Clinical Research Associate 1
Clinical research associate job in New Orleans, LA
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1 -2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi -task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self -motivated, assertive, and driven
BenefitsDental, Medical, Vision, PTO and 401K
Senior Clinical Research Associate/Clinical Research Associate II - Oncology - US - FSP
Clinical research associate job in Baton Rouge, LA
**Job Purpose:** The Senior Clinical Research 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 Clinical Research Associates
**Skills:**
+ Monitoring Experience: Minimum 3 years relevant experience in clinical research 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 clinical research 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 clinical research (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.
Trial Master File (TMF) Specialist Oncology
Clinical research associate job in Baton Rouge, LA
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.
The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF.
**Key Responsibilities**
+ Responsible for overall quality, maintenance, and completeness of Trial Master Files.
+ Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues.
+ Develop project specific TMF plan and structure and update the plan as needed.
+ Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained.
+ Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements.
+ Act as a liaison between the Site IRBs and study team to resolve queries and concerns.
+ Provide study team reports or updates regarding status of TMF on a regular basis.
+ Participate in audits and provide documents as requested.
+ Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings.
+ Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings.
+ Champion best practices for building and maintaining TMF health.
**Professional Experience / Qualifications**
+ BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings
+ Knowledge of and direct experience with Trial Master Files.
+ Prior eTMF (e.g. Veeva) administration required.
+ Strong Microsoft Office skills required.
+ Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2).
+ Fundamental knowledge of the conduct of clinical trials is preferred.
+ Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment.
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_
CLINICAL TRIALS COORDINATOR 3
Clinical research associate job in Baton Rouge, LA
The Clinical Trials Coordinator 3 will work collectively within a multidisciplinary clinical/research team to ensure that all aspects of patient management are executed both timely and accurately. Incumbent must be comfortable working independently, managing interactions with and between team members, both internally and externally; ensuring that all NIH grant funded, industry-sponsored or investigator driven studies/trials are managed to the highest quality to ensure safety and effectiveness.
The incumbent will promote improved access for patients to clinical trials, and facilitate research activities throughout LSUHSC-affiliated clinics and partner hospitals as assigned.
The incumbent will also prepare and edit clinical study protocols and scientific documents.
Associate-Clinical Laboratory
Clinical research associate job in Oxford, 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
Applied Research Coordinator
Clinical research associate job in New Orleans, LA
The Water Institute is an independent, applied research organization that advances actionable research, technology, and planning in support of inclusive, science-informed decision making. We serve as a thought partner, bridging diverse disciplines and organizations. Headquartered in Baton Rouge, La, we draw on our roots in the Mississippi River Delta and Gulf Coast, where water is both a strength and a vulnerability, to tackle challenges wherever they are. Our mission is to reduce the vulnerability of people, communities, ecosystems, and economies through transformative approaches to interconnected environmental and social challenges. More information about the Water Institute can be found at **************************
In 2023, The Water Institute founded the Community Resilience Center (Center) to increase climate resilience by addressing systemic barriers and making available more capacity and expertise to support community-led resilience across the Gulf. The Center works with communities to move beyond the assessment and study of risk towards the exploration, co-development, and implementation of community-focused strategies to increase resilience at every level: from individual to household, block to neighborhood, and state to federal.
The Center focuses on resilience to our changing climate and the resulting cascading and compounding impacts, with an explicit emphasis on addressing systemic barriers and processes that reinforce disparate impacts. Learn more here: Center Strategic Plan. In furtherance of the Center's mission and vision, the Community Resilience Catalyst Program was launched in spring 2025 to remove financial and administrative barriers for communities, allowing them to focus on advancing their resilience goals. The Catalyst program provides eligible communities with tailored information around community-led resilience and direct technical support via a low-effort request form.
Position Description
The Water Institute is looking for an experienced Applied Research Coordinator to support the Chief Scientist primarily and provide additional support to divisional leadership, as directed, to ensure that organization's goals, priorities, and objectives are accomplished and that operations run efficiently. Additionally, the Center is seeking support to implement the expansion of the Community Resilience Catalyst to serve the broader Gulf Coast. The position will support all aspects of the Catalyst Program working with a range of teammates, topics, stakeholders, and external partners. The position will be located in Louisiana at our office on the UNO campus in New Orleans.
The ideal candidate will be a proactive problem solver with exceptional communication skills and meticulous attention to details. This person should have experience working in an office environment, performing administrative duties, and providing support to leadership. Given the dynamic nature of the organization, we will rely on this role to be flexible and consistent while maintaining the confidentiality of high-level systems and operations. Additionally, it is expected that the successful candidate will be able to connect across technical fields, translate research into practice, and communicate with a wide range of audiences. This person needs a high comfort level working and interacting with diverse and technical collaborators, decision makers, stakeholders, and coastal residents.
Roles and Responsibilities
Manage and organize calendars and appointments to optimize Chief Scientist's time and as requested for divisional leadership.
Coordinate complex scheduling and calendar management, as well as content and flow of information to Chief Scientist and as requested to divisional leadership. This may include setting agendas, taking notes, following up on action items, tracking questions and routing appropriately, and ensuring answers are provided to the questions.
Maintain and refine internal processes that support Chief Scientist and division as requested and coordinate internal and external resources to expedite workflows.
Manage communication with employees by liaising as needed internally and externally on various projects and tasks.
Plan and orchestrate in-person meeting and workshop logistics by organizing meeting locations and participants, booking spaces, tracking invitations and responses, purchasing supplies, setting up and breaking down meetings, printing materials to support AR billable projects
Manage Chief Scientist's travel logistics and activities, including accommodations, transportation, and meals and provide same assistance for other divisional leaders as needed.
Provide administrative and office support, such as typing, dictation, spreadsheet creation, faxing, and maintenance of filing system and contacts database.
In conjunction with Institute Office Administrator, manage office-management duties for the New Orleans office such as reporting maintenance issues, setting up for new hires and meetings, assisting with receiving and organizing of supplies, being a liaison with IT, etc.
Maintain professionalism and strict confidentiality with all materials.
Design and implement stakeholder outreach and engagement including one-on-one meetings, emails, social media, workshops, and trainings.
Communicating technical findings and other information and concepts through a variety of modes including memos, reports, one-pagers, and infographics.
Perform other related duties as assigned.
Required Qualifications:
Bachelor's degree with one-year work experience in environmental science, stakeholder engagement, conservation, community resilience, public policy, planning, political science, or a related field.
Five plus years of proven experience in an administrative role reporting directly to senior management
At least 2 years of experience in an organization that works in science and/or natural resource management
Excellent written and verbal communication skills
Strong time-management skills and an ability to organize and coordinate multiple concurrent projects
Demonstrated ability to communicate openly and effectively to build rapport, trust, and collaborative relationships with a wide range of partners, organizations, and agencies.
Ability to implement multimodal outreach and engagement strategies (e.g., virtual platforms, in-person, phone and email campaigns, workshops, trainings, social media, etc.).
Proficiency with office productivity tools and an aptitude for learning new software and systems
Flexible team player, willing to adapt to changes and unafraid of challenges
Proactive and positive attitude to problem solving, ability to work independently, and self-motivated.
Ability to maintain confidentiality of information related to the company and its employees
Desired Qualifications:
8+ years of experience in organizations that work in science and/or natural resource management strongly desired.
Experience working in interdisciplinary project teams, in or with the public sector, with communities on the Gulf Coast, with community organizing.
Specific technical skills to complement the Institute's existing technical services, which could include:
Graphic design and/or urban design skills
Data visualization
Expertise in developing and conducting meaningful community engagement practices
Social science research methods
Expertise in risk, vulnerability, and/or benefit-cost analysis
Workload will vary from week to week, and candidates will be flexible and willing to occasionally work evenings and weekends. Regular travel is expected for local travel in state of LA and surrounding states (mostly same day trips) and some travel outside of the state.
The Water Institute is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
The hiring pay for the position starts at $54,000 and a final determination is based on the skills, education, and/or experience of the successful candidate. We believe in the importance of pay equity and consider the internal equity of our current staff as part of any final offer. We also offer a generous benefits package for full-time exempt positions.
Unique Benefits of a Water Institute Career
Flexibility: We understand that our team members have different needs and do our best to work with their schedules and provide benefits and resources to meet these needs.
Inclusive environment: We are committed to building an inclusive environment where all teammates feel comfortable and supported.
Fun! We love to keep things fun, both within our work and at company-wide events.
Work life balance: We are respectful of people's boundaries and support that through Institute values so that our team has time to recharge and do their best work within the mission of the organization.
Growth opportunity: We are always learning and developing new research methodologies and working with partners to solve problems. You will have the opportunity to engage in growing and leading research with ample opportunities to take ownership and flourish.
The Water Institute Values: Scientific Integrity, Excellence, Transdisciplinary Collaboration, Accountability, Diversity, Work/Life Balance, Respect, Impact
Auto-ApplyClinical Research Coordinator
Clinical research associate job in Shreveport, LA
Description:
Applicants must be legally authorized to work in the United States. We are unable to provide visa sponsorship now or in the future.
The Clinical Research Coordinator (CRC) is primarily responsible for clinical research activities ensuring compliance with Code of Federal Regulation (CFR) Title 21, The Spine Network (TSN) Quality Program, and Good Clinical Practice (GCPs). The CRC is responsible for the day-to-day management of clinical trials, ensuring research studies run smoothly by consenting eligible participants, collecting accurate data, monitoring participant safety, and upholding compliance with regulatory guidelines, all while working closely with Sponsor and study sites to adhere to the study protocol and ethical standards throughout the research process.
Supervisory Responsibilities: None.
Duties/Responsibilities:
Study Compliance and Coordination
Ensure all study procedures adhere to protocols, organizational policies, and regulatory guidelines
Stay updated on and apply GCP standards and Institutional Review Board (IRB) requirements
Participant Management
Identify and screen potential study participants through medical record reviews and interviews
Obtain and document informed consent, clearly explaining study procedures and potential risks
Coordinate and conduct study visits, including collecting and processing samples, administering questionnaires
Record accurate data from study visits, including patient demographics, medical history, and study-specific measurements
Regulatory and Documentation
Prepare and manage study-related documents, including protocol worksheets, IRB submissions, adverse event reports, and progress updates
Maintain and review the Trial Management File (TMF) and other regulatory documentation as necessary
Data and Quality Oversight
Monitor and record study data accurately, ensuring compliance with study protocols and reporting guidelines
Prepare for and participate in quality assurance audits conducted by sponsors, federal agencies, or internal review groups
Collaboration and Communication
Coordinate with investigators, healthcare professionals, and study team members to ensure seamless study execution
Build and maintain relationships with investigators, site staff, vendors, and contractors
Review and address protocol issues, proposing resolutions or updates when required
Additional Responsibilities
Participate in continuing education and to maintain professional competency
Perform other duties as assigned to support study success
Requirements:
Required Skills/Abilities:
Familiarity with Electronic Medical Record (EMR) and radiology systems (PACS)
Strong organizational and time management skills
ACRP-CP or CCRC certified or willingness to obtain certification
Attention to detail and accuracy in data collection and documentation
Proficient in Microsoft Office applications (e.g., WORD, Excel, PowerPoint, Outlook, etc.) and electronic data capture (EDC) platforms
Excellent communication, written and organizational skills (i.e., ability to prioritize a number of tasks of varying complexity), along with problem solving, and conflict resolution
Ability to motivate and collaborate with other functional teams and/or departments as necessary
Ability to work independently, take initiative, and meet TSN goals for study projects within timelines and budget requirements
Able to function in an environment where multiple competing tasks occur
Education and Experience:
Bachelor's degree or equivalent combination of education and/or experience in science or health-related field
2 years of experience in clinical research in the medical device and/or pharmaceutical industry with IDE and/or IND experience preferred
Clinical research experience outside the U.S. is helpful but not required
Working knowledge of Food and Drug Administration (FDA) regulations and GCP guidelines
Work Environment:
Prolonged periods of sitting at a desk and working on a computer
Required to use hands/fingers to type and handle materials
Must be able to lift up to 15 pounds at times
Work Authorization:
Applicants must be legally authorized to work in the United States. We are unable to provide visa sponsorship now or in the future.
EEO Statement:
The Spine Network is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.?
Faculty Clinical Coordinator
Clinical research associate job in Metairie, LA
To participate in a remote work arrangement, employees must reside in the United States. No remote work arrangement will be considered for working from outside the United States. Current employee, faculty or adjunct instructor at Herzing University (not a Contractor or temporary employee through a staffing agency): log into UKG and navigate to Menu > Myself > My Company > View Opportunities to apply using the internal application process.
The Faculty Clinical Coordinator will ensure that all assigned faculty meet the credentialing requirements of assigned facilities and that all required paperwork is submitted to the clinical facilities within the required time frame. The coordinator implements and teaches an orientation program for all clinical faculty to ensure that program outcomes are being met. The coordinator documents that the site is meeting accreditation standards at least once per clinical rotation through a site visit or other communication means. Faculty observations will be conducted and documented as appropriate per accreditation requirements.
Requirements:
* Hold a Graduate degree in nursing.
* Hold an unencumbered RN nursing license. Hold a WI Compact license or have the ability to obtain.
* Minimum of 2 years experience in as a nurse education within a professional setting OR faculty member within a nursing program at an institution of higher education.
* Be proficient with Microsoft Office Suite and internet applications, as well as, be proficient with other technologies currently used in clinical settings.
* Experience supervising faculty within a clinical setting is preferred.
* Experience teaching nursing students is preferred.
* Leadership experience is preferred.
PAY:
Compensation is determined based on the qualifications, experience, and circumstances of each hire. It is uncommon for new employees to start near the top of the salary range. We offer a comprehensive benefits package, including a tuition waiver and reimbursement program, health insurance, paid time off, and a retirement savings plan with company match. The salary range for this position is $81,800 to 115,800.
Click Here to learn more about careers at Herzing University.
Clinical Coordination Duties:
* Maintain an up-to-date knowledge of the profession to include trends in practice and education, compliance with governing body's policies and procedures, competitive and collaborative practices with regards to other programs in the area, and any other information regarding practice that might impact the achievement of program outcomes.
* Identify, select, contract with, monitor, and evaluate all clinical sites.Maintain site selection criteria and contract documentation in support of competency requirements.
* Visit all clinical sites at least once each rotation to ensure sites continue to support a relevant and comprehensive experience as appropriate.
* Work in conjunction with the program administrator to establish clinical schedules and evaluate student clinical learning experiences.
* Work in conjunction with the internship/practicum course coordinator to place students for their internship/practicum assignment.
* Advise the program administrator on program areas of interest, i.e. industry trends; program statistics, analysis, and recommendations; clinical site availability, opportunities, and appropriateness; student performance; areas of concern, etc.
* Provide recommendations and address concerns to the program administrator on the competency and clinical management skills of clinical faculty, as well as compliance with clinical facility policies and procedures.
* Participate in the program planning process.
* Comply with all policies and procedures and make recommendations for changes when appropriate.
* Establish and maintain a system to ensure the timely and accurate completion and submission of facility, campus, system, government and accrediting agency reports related to the clinical experience.
* Participate in Partner relations including, but not limited to, active participation in related professional associations, and building business connections in the community.
* Ensure all necessary facility-required documentation and training is completed in a timely and appropriate manner.
* Provide orientation, training, and development guidance to faculty and students regarding their clinical site.
* Assist the program administrator with the evaluation and training of clinical instructors.
* Provide recommendations to the program administrator concerning the upkeep and purchase of subject-specific hardware, software and other media
* Serve as the first point of contact for resolution of clinical personnel issues, which may arise between staff at the clinical site and clinical faculty and students. Engages program administrator as appropriate in facilitating the resolution of clinical personnel issues if further intervention is needed.
* Participate in course meetings arranged by the course leads to ensure that clinical settings are meeting the needs of the course.
* Support and constructively contribute to campus decision-making processes.
* Provide advisement support regarding clinical expectations and performance to students.
* Participate in professional development activities, professional organizations, and partnership activities.
* Accept and complete additional related duties as assigned by the program administrator.
Faculty Duties:
The primary duties and responsibilities of faculty members at Herzing University are organized according to eight competencies which serve as the basis for instructor hiring, evaluation and development.
* Subject Matter Expertise
* Effective Communication
* Pedagogical Mastery
* Operational Excellence
* Appreciation and Promotion of Diversity
* Assessment of Student Learning
* Utilization of Technology to Enhance Teaching and Learning
* Continuous Improvement
Herzing University is committed to providing a diverse environment and is dedicated to fostering a culture and atmosphere of mutual respect. It provides an inclusive and collegial community where individuals are valued, heard and empowered to contribute to the effectiveness of the institution.
Physical Requirements:
* Must be able to remain in a stationary position most of the time.
* Must be able to occasionally move around the work location.
* Must be able to communicate information and ideas so others will understand.
* Constantly operates office and/or tech equipment which may include computers, copiers, fax machines, audio/visuals.
* Frequently uses voice and hearing to communicate with students, staff or colleagues face-to-face or over the telephone.
* Visually or otherwise identify, observe and assess.
* Occasionally move, carry, or lift 10 pounds.
Applicants must be authorized to work for any employer in the U.S. We do not sponsor or take over sponsorship of an employment Visa at this time.
It is the university's practice to recruit and hire without discrimination because of skin color, gender, religion, LGBTQi2+ status, disability status, age, country of birth, veteran status, or any other status protected by law. ***************************************
Herzing University prohibits sex-based discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. The notice of nondiscrimination is located at *********************************
Senior Clinical Research Coordinator
Clinical research associate job in New Orleans, LA
The primary responsibility of the Senior Clinical Research Coordinator is to manage all aspects of conducting clinical trials and other epidemiological studies related to cardiovascular disease. The Senior Clinical Research Coordinator supervises and directs the activities of workers engaged in clinical research project to ensure compliance with protocols and overall clinical objectives. The Senior Clinical Research Coordinator is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for the protocol, the Senior Clinical Research Coordinator acts as a liaison between the patient, investigator, collaborators, Institutional Review Board and sponsor. The Senior Clinical Research Coordinator recruits, screens, enrolls and follows study patients, and performs and supervises the associated data collection, entry, and quality control activities, ensuring protocol compliance and close patient monitoring, and works independently in designing, coordinating, and implementing all assigned research projects. The Senior Clinical Research Coordinator is responsible for all data and source documentation, adverse event reporting and maintenance of complete regulatory files. The Senior Clinical Research Coordinator trains other staff in conducting, and may also perform as needed, simple procedures (ecgs, vital signs, etc.), as well as laboratory processing, as called for by the study protocol(s). The Senior Clinical Research Coordinator serves as a key management and administrative role for all clinical research projects conducted in a department by supervising Clinical Research staff to ensure compliance with protocol, federal, and institutional requirements.
* Experience supervising and training research staff, including organizing, prioritizing, and scheduling work assignments in a clinical or medical setting.
* Excellent organization, analytical, interpersonal, and communication skills
* Proficient in various software programs (including database management [e.g. Access], presentation packages [e.g. PowerPoint], spreadsheets [e.g. Excel], and advanced word processing [e.g. Word]).
* Must be able to interact well with patients and the general public
* Ability to work independently and efficiently
* Ability to maintain confidentiality in all work performed
* Skilled in coordinating and organizing meetings and/or special events and willingness to assume additional duties when necessary
* Highly organized and detail oriented, in order to ensure all study procedures are completed as described in the study protocol and to ensure participants are contacted at the correct date and time for the conduct of study assessments
* Willing to travel to conduct clinic site visits and to attend steering committee meetings.
* Be available to study participants on weekends and evenings for emergency situations or answer questions as needed
* Bachelor's Degree or Registered Nurse with current state licensure at the time of hire and 5 years of related work experience
OR
* Master's Degree in a related field and 2 years of related experience
* Certification as a Certified Clinical Research Coordinator (CCRC through the Association of Clinical Research Professionals or ACRP) OR Certified Clinical Research Professional (CCRP through the Society of Clinical Research Associates or SoCRA)
* Master's Degree in Epidemiology, Clinical Research, or Public Health
* Clinical research experience writing Study Protocols and Manuals of Procedures
Clinical Research Project Coordinator
Clinical research associate job in Baton Rouge, LA
This position provides research project support to requesting department to ensure timelines and effectiveness in activation and completion of needed research projects. Responsible for routine to moderately complex project coordination / project management as well as communication and documentation as required by the research
departments.
**Please note that a video interview through Microsoft Teams will be required as well as potential onsite interviews and meetings**
We are committed to offering flexible work options where approved and stated in the job posting. However, we are currently not considering candidates who reside or plan to reside in the following states: **California, Connecticut, Hawaii, Illinois, New York, Rhode Island, Vermont, and Washington**
**Essential Functions**
+ **Research Support and Administration:** Support various clinical research studies and departments across the Intermountain system. Based on role, may coordinate (1) review of IRB/HRPP submissions and provide support to research oversight committees and research programs, coordinate review and oversee submission, or (2) centralized administrative and technical functions associated with grants, contracts and other agreements from external funding sources.
+ **Project Planning & Execution:** Define, develop, and execute clinical research project plans, including work plans and schedules. Identify needed resources, roles, and responsibilities for assigned studies. Facilitate feedback from key participants and participate as a team member when needed.
+ **Budget & Scope Management:** Develop comprehensive budget and scope documents for clinical research studies. Assist with business case and proposal development, including budget preparation and completion of required forms for internal and external routing.
+ **Study Requirements & Compliance:** Analyze study requirements to ensure sponsor and study requirements are met. Communicate impacts on existing studies to internal and external stakeholders. Look for cost-effective methods to facilitate study execution while meeting functional and regulatory requirements.
+ **Quality Assurance & Documentation:** Participate in quality assurance plans and reviews as requested. Document clinical research study deliverables, track and communicate timelines, and prepare reports and presentations on findings. Ensure completion of deliverables per specified deadlines. Support research billing by reviewing research accounts and reconciling invoices.
+ **Study Lifecycle Management:** Manage study startup, maintenance, and closeout activities. Provide support and guidance to Clinical Research study teams on study financials, and act as a source expert and liaison. As requested, provide support and back up as clinical research coordinator.
+ **Medicare Coverage Analysis:** Support the development of Medicare Coverage Analysis for clinical trials. Draft and prepare coverage analysis documents, review reimbursement guidelines, ensure correct billing, and provide coverage review.
+ **Auditing & Risk Management:** Coordinate project assessments and response planning. Communicate risks, develop and execute strategies, and lead auditing activities to ensure compliance with guidelines and regulations.
**Skills**
+ Budgeting
+ Financial negotiation
+ Attention to detail
+ Multitasking
+ Clear written and verbal communication
+ Task Prioritization
+ Process Improvement
+ Critical thinking
+ Collaboration
+ Research
**Physical Requirements**
+ Ongoing need for employee to see and read information, labels, monitors, etc. and to see to identify equipment and supplies and to utilize a wide variety of information including organizing and completing documentation and forms, accessing and entering computer information, and identifying needs and urgent issues.
+ Frequent interactions with providers, colleagues, customers, patients/clients, and visitors that require employee to verbally communicate as well as hear and understand spoken information, needs, and issues quickly and accurately.
+ Manual dexterity of hands and fingers to manipulate complex and delicate equipment with precision and accuracy. This includes frequent computer use and typing for documenting patient interactions, accessing needed information, operating telephones and other office equipment, including manipulating paper - requiring the ability to move fingers and hands.
+ Expected to bend, lift, and carry patient files, documents, equipment, and supplies.
+ Remain sitting or standing for long periods of time while interacting with others or to perform work on a computer, telephone, or other equipment.
+ For roles requiring driving: Expected to drive a vehicle which requires sitting, seeing and reading signs, traffic signals, and other vehicles.
**Physical Requirements:**
**Minimum Qualifications**
+ Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills; Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills: Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment.
+ Demonstrated experience working in a collaborative team environment.
+ Experience using word processing, spreadsheet, database, internet, e-mail, and scheduling applications.
+ Ability and willingness to travel within the Intermountain system and work from different locations as assigned. Occasional overnight travel may be required.
+ Clinical licensure, experience or certification may be required due to grant funding requirements. · Bachelor's Degree in a clinical or life science field, business, or healthcare operations. A degree must be obtained through an accredited institution. Education is verified.
+ Two (2) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures.
**OR**
+ Three (3) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures.
**Preferred Qualifications**
+ Experience in clinical research setting, including relevant study management experience. · Experience in a healthcare or hospital setting.
**Location:**
Intermountain Health Intermountain Medical Center
**Work City:**
Murray
**Work State:**
Utah
**Scheduled Weekly Hours:**
40
The hourly range for this position is listed below. Actual hourly rate dependent upon experience.
$27.65 - $43.55
We care about your well-being - mind, body, and spirit - which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged.
Learn more about our comprehensive benefits package here (***************************************************** .
Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
At Intermountain Health, we use the artificial intelligence ("AI") platform, HiredScore to improve your job application experience. HiredScore helps match your skills and experiences to the best jobs for you. While HiredScore assists in reviewing applications, all final decisions are made by Intermountain personnel to ensure fairness. We protect your privacy and follow strict data protection rules. Your information is safe and used only for recruitment. Thank you for considering a career with us and experiencing our AI-enhanced recruitment process.
All positions subject to close without notice.
Clinical Research Coordinator
Clinical research associate job in Lafayette, LA
We are seeking a dedicated and detail-oriented Clinical Research Coordinator to join our team (RN or LPN)
In this role, you will be responsible for overseeing clinical trials and ensuring compliance with regulatory standards. You will work closely with research teams, participants, and sponsors to facilitate the successful execution of clinical studies. The ideal candidate will possess a strong understanding of medical terminology, data management systems, and compliance management.
Responsibilities
Coordinate and manage all aspects of clinical trials from initiation to completion.
Conduct blood sampling and ensure adherence to safety standards.
Oversee data collection processes, ensuring accuracy and integrity of data.
Review documentation for compliance with regulatory requirements and study protocols.
Maintain up-to-date knowledge of HIPAA regulations and ensure participant confidentiality.
Collaborate with investigators to develop study protocols and informed consent documents.
Monitor trial progress, addressing any issues that arise during the study.
Prepare reports on study findings and assist in the publication of results.
Requirements
Nursing degree in a relevant field (e.g., life sciences, nursing).- Recommended not preferred
Experience in clinical development or related field preferred.
Strong knowledge of medical terminology and clinical research practices.
Proficiency in data management systems and documentation review processes.
Excellent organizational skills with attention to detail.
Ability to work independently as well as part of a team.
Strong communication skills, both verbal and written.
Familiarity with compliance management practices in clinical research.
Join us in advancing medical knowledge through rigorous research while ensuring the highest standards of participant care and data integrity.
Benefits:
401(k)
Dental insurance
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Retirement plan
Vision insurance
Medical Specialty - Urology
Schedule:
8 hour shift
Day shift
Monday to Friday
No nights
No weekends
Education:
Valid Nursing License for Louisiana
Experience:
Data management: 3 years (Required)
Medical terminology: 3 years (Required)
Work Location: In person
Auto-ApplyClinical Research Coordinator
Clinical research associate job in Tupelo, MS
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research 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.
Clinical Research Coordinator I
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research 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 Clinical Research Coordinator (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 clinical research 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.
Auto-ApplyClinical Research Coordinator
Clinical research associate job in Tupelo, MS
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research 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.
Clinical Research Coordinator I
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research 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 Clinical Research Coordinator (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 clinical research 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.
Auto-ApplyClinical Coordinator - Green Clinic
Clinical research associate job in Ruston, LA
Job Description
The Clinical Coordinator will assist the Director of Nursing in the planning, development, financial and staff activities of the Clinics. Complies with organization, department and regulatory standards. Plans the management of staff and ensures sound fiscal operations. Position provides direction, support and guidance to the clinical staff in their development both clinically and professionally. Strong leadership and management skills required.
LPN License Required
Job Posted by ApplicantPro
Surgical Technology - Clinical Coordinator
Clinical research associate job in Shreveport, LA
Careers at SUSLA The Clinical Coordinator must be responsible for the organization, administration, continuous review, planning, development, and general effectiveness of clinical experiences for students enrolled in the Surgical Technology program.
RESPONSIBILITIES
* Assist in meeting program goals in conjunction with the Program Director and other clinical instructors, which are consistent with the goals of the Division of Allied Health Sciences and Nursing and the University.
* Responsible for students attaining the objectives for each didactic or clinical rotation.
* Provide student evaluation on a recurrent basis and with sufficient frequency to provide both the student and program faculty with valid and timely indications of the student's progress.
* Assist the students in the achievement of the competencies and learning domains stated in the curriculum.
* When in clinical, provide direction and guidance to clinical preceptors.
* Advise students on academic and professional aspects of the program and performance.
* Maintain professional expertise.
* Communicate with Program Director on all issues related to students and clinical sites
* Coordinate clinical assignments of both students and faculty
* Ensure that students and faculty adhere to the clinical site's required documentation and maintain health records.
REQUIRED EDUCATION AND EXPERIENCE:
* Has a minimum of 3 years of experience in the ST scrub role, as an ST instructor, or both within the last five years.
* Holds current CST, CSFA, or CST/CSFA (NBSTSA Certification).
* Possess a minimum of an Associate Degree.
PREFERRED QUALIFICATIONS:
* Associate Degree in Surgical Technology and/or higher with strong experience in the scrub role in the operating room.
* Exhibits leadership attributes.
TYPE: Full-time
COMPENSATION: $51,000-$51,678
APPLICATION DEADLINE: Review of applications begins January 5, 2026 and continues until position is filled.
* The application can be filled out online at SUSLA's Application for Employment
* Please attach cover letter, resume, transcript(s), and three references to application.
* Reasonable accommodations may be made to enable individuals with disabilities to perform the duties.
APPLY NOW ➔
Reasonable accommodations may be made to enable individuals with disabilities to perform the duties.
Criminal background check and reference verification is required.
Southern University at Shreveport, an institution within the Southern University and A & M System, seeks to provide quality education for its students, while being committed to the total community. This institution prepares students for careers in technical and occupational fields; awards certificates, diplomas and associate degrees; and offers courses and programs that are transferable to other colleges and universities. Dedicated to excellence in instruction and community service, this open enrollment institution promotes cultural diversity, provides developmental and continuing education, and seeks partnerships with business and industry.
Title IX is a federal law that prohibits discrimination on the basis of sex in any federally funded education program or activity. Title IX prohibits use of federal money to support sex discrimination in education programs and provides individuals protection against such practices.
In compliance with federal law and USDOE federal guidance, including provisions of Title VII of the Civil Rights Act of 1964 (Title VII), Title IX of the Education Amendments of 1972 (Title IX), Section 503 and 504 of the Rehabilitation Act of 1973, the Americans with Disabilities Act (ADA) of 1990, the ADA Amendments Act of 2008, the Age Discrimination in Employment Act of 1967 (ADEA), Executive Order 11246, Executive Order 13988, the Vietnam Era Veterans Readjustment Assistance Act of 1974 as mended by the Jobs for Veterans Act, the Uniformed Services Employment and Reemployment Rights Act, as amended, and the Genetic Information Nondiscrimination Act of 2008, an institution of the Southern University System shall not discriminate against individuals on the basis of their race, sex, sexual orientation, gender identity, gender expression, religion, color, nation or ethnic origin, age, disability, military service, covered veteran's status, or genetic information in its administration of education policies, programs, or activities; admission policies; scholarship and loan programs; athletic or other institution-administered programs; or employment.
As part of their commitment to maintaining a community free of discrimination, and in compliance with Title IX's mandate, institutions of the Southern University System shall address allegations of power-based violence and sexual misconduct, including sexual harassment and sexual assault, in a timely and effective manner. Further, institutions of the Southern University System will provide resources as needed for affected persons (Reporters, Complainants, Respondents, and third parties within the institution's community) and will not tolerate retaliation against any person who reports or participates in the investigation of alleged power-based violence or sex/gender discrimination.
In accordance with the requirement of Title II of the Americans with Disabilities Act of 1990 and its Amending Act of 2008 (collectively "ADA"), the Southern University System (System) will not discriminate against qualified individuals with disabilities on the basis of disability in its services, programs, or activities. The System does not discriminate on the basis of disability in its hiring or employment practices and complies with all regulations promulgated by the U.S. Equal Employment Opportunity Commission under Title I of the ADA. The System will generally, upon request, provide appropriate aids and services leading to effective communication for qualified persons with disabilities so they can participate equally in the System's programs, services, and activities, including qualified sign language interpreters, assistive listening devices, documents in Braille, and other ways of making communications accessible to people who have speech, hearing, or vision impairments. The System will make reasonable modifications to policies, procedures, and programs to ensure that people with disabilities have an equal opportunity to enjoy all of its programs, services, and activities. Anyone who requires an auxiliary aid or service for effective communication, or a modification of policies or procedures to participate in a program, service, or activity of the System, should contact the ADA Coordinator. The ADA does not require the System to take any action that would fundamentally alter the natures of its programs or services or impose an undue financial or administrative burden. Complaints that a program, service, or activity of the System is not accessible to persons with disabilities should be directed to the ADA Coordinator.
Clinical Research Associate II
Clinical research associate job in New Orleans, LA
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1 -2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi -task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self -motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
Clinical Research Coordinator II
Clinical research associate job in New Orleans, LA
The primary responsibility of the Clinical Research Coordinator II is to coordinate and conduct the day-to-day operation of clinical trials and other epidemiological studies. The Clinical Research Coordinator II is required to have knowledge of protocol requirements and good clinical practices as set forth by federal regulations. The Clinical Research Coordinator II is able to recruit, follow, and retain study participants, and perform study visits, data collection and entry, and quality control activities according to study protocol independently. The Clinical Research Coordinator II is also able to perform procedures required by the study protocol(s), such as blood pressure measurements, EKD, and laboratory processing. The Clinical Research Coordinator II is responsible for all data and source documentation, adverse event reporting and maintenance of complete regulatory files, under direct supervision.• Knowledge of good clinical research practice is required
* Must be able to interact well with patients and the general public
* Excellent organization, analytical, interpersonal, and communication skills
* Ability to maintain confidentiality in all work performed
* Proficient in various software programs (including database management [e.g. Access], presentation packages [e.g. PowerPoint], spreadsheets [e.g. Excel], and advanced word processing [e.g. Word]).
* Ability to acquire and maintain all required CITI training certificates
* Ability to acquire and maintain credentialing at all required institutions: Tulane Medical Center, Veterans Administration Hospital/New Orleans, LA and University Medical Center.
REQUIRED BACKGROUND CHECK, PHYSICAL, AND DRUG SCREENING FOR INCUMBENTS WHO HAVE CONTACT OR EXPOSURE TO ANIMALS OR ANIMAL TISSUES:
Selected candidates must complete and pass a background check and an occupational health screening as a condition of employment. For identified jobs, a drug screening will also be required. The background investigation, required occupational health screening, and any required drug screening will be conducted after a conditional employment offer has been extended.• Bachelor's Degree or RN with current state licensure at the time of hire and one (1) year of related work experience;
OR
* LPN with current state licensure at the time of hire and four (4) years of related work experience;
OR
* A Master's Degree in a related field• Knowledge of IRB submission process and requirements.
* Knowledge of good clinical practices as set forth by federal regulations.
Clinical Research Coordinator
Clinical research associate job in Lafayette, LA
Job Description
We are seeking a dedicated and detail-oriented Clinical Research Coordinator to join our team (RN or LPN)
In this role, you will be responsible for overseeing clinical trials and ensuring compliance with regulatory standards. You will work closely with research teams, participants, and sponsors to facilitate the successful execution of clinical studies. The ideal candidate will possess a strong understanding of medical terminology, data management systems, and compliance management.
Responsibilities
Coordinate and manage all aspects of clinical trials from initiation to completion.
Conduct blood sampling and ensure adherence to safety standards.
Oversee data collection processes, ensuring accuracy and integrity of data.
Review documentation for compliance with regulatory requirements and study protocols.
Maintain up-to-date knowledge of HIPAA regulations and ensure participant confidentiality.
Collaborate with investigators to develop study protocols and informed consent documents.
Monitor trial progress, addressing any issues that arise during the study.
Prepare reports on study findings and assist in the publication of results.
Requirements
Nursing degree in a relevant field (e.g., life sciences, nursing).- Recommended not preferred
Experience in clinical development or related field preferred.
Strong knowledge of medical terminology and clinical research practices.
Proficiency in data management systems and documentation review processes.
Excellent organizational skills with attention to detail.
Ability to work independently as well as part of a team.
Strong communication skills, both verbal and written.
Familiarity with compliance management practices in clinical research.
Join us in advancing medical knowledge through rigorous research while ensuring the highest standards of participant care and data integrity.
Benefits:
401(k)
Dental insurance
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Retirement plan
Vision insurance
Medical Specialty - Urology
Schedule:
8 hour shift
Day shift
Monday to Friday
No nights
No weekends
Education:
Valid Nursing License for Louisiana
Experience:
Data management: 3 years (Required)
Medical terminology: 3 years (Required)
Work Location: In person
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Clinical Research Coordinator
Clinical research associate job in Flowood, MS
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research 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.
Clinical Research Coordinator I
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research 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 Clinical Research Coordinator (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 clinical research 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.
Auto-ApplyClinical Research Coordinator
Clinical research associate job in Flowood, MS
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research 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.
Clinical Research Coordinator I
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research 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 Clinical Research Coordinator (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 clinical research 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.
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