a unique combination of clinicalresearch knowledge, CPA-level financial expertise, and contract negotiation experience to manage the full research lifecycle-from feasibility review and budget negotiation through billing compliance, payment tracking, and revenue reporting.
EDUCATION & EXPERIENCE:
Bachelor's degree in Accounting, Finance, Business Administration, or a related field, required
Active Certified Public Accountant (CPA) license, preferred
Master's degree in Healthcare Administration, Business, or related field, preferred
Minimum of seven to ten (7 -10) years of experience in financial management, preferably in a healthcare or research setting
Minimum of five (5) years of experience in clinicalresearch operations, contract negotiation, or grants management
Strong understanding of clinicalresearch billing, compliance, and regulatory frameworks
Experience negotiating contracts and budgets with pharmaceutical companies and CROs
QUALIFICATIONS:
Ability to maintain strict confidentiality and handle sensitive information with discretion
Advanced analytical and accounting skills, including proficiency with financial modeling and reporting systems
Strong understanding of the financial workflow of clinical trials, including startup, invoicing, and closeout processes
Exceptional communication and negotiation skills, with the ability to collaborate across multidisciplinary teams
Highly organized, detail-oriented, and able to manage multiple complex projects simultaneously
Proficiency in Microsoft Excel, accounting software, and clinicalresearch management platforms
WORK SCHEDULE:
Monday - Friday, 8:00AM - 5:00PM
$72k-96k yearly est. 6d ago
Clinical Territory Associate - Future Opportunity
Intuitive Surgical 4.9
Clinical research coordinator job in Jackson, MS
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
* Please note: Candidates must live within or be willing to relocate to the Jackson to perform the duties of this role.
Primary Function of Position:
The Clinical Territory Associate (CTA) is a 24+ month developmental role that will partner with the Jackson team to gain knowledge in all aspects of our business to include technical, clinical, and sales.
Responsibilities:
* Assists sales representatives with surgeon trainings, hospitals robotic development, and overall territory management
* Guides technical in-services for customers to include OR staff, surgeons, etc.
* Sells benefits of advanced technology to existing robotic users to contribute to team overall quotas
* Gains experience in goal setting, mapping, and attaining in preparation for quota bearing role to follow CTA position
* Manages administrative tasks: reporting of sales/procedures, outcomes of sales activities, submission of expense reports
Qualifications
Skills, Experience, Education, & Training
* Bachelor's degree required
* Minimum 1-year leadership (military) experience or 1 year of outside sales experience required
* Proven record of success
* Ambition and exceptional work ethic
* Ability to excel in a high-energy, fast-paced environment
* Excellent social skills and persuasive communication skills
* Proven ability to work effectively as part of a team
* Ability to travel up to 10%, and work nights and weekends as needed
Compensation and Benefit Information:
We provide market-competitive compensation packages, inclusive of base pay + commission, benefits and equity. The target pay rate for this position is $114,000.
#LI-REMOTE
Additional Information
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
Mandatory Notices
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target base compensation ranges are listed.
$114k yearly 10d ago
Clinical Research Coordinator - Neonatology - Pediatrics
University of Mississippi Medical Center 4.6
Clinical research coordinator job in Jackson, MS
Hello,
Thank you for your interest in career opportunities with the University of Mississippi Medical Center. Please review the following instructions prior to submitting your job application:
Provide all of your employment history, education, and licenses/certifications/registrations. You will be unable to modify your application after you have submitted it.
You must meet all of the job requirements at the time of submitting the application.
You can only apply one time to a job requisition.
Once you start the application process you cannot save your work. Please ensure you have all required attachment(s) available to complete your application before you begin the process.
Applications must be submitted prior to the close of the recruitment. Once recruitment has closed, applications will no longer be accepted.
After you apply, we will review your qualifications and contact you if your application is among the most highly qualified. Due to the large volume of applications, we are unable to individually respond to all applicants. You may check the status of your application via your Candidate Profile.
Thank you,
Human Resources
Important Applications Instructions:
Please complete this application in entirety by providing all of your work experience, education and certifications/
license. You will be unable to edit/add/change your application once it is submitted.
Job Requisition ID:R00042338Job Category:ResearchOrganization:SOM-Peds-Neonatology-Mgr Research OperationsLocation/s:Main Campus JacksonJob Title:ClinicalResearchCoordinator - Neonatology - PediatricsJob Summary:Responsible for management, execution, and reporting of clinical study results and the supervision of the research team. Coordinates activities for research studies within an assigned area or unit. Directs participant enrollment in research studies and assures integrity of study records. Prepares and submits documentation for institutional and governmental grant progress review and budget monitoring.Education & Experience
Bachelor's Degree in a Health Sciences or related field and at least two (2) years of ClinicalResearch experience. Master's Degree preferred.
Certifications, Licenses or Registration Required: Certified ClinicalResearchCoordinator (CCRC) preferred.
Knowledge, Skills & Abilities
Excellent knowledge of good clinical practice and FDA regulations. Superior oral and written communication skills. Strong interpersonal skills to effectively interact with patients, physicians, staff, and study sponsors. Knowledge and understanding of computer systems, tools, and programs. Ability to assume a leadership role in a team environment. Working knowledge of IRB submissions/amendments, patient screening and consenting. Excellent organizational skills.
Responsibilities
Assumes responsibility for all aspects of study recruitment, screening, enrollment, and visits for eligible participants. Administers study-related procedures & instruments; directs participants for hospital and physician procedures.
Ensures that research personnel are knowledgeable about all components of the study protocol and that staff roles and responsibilities are delineated.
Oversees and manages scheduling, documentation, and follow-ups with research participants. Supervises patient education and referrals.
Monitors study budgets and billings to insure adequacy of funds and compliance with UMMC policies and federal regulations.
Corresponds with study investigators, sponsors, regulatory agencies, and UMMC compliance personnel on matters related to study documentation, records, data and operations.
Prepares IRB documents and progress reports. Oversees maintenance of regulatory documents, files, and reports.
The duties listed are general in nature and are examples of the duties and responsibilities performed and are not meant to be construed as exclusive or all-inclusive. Management retains the right to add or change duties at any time.
Physical and Environmental Demands
Requires frequent exposure to unpleasant or disagreeable physical environment such as high noise level and exposure to heat and cold, frequent handling or working with potentially dangerous equipment, frequent exposure to bio-hazardous conditions such as risk of radiation exposure, blood borne pathogens, fumes or airborne particles, and/or toxic or caustic chemicals which mandate attention to safety considerations, occasional working hours significantly beyond regularly scheduled hours, occasional travelling to offsite locations, occasional activities subject to significant volume changes of a seasonal/clinical nature, occasional work produced subject to precise measures of quantity and quality, frequent bending, occasional lifting and carrying up to 50 pounds, frequent crouching/stooping, occasional driving, occasional kneeling, frequent pushing/pulling, frequent reaching, frequent sitting, frequent standing, frequent twisting, and frequent walking. (occasional-up to 20%, frequent-from 21% to 50%, constant-51% or more)
Time Type:Full time FLSA Designation/Job Exempt:YesPay Class:SalaryFTE %:100Work Shift:DayBenefits Eligibility:Grant Funded:YesJob Posting Date:01/14/2026Job Closing Date (open until filled if no date specified):01/17/2026
$38k-49k yearly est. Auto-Apply 4d ago
Specialist, Clinical Business Operations, Oncology
Sumitomo Pharma 4.6
Clinical research coordinator job in Jackson, MS
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA).
+ Assist with the entry of Contractual Agreements into an electronic document repository.
+ Ensure all outsourcing decisions are properly documented, compliant, and audit-ready.
+ Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate.
+ Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements.
+ Perform other duties as requested.
**Key Core Competencies**
+ Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities
+ Ability to proactively identify and act on opportunities for operational efficiencies
+ Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude
+ Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution
+ Excellent written and oral communication skills
**Education and Experience**
+ BA/BS preferred with at least 2 years experience, or 5 years equivalent experience
+ Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles.
The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at **********************************************
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
$72.5k-90.6k yearly 60d+ ago
Clinical Research Coordinator
Iterative Health
Clinical research coordinator job in Tupelo, MS
Iterative Health is a healthcare technology and services company powering the acceleration of clinicalresearch to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinicalresearch sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
ClinicalResearchCoordinator I
Iterative Health is a healthcare technology and services company powering the acceleration of clinicalresearch to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinicalresearch sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
We are seeking a full-time, experienced ClinicalResearchCoordinator (CRC). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Responsibilities:
Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management.
Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation
Schedule all patient research visits and procedures consistent with protocol requirements
Conduct patient visits as outlined within each study protocol
Dispense study medication, collect vital signs and perform ECGs
Perform blood draws, process and ship specimens per study protocol and IATA regulations
Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms.
Act as point of contact for study participants
Adhere to Research SOPs, Good Clinical Practices, and the study protocols
Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the study
Ensure all safety data is reviewed by the PI in a timely manner
Maintain inventory of study equipment and supplies onsite at all times
Participate actively in communication of status and results to management
Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
Schedule and prepare for monitor visits
Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance
Complete and maintain case report forms per FDA guidelines, and review them against the patient's medical record for completeness and accuracy
Iterative Health Expectations
All employees are expected to:
Perform quality work within deadlines with or without direct supervision
Interact professionally with other employees, customers and suppliers
Work effectively as a team contributor on all assignments
Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations
Qualifications
Medical Assistant, LPN, Associates or Bachelor's degree in a clinical or scientific-related discipline preferred
Minimum 1-2 years of clinicalresearch experience
Strong written and verbal communication skills
Ability to read, interpret, and apply clinic policies and research protocols
Ability to use standard office software
Must be able to lift up to 25 pounds
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
$40k-58k yearly est. Auto-Apply 33d ago
Clinical Research Coordinator
Iterative Scopes Inc.
Clinical research coordinator job in Tupelo, MS
Iterative Health is a healthcare technology and services company powering the acceleration of clinicalresearch to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinicalresearch sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
ClinicalResearchCoordinator I
Iterative Health is a healthcare technology and services company powering the acceleration of clinicalresearch to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinicalresearch sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
We are seeking a full-time, experienced ClinicalResearchCoordinator (CRC). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Responsibilities:
* Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management.
* Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation
* Schedule all patient research visits and procedures consistent with protocol requirements
* Conduct patient visits as outlined within each study protocol
* Dispense study medication, collect vital signs and perform ECGs
* Perform blood draws, process and ship specimens per study protocol and IATA regulations
* Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms.
* Act as point of contact for study participants
* Adhere to Research SOPs, Good Clinical Practices, and the study protocols
* Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the study
* Ensure all safety data is reviewed by the PI in a timely manner
* Maintain inventory of study equipment and supplies onsite at all times
* Participate actively in communication of status and results to management
* Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
* Schedule and prepare for monitor visits
* Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
* Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance
* Complete and maintain case report forms per FDA guidelines, and review them against the patient's medical record for completeness and accuracy
Iterative Health Expectations
All employees are expected to:
* Perform quality work within deadlines with or without direct supervision
* Interact professionally with other employees, customers and suppliers
* Work effectively as a team contributor on all assignments
* Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations
Qualifications
* Medical Assistant, LPN, Associates or Bachelor's degree in a clinical or scientific-related discipline preferred
* Minimum 1-2 years of clinicalresearch experience
* Strong written and verbal communication skills
* Ability to read, interpret, and apply clinic policies and research protocols
* Ability to use standard office software
* Must be able to lift up to 25 pounds
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
$40k-58k yearly est. Auto-Apply 32d ago
Associate-Clinical Laboratory
Baptist Memorial Health Care 4.7
Clinical research coordinator job in Southaven, MS
Responsible for dispatch and/or transport of blood and other specimens. Assists the laboratory staff with clerical and technical tasks indirectly related to the delivery of quality patient care, for the purpose of diagnostic testing. May perform CLIA waived laboratory testing. Performs routine duties in the lab. Performs other duties as assigned.
Responsibilities
Adhere to all specimen collection and preservation requirements, media requirements and storage.
Demonstrates proficiency in receiving specimens in the lab.
Follow accreditation standards, regulatory agency requirements and institutional policies.
Accurate and complete patient identification requirements, using at least three (3) unique patient identifiers.
Demonstrate proficiency in recording and retrieving laboratory data.
Timely distribution of samples.
Proficiency in specimen tracking.
Proficiency in reference lab specimen requirements, receiving and processing.
Proficiency in loading and unloading of blood culture bottles and performing CLIA waived tests.
Assists customers, including answering phones and responding to customer inquiries
Cleans and maintains laboratory supplies and work area
Assists with training and educating new employees and students
Completes assigned goals.
Specifications
Experience
Minimum Required
Preferred/Desired
Education
Minimum Required
Certification/Degree in the following areas which include, but are not limited to medical technology, clinical laboratory, chemical, physical or biological or equivalent years of experience and education.
Preferred/Desired
Training
Minimum Required
Preferred/Desired
Special Skills
Minimum Required
Preferred/Desired
Licensure
Minimum Required
Preferred/Desired
$120k-225k yearly est. 46d ago
Associate-Clinical Laboratory
Baptist 3.9
Clinical research coordinator job in Mississippi
Responsible for dispatch and/or transport of blood and other specimens. Assists the laboratory staff with clerical and technical tasks indirectly related to the delivery of quality patient care, for the purpose of diagnostic testing. May perform CLIA waived laboratory testing. Performs routine duties in the lab. Performs other duties as assigned.
Responsibilities
Adhere to all specimen collection and preservation requirements, media requirements and storage.
Demonstrates proficiency in receiving specimens in the lab.
Follow accreditation standards, regulatory agency requirements and institutional policies.
Accurate and complete patient identification requirements, using at least three (3) unique patient identifiers.
Demonstrate proficiency in recording and retrieving laboratory data.
Timely distribution of samples.
Proficiency in specimen tracking.
Proficiency in reference lab specimen requirements, receiving and processing.
Proficiency in loading and unloading of blood culture bottles and performing CLIA waived tests.
Assists customers, including answering phones and responding to customer inquiries
Cleans and maintains laboratory supplies and work area
Assists with training and educating new employees and students
Completes assigned goals.
Specifications
Experience
Minimum Required
Preferred/Desired
Education
Minimum Required
Certification/Degree in the following areas which include, but are not limited to medical technology, clinical laboratory, chemical, physical or biological or equivalent years of experience and education.
Preferred/Desired
Training
Minimum Required
Preferred/Desired
Special Skills
Minimum Required
Preferred/Desired
Licensure
Minimum Required
Preferred/Desired
$32k-37k yearly est. Auto-Apply 60d+ ago
Clinical Territory Associate - Future Opportunity
Intuitive Solutions 4.7
Clinical research coordinator job in Jackson, MS
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
*Please note:
Candidates must live within or be willing to relocate to the Jackson
to perform the duties of this role.
Primary Function of Position:
The
Clinical Territory Associate
(CTA) is a 24+ month developmental role that will partner with the Jackson team to gain knowledge in all aspects of our business to include technical, clinical, and sales.
Responsibilities:
Assists sales representatives with surgeon trainings, hospitals robotic development, and overall territory management
Guides technical in-services for customers to include OR staff, surgeons, etc.
Sells benefits of advanced technology to existing robotic users to contribute to team overall quotas
Gains experience in goal setting, mapping, and attaining in preparation for quota bearing role to follow CTA position
Manages administrative tasks: reporting of sales/procedures, outcomes of sales activities, submission of expense reports
Qualifications
Skills, Experience, Education, & Training
Bachelor's degree required
Minimum 1-year leadership (military) experience or 1 year of outside sales experience required
Proven record of success
Ambition and exceptional work ethic
Ability to excel in a high-energy, fast-paced environment
Excellent social skills and persuasive communication skills
Proven ability to work effectively as part of a team
Ability to travel up to 10%, and work nights and weekends as needed
Compensation and Benefit Information:
We provide market-competitive compensation packages, inclusive of base pay + commission, benefits and equity. The target pay rate for this position is $114,000.
#LI-REMOTE
Additional Information
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
Mandatory Notices
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target base compensation ranges are listed.
$114k yearly 14h ago
Associate-Clinical Laboratory
Baptist Anderson and Meridian
Clinical research coordinator job in Southaven, MS
Responsible for dispatch and/or transport of blood and other specimens. Assists the laboratory staff with clerical and technical tasks indirectly related to the delivery of quality patient care, for the purpose of diagnostic testing. May perform CLIA waived laboratory testing. Performs routine duties in the lab. Performs other duties as assigned.
Responsibilities
Adhere to all specimen collection and preservation requirements, media requirements and storage.
Demonstrates proficiency in receiving specimens in the lab.
Follow accreditation standards, regulatory agency requirements and institutional policies.
Accurate and complete patient identification requirements, using at least three (3) unique patient identifiers.
Demonstrate proficiency in recording and retrieving laboratory data.
Timely distribution of samples.
Proficiency in specimen tracking.
Proficiency in reference lab specimen requirements, receiving and processing.
Proficiency in loading and unloading of blood culture bottles and performing CLIA waived tests.
Assists customers, including answering phones and responding to customer inquiries
Cleans and maintains laboratory supplies and work area
Assists with training and educating new employees and students
Completes assigned goals.
Specifications
Experience
Minimum Required
Preferred/Desired
Education
Minimum Required
Certification/Degree in the following areas which include, but are not limited to medical technology, clinical laboratory, chemical, physical or biological or equivalent years of experience and education.
Preferred/Desired
Training
Minimum Required
Preferred/Desired
Special Skills
Minimum Required
Preferred/Desired
Licensure
Minimum Required
Preferred/Desired
$48k-123k yearly est. Auto-Apply 46d ago
Senior Clinical Research Associate/Clinical Research Associate II - Oncology - US - FSP
Parexel 4.5
Clinical research coordinator job in Jackson, MS
**Job Purpose:** The Senior ClinicalResearch Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.
**Key Accountabilities:**
**Oversight of Monitoring Responsibilities and Study Conduct**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and
+ recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals
+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Collaboration**
+ Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM)
+ Partners with SCP and Country Study Operations Manager (SOM)
+ When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist)
+ May act as a Mentor for ClinicalResearch Associates
**Skills:**
+ Monitoring Experience: Minimum 3 years relevant experience in clinicalresearch site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
+ Preferred therapeutic experience in Oncology
+ Global clinical trial experience preferred
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Travel (60-80%) within area is required
+ Valid driver's license and passport required
**Knowledge and Experience:**
+ Demonstrated knowledge of clinicalresearch and development processes and ability to gain command of process details
+ Demonstrated knowledge of global and local regulatory requirements
+ Demonstrated understanding of key operational elements of clinicalresearch (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
+ Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)
+ Demonstrated ability to support sponsor regulatory interactions/inspections
+ Demonstrated knowledge of the processes around protocol design and feasibility assessment
+ Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
+ Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial
+ Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation
+ Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required
\#LI-CF1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$84k-110k yearly est. 42d ago
CLINICAL RESEARCH COORDINATOR II
University of Alabama at Birmingham 3.7
Clinical research coordinator job in University, MS
The University of Alabama at Birmingham (UAB), OB/GYN - Maternal & Fetal Medicine, is seeking a ClinicalResearchCoordinator II. Some of the responsibilities for this position include patient screening, recruitment for specific studies, and processing and maintaining lab specimens.
General Responsibilities
* To serve as coordinator for studies and provide support to other team members within the confines of the protocol as directed.
* To support screening and participant eligibility determination, working with more senior team members to ensure compliance.
* To conduct activities in accordance with the protocol, regulations and Good Clinical Practice (GCP).
* To assist with the study life cycle from start-up to closure, i.e., collecting and recording data, recruiting and performing follow-up with participants, scheduling visits and assisting in coordination of lab and fieldwork.
Key Duties & Responsibilities
* Serves as a liaison with medical staff, University Departments, ancillary departments and/or satellite facilities.
* Organizes patient enrollment planning.
* Conducts quality assurance activities. May compile and analyze data.
* Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.
* Participates in the recruitment of participants through screening efforts, including the conduction of the consent process according to regulatory guidelines.
* Coordinates care and/or follow-up functions of the study, including planning and developing related activities.
* Arranges access to study medications, as needed, including authorization for prescriptions.
* Employs strategies to maintain recruitment and retention rates.
* Processes and maintains lab specimens.
* Manages site supplies and performs administrative duties in support of research conduction as needed.
* Involved in the study feasibility process and may assist in budget development and billing procedures.
* Prepares and submits multiple levels of research documentation (i.e. IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms). May manage investigational products (IP), including their administration to participants.
* Employs the required system (including personnel) for handling, dispensing, and documenting IP for sponsored protocols.
* In conjunction with Investigators, plans and implements the clinical protocol's goals and objectives.
* Compiles, edits, and proofs written reports for both internal and external administrative offices.
* Provides data for the creation of study budgets as needed.
* Completes Case Report Forms (CRF) according to protocol.
* Documents Adverse Events (AEs) and Serious Adverse Events (SAEs) as required by protocol and regulatory guidance.
* Assists with the development of standard operating procedures (SOPs) for data quality assurance.
* Performs vendor analysis and equipment configuration as needed. May perform a variety of medical procedures and assist in developing orders in the Electronic Medical Record (EMR).
* Under the oversight of the Investigator, develops protocols, identifies efficiencies, and improves processes.
* Serves as a mentor and provides guidance to junior staff, including student assistants.
* Maintains compliance with federal, state, and accrediting agencies (sponsors).
* Maintains any required documentation. Has a working knowledge of institutional and departmental policies and processes.
* Attends study, departmental, and institutional trainings and meetings as required.
* Performs other duties as assigned.
Annual Salary Range: $50,050 - $81,330
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.
Preferences
* Candidate must have effective verbal and written communication.
* This position also requires working independently as well as within a team.
UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.
$50.1k-81.3k yearly 4d ago
Clinical Research Coordinator
Iterative Health
Clinical research coordinator job in Flowood, MS
Iterative Health is a healthcare technology and services company powering the acceleration of clinicalresearch to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinicalresearch sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
ClinicalResearchCoordinator I
Iterative Health is a healthcare technology and services company powering the acceleration of clinicalresearch to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinicalresearch sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
We are seeking a full-time, experienced ClinicalResearchCoordinator (CRC). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Responsibilities:
Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management.
Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation
Schedule all patient research visits and procedures consistent with protocol requirements
Conduct patient visits as outlined within each study protocol
Dispense study medication, collect vital signs and perform ECGs
Perform blood draws, process and ship specimens per study protocol and IATA regulations
Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms.
Act as point of contact for study participants
Adhere to Research SOPs, Good Clinical Practices, and the study protocols
Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the study
Ensure all safety data is reviewed by the PI in a timely manner
Maintain inventory of study equipment and supplies onsite at all times
Participate actively in communication of status and results to management
Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
Schedule and prepare for monitor visits
Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance
Complete and maintain case report forms per FDA guidelines, and review them against the patient's medical record for completeness and accuracy
Iterative Health Expectations
All employees are expected to:
Perform quality work within deadlines with or without direct supervision
Interact professionally with other employees, customers and suppliers
Work effectively as a team contributor on all assignments
Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations
Qualifications
Medical Assistant, LPN, Associates or Bachelor's degree in a clinical or scientific-related discipline preferred
Minimum 1-2 years of clinicalresearch experience
Strong written and verbal communication skils
Ability to read, interpret, and apply clinic policies and research protocols
Ability to use standard office software
Must be able to lift up to 25 pounds
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
$40k-58k yearly est. Auto-Apply 33d ago
Clinical Research Coordinator
Iterative Scopes Inc.
Clinical research coordinator job in Flowood, MS
Iterative Health is a healthcare technology and services company powering the acceleration of clinicalresearch to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinicalresearch sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
ClinicalResearchCoordinator I
Iterative Health is a healthcare technology and services company powering the acceleration of clinicalresearch to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinicalresearch sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
We are seeking a full-time, experienced ClinicalResearchCoordinator (CRC). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Responsibilities:
* Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management.
* Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation
* Schedule all patient research visits and procedures consistent with protocol requirements
* Conduct patient visits as outlined within each study protocol
* Dispense study medication, collect vital signs and perform ECGs
* Perform blood draws, process and ship specimens per study protocol and IATA regulations
* Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms.
* Act as point of contact for study participants
* Adhere to Research SOPs, Good Clinical Practices, and the study protocols
* Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the study
* Ensure all safety data is reviewed by the PI in a timely manner
* Maintain inventory of study equipment and supplies onsite at all times
* Participate actively in communication of status and results to management
* Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
* Schedule and prepare for monitor visits
* Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
* Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance
* Complete and maintain case report forms per FDA guidelines, and review them against the patient's medical record for completeness and accuracy
Iterative Health Expectations
All employees are expected to:
* Perform quality work within deadlines with or without direct supervision
* Interact professionally with other employees, customers and suppliers
* Work effectively as a team contributor on all assignments
* Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations
Qualifications
* Medical Assistant, LPN, Associates or Bachelor's degree in a clinical or scientific-related discipline preferred
* Minimum 1-2 years of clinicalresearch experience
* Strong written and verbal communication skils
* Ability to read, interpret, and apply clinic policies and research protocols
* Ability to use standard office software
* Must be able to lift up to 25 pounds
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
$40k-58k yearly est. Auto-Apply 32d ago
Clinical Territory Associate - Future Opportunity
Intuitive 4.7
Clinical research coordinator job in Jackson, MS
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
*Please note: Candidates must live within or be willing to relocate to the Jackson to perform the duties of this role.
Primary Function of Position:
The Clinical Territory Associate (CTA) is a 24+ month developmental role that will partner with the Jackson team to gain knowledge in all aspects of our business to include technical, clinical, and sales.
Responsibilities:
Assists sales representatives with surgeon trainings, hospitals robotic development, and overall territory management
Guides technical in-services for customers to include OR staff, surgeons, etc.
Sells benefits of advanced technology to existing robotic users to contribute to team overall quotas
Gains experience in goal setting, mapping, and attaining in preparation for quota bearing role to follow CTA position
Manages administrative tasks: reporting of sales/procedures, outcomes of sales activities, submission of expense reports
Qualifications
Skills, Experience, Education, & Training
Bachelor's degree required
Minimum 1-year leadership (military) experience or 1 year of outside sales experience required
Proven record of success
Ambition and exceptional work ethic
Ability to excel in a high-energy, fast-paced environment
Excellent social skills and persuasive communication skills
Proven ability to work effectively as part of a team
Ability to travel up to 10%, and work nights and weekends as needed
Compensation and Benefit Information:
We provide market-competitive compensation packages, inclusive of base pay + commission, benefits and equity. The target pay rate for this position is $114,000.
#LI-REMOTE
Additional Information
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
Mandatory Notices
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target base compensation ranges are listed.
$114k yearly 9d ago
Sr. Clinical Research Associate - FSP
Parexel 4.5
Clinical research coordinator job in Jackson, MS
**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The ClinicalResearch Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
**Key Accountabilities** :
**Site Management Responsibilities**
+ Contributes to the selection of potential investigators.
+ In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
+ Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
+ Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
+ Actively participates in Local Study Team (LST) meetings.
+ Contributes to National Investigators meetings, as applicable.
+ Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
+ Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
+ Updates CTMS and other systems with data from study sites as per required timelines.
+ Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
+ Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits.
+ Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
+ Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
+ Ensures data query resolution in a timely manner.
+ Works with data management to ensure robust quality of the collected study data.
+ Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
+ Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
+ Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
+ Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
+ Assists site in maintaining inspection ready ISF.
+ Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
+ Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
+ Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
+ Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
+ Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager.
**Compliance with Sponsor Standards**
+ Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).
+ Ensures compliance with local, national, and regional legislation, as applicable.
+ Completes timesheets accurately as required.
**Compliance with Parexel Standards**
+ Complies with required training curriculum.
+ Completes timesheets accurately as required.
+ Submits expense reports as required.
+ Updates CV as required.
+ Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.
**Skills (Essential):**
+ Excellent attention to detail.
+ Good written and verbal communication skills.
+ Good collaboration and interpersonal skills.
+ Good negotiation skills.
+ Proficient in written and spoken English language required.
+ Fluency in local language(s) required.
**Skills (Desirable):**
+ Ability to work in an environment of remote collaborators.
+ Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
+ Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
+ Good analytical and problem-solving skills.
+ Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
+ Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
+ Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
**Knowledge and Experience (Essential)** **:**
+ Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
+ Good knowledge of relevant local regulations.
+ Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
+ Basic understanding of the drug development process.
+ Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
**Knowledge and Experience (Desired):**
+ Familiar with risk-based monitoring approach including remote monitoring.
+ Good cultural awareness.
**Education:**
+ Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
**Other:**
+ Ability to travel nationally/internationally as Required
+ Valid driving license per country requirements, as applicable.
LI-LG4
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$84k-110k yearly est. 39d ago
CLINICAL RESEARCH COORDINATOR II
University of Alabama at Birmingham 3.7
Clinical research coordinator job in University, MS
The University of Alabama at Birmingham (UAB), Psych - Behavioral Neurobiology, is seeking a ClinicalResearchCoordinator II. This position will be involved in screening, recruitment, enrollment planning, consenting, running study visits (administer computer tasks, collect questionnaire data, blood samples, saliva samples), train junior team members, maintain subject-level and study-level documentation, collect and report AE data, submit annual reports, prepare and submit IRB documentation, monitor data flow, conduct QA, maintain study team compliance with training requirements, process and store samples, manage supplies, assist with SOP development, and attend trainings and meetings for two studies (observational neuroimaging study and randomized clinical trials) with patients with Functional Neurological Disorder and matched controls.
General Responsibilities
* To serve as coordinator for studies and provide support to other team members within the confines of the protocol as directed.
* To support screening and participant eligibility determination, working with more senior team members to ensure compliance.
* To conduct activities in accordance with the protocol, regulations and Good Clinical Practice (GCP).
* To assist with the study life cycle from start-up to closure, i.e., collecting and recording data, recruiting and performing follow-up with participants, scheduling visits and assisting in coordination of lab and fieldwork.
Key Duties & Responsibilities
* Schedules participants and conducts visits for all studies independently, including baseline and post-treatment visits and neuro-imaging visits. This includes proactively reaching out to treating Psychologists and scheduling follow-up visits to align with anticipated treatment completion.
* Administers computer tasks during fMRI and outside of the scanner. Administers questionnaires and collects blood and saliva samples.
* Trains others to conduct and document visits and protocol-specific testing/interviews.
* Assists with development and follows procedures and documentation of study payment in a timely fashion.
* Participates in recruitment of participants through screening efforts, including pre-screening medical records of potential participants on the waitlist for the FND treatment clinic, administering a structured interview (QuickSCID-5) for the purposes of matching FND patients and controls, and consenting participants according to regulatory guidelines.
* Employs strategies to maintain recruitment and retention rates. Provide oversight and training to study team members who screen and consent participants.
* Maintains subject-level documentation for all studies independently.
* Provides oversight and training to study team members who maintain subject-level documentation, including documentation in the Electronic Medical Record.
* Maintains training requirements and develops solutions to proactively ensure study team members' compliance with training requirements.
* Independently maintains appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of records, etc.
* Maintains study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, etc.).
* Oversees maintenance of Delegation of Authority Logs and training of key personnel on study-specific duties.
* Involved in the study feasibility process and may assist in budget development and billing procedures.
* Prepares and submits multiple levels of research documentation (i.e. IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms).
* Processes blood and saliva samples in preparation for storage in the freezer.
* Manages site supplies (e.g., Vacutainers, butterfly needles, gauze, medical tape, Salivettes) and performs administrative duties in support of research conduction as needed.
* Trains junior staff in the ethical conduct of research and provides guidance on strategies used to maintain safety.
* Summarizes and clarifies for study teams the professional guidelines and code of ethics related to the conduct of clinicalresearch.
* Collects adverse event information independently and submits adverse event reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms).
* Completes Case Report Forms (CRF) according to protocol.
* Assists with the development of standard operating procedures (SOPs) for data quality assurance.
* Organizes patient enrollment planning.
* Conducts quality assurance activities.
* Compiles and analyzes data.
* Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected. This includes transferring neuroimaging data to a shared server and uploading data onto the supercomputer for analysis.
* Maps protocol data flow.
* Predicts areas of vulnerability for a protocol's data flow plan.
* Determines areas where data provenance may be compromised.
* Attends study, departmental, and institutional trainings and meetings as required, including weekly scheduled lab meetings, and performs other duties as assigned.
* Performs other duties as assigned.
Annual Salary Range: $50,050 - $81,330
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.
Preferences
* A bachelor's degree in Psychology, Neuroscience, or a related field is preferred.
* Experience working with medical populations and coordinatingclinicalresearch studies.
UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.
$50.1k-81.3k yearly 8d ago
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