Senior Clinical Research Coordinator
Clinical research coordinator job in New Orleans, LA
3-5 Must-Have Qualifications
3-5 years of experience as a Lead Clinical Research Coordinator (site management experience a plus).
Experience running complex protocols independently (SSU → Closeout).
Ability to perform all regulatory responsibilities for a study, including IRB, logs, and ISF.
Full proficiency managing studies without hand-holding; cannot depend on others for regulatory or operational processes.
Phlebotomy experience required.
Must work fully onsite Monday-Friday, 9-5 (future hybrid possible after demonstrated success).
Lead Clinical Research Coordinator (CRC) / Future Clinical Research Manager
Location: Onsite, M-F 9AM-5PM
Department: Clinical Research
Reports To: Site Leadership & Principal Investigator
Status: Full-Time, Onsite Only
Overview
We are seeking a highly experienced Lead Clinical Research Coordinator (CRC) who is ready to step into a hybrid role combining hands-on clinical trial execution with growing leadership responsibilities. This individual will serve as the backbone of a new clinical research department, functioning as the only CRC on-site initially, with a clear pathway to build, train, and manage a research team as the program expands.
This is a career-defining role for a CRC who wants to transition into management, site leadership, and future operational oversight.
What This Role Looks Like Day-to-Day
Morning Responsibilities
Prepare for participant visits, ensuring all required documents, eSource, and study materials are ready.
Build new eSource templates when needed.
Greet participants, conduct study visits, review protocols, and perform hands-on clinical procedures (including phlebotomy).
Serve as the primary point of contact for all participant communication, questions, and study support.
Throughout the Day
Independently manage trial operations from startup through closeout.
Maintain compliance with FDA, ICH-GCP, and internal SOPs.
Organize and maintain regulatory files, source documents, and study logs.
Actively recruit study participants through EMR searches and site-driven strategies.
Educate physicians and clinic staff on research processes (e.g., lunch-and-learns).
Ensure high-quality documentation and readiness for audits or monitoring visits.
Afternoon Responsibilities
Work directly with a research-naïve Principal Investigator, guiding them through study conduct and research standards.
Begin taking on leadership responsibilities as the department grows:
Training and onboarding new CRCs
Delegating tasks and managing workload distribution
Performing internal QC checks
Conduct detailed reviews of data, regulatory files, and eSource to ensure completeness and inspection readiness.
End of Day
Log progress and visit documentation in the CTMS (CRIO).
Manage study supplies, investigational products, shipments, and inventory.
Participate in meetings with sponsors, CROs, and site leadership.
Prepare for upcoming audits, interim monitoring visits, and SIVs.
Over time, take on advanced responsibilities including budget review, contract support, and financial reconciliation
Clinical Research Associate II
Clinical research coordinator 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 Associate / Senior Clinical Research Associate - Oncology - US - FSP
Clinical research coordinator job in Baton Rouge, LA
**Job Purpose:** The Senior Clinical Research Associate I (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.
Senior Clinical Research Coordinator
Clinical research coordinator job in Louisiana
About the Role
Culmen International is hiring a qualified Senior Clinical Research Coordinator in Laos to provide scientific and technical services to an international Department of Defense medical contract.
The objective of this contract is to provide clinical site management and in-country clinical research operations and scientific laboratory support for surveillance, epidemiology, and intervention studies, sample collection, and laboratory testing in field sites located across Southeast Asia. This effort is a cooperative and collaborative project involving committed partner countries to include the United States.
What You'll Do in Your New Role
Assists Clinical Investigators in planning and execution of research studies.
Manages the regulatory documents and prepare study files for inspections and audits.
Serves as liaison between government leads and collaborators, sponsor, auditors, and ethical review committee.
Prepares study documents that serve as source documents for the study.
Screens subjects for eligibility to participate in research protocols, enroll subjects and obtain informed consent.
Assists Clinical Investigators in performing study and other procedures as required.
Schedules and performs follow-up visits with study subjects.
Checks and reviews data for any discrepancies recorded on Case Report Forms and electronic CRFs.
Ensures that studies are conducted in accordance with approved protocols, institutional regulatory requirements, SOP, SSPs, Good Clinical Practice (GCP) guidelines, sponsor guidelines and other regulatory requirements as applicable.
Supervise the development of Standard Operating Procedures (SOPs) and Study Specific Procedures (SSPs) to standardize the approach to the conduct of the study by collaborative study personnel;
Comply with quality assurance/quality control guidance from the Department's Quality Control Unit and authorized internal/external auditors.
Assists Clinical Investigators in performing study and other procedures as required.
Coordinate and support the development of the technology solutions and mapping.
Assists database management staff in any computer related concerns;
Ensure quality data entry so as to perform accurate statistical analysis for data distribution and publication;
Prepare periodic study reports and presentations as required.
Coordinates the procurement, acquisition, shipment and distribution of supplies and equipment needed on-site
Required Qualifications
Bachelor's degree in a relevant field such as clinical research administration, nursing, public health or biology.
Certified Clinical Research Coordinator
Fluent in English.
About the Company
TALENT PIPELINE - Qualified applicants will be contacted as soon as funding for this position is secured!
Culmen International is committed to enhancing international safety and security, strengthening homeland defense, advancing humanitarian missions, and optimizing government operations. With experience in over 150 countries, Culmen supports our clients to accomplish critical missions in challenging environments.
To learn more about Culmen International, please visit **************
At Culmen International, we are committed to creating and sustaining a workplace that upholds the principles of Equal Employment Opportunity (EEO). We believe in the importance of fair treatment and equal access to opportunities for all employees and applicants. Our commitment to these principles is unwavering across all our operations worldwide.
Auto-ApplySpecialist, Clinical Business Operations, Oncology
Clinical research coordinator 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.
**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_
CLINICAL TRIALS COORDINATOR 1, 2 or 3
Clinical research coordinator job in Baton Rouge, LA
Under supervision, the Clinical Trials Coordinator (CTC) will attend clinic and assist the Principal Investigator and Research RN's with NIH grant funded, industry sponsored, or investigator-driven clinical trials in-person and virtually. The CTC will assist the LSUHSC Stanley S. Scott Cancer Center (SSSCC) clinical trial team's Principal Investigators, research RN's, and other Clinical Trial Coordinators with NIH grant-funded and investigator-driven clinical trials. The CTC will also provide support and patient follow-up visits on all NCI and pharmaceutical sponsored studies associated with the SSSCC, the Genitourinary Oncology team, and its partner institutions.
The CTC is responsible for travel to/from and attending clinic, providing informed consent, data entry, ordering study supplies, patient scheduling related to clinical studies/trials, patient follow-up, and other duties as is appropriate for the position's level.
Clinical Study Coordinator
Clinical research coordinator job in Lafayette, LA
Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.
As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.
Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.
Summary:
The Clinical Study Coordinator carries out assigned tasks associated with the collection, documentation, and maintenance of clinical data. Work closely with Clinical Research Coordinators and assist them in the conduct of the clinical research protocols.
Responsibilities
Duties/Responsibilities:
Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs
Communicate effectively and professionally with coworkers, leadership, study subjects,sponsors, CROs, and vendors
Apply good documentation practices when collecting and correcting data, transferring data tosponsor/CRO data capture systems and resolving queries
Maintain confidentiality of patient protected health information, sponsor confidentialinformation and Velocity confidential information
Assist in ensuring patient safety is upheld and all adverse events, serious adverse events, andadverse events of special interest are followed and reported in accordance with the protocol and Velocity SOPs
Assist in ensuring all data is entered into the sponsor's and/or vendor's data portal and all queries are resolved in a timely manner
Assist in ensuring staff are delegated and trained appropriately and training is accurately documented
Perform clinical duties (e.g. drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope of the protocol and local law and regulations.
Promote respect for cultural diversity and conventions with all individuals.
Other duties as assigned
Qualifications
Education/Experience:
Associate's degree OR
High School Graduate and/or technical degree with minimum of 1 year relevant experience in the life science industry
Required Licenses/Certifications:
Phlebotomy if applicable and required by state law
Intramuscular dose administration and preparation if applicable and required by state law
Required Skills:
Demonstrated knowledge of medical terminology
Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
Basic ability to work in a fast-paced environment
Demonstrated verbal, written, and organizational skills
Demonstrated interpersonal and communication skills
Demonstrated ability to work as a team player
Demonstrated ability to read, write, and speak English
Basic ability to multi-task
Demonstrated ability to follow written guidelines
Basic ability to work independently, plan and prioritize with some guidance
Basic ability to be flexible/adapt as daily schedule may change rapidly
Must be detail oriented
Demonstrated ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued and/or praised.
Required Physical Abilities:
Sit or stand for long periods of time
Travel locally
Communicate in person and by a telephone
Limited walking required
Limited to lifting up to 30 pounds
NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Auto-ApplyResearch Coordinator
Clinical research coordinator job in New Orleans, LA
The Department of Epidemiology is looking for a Research Coordinator. The Research Coordinator is responsible for the analysis and quality assurance of data from various studies and for providing monthly statistics. This individual will assist the Program Manager is training and supervising students and staff and for assisting the Program manager with IRB submissions. This position may also perform administrative and coordinative work directed toward the design, implementation, evaluation and review of the assign assigned project(s). This person will also assist the Outreach Coordinator in engaging and working with community partners and will assist in recruitment and enrollment and interface with the Marketing Consultant. Responsibilities include working occasional weekend and evening events, which allows flexibility for hours during the work week and coordination with other members of the team. This position may require frequent travel between primary locations (assigned community organizations and Tulane University) and other study partners.• Knowledge of and competence in the technical skills needed to support study teams with conducting quantifiable, meaningful research.
* Excellent oral, written, and interpersonal communication skills.
* Ability to interact with individuals of diverse backgrounds at all levels internal and external to the organization.
* Ability to work collaboratively as a positive, contributing member of a team.
* Ability to utilize MS Office programs, Access, Excel and various other software programs is required.
* Ability to manage multiple tasks and projects simultaneously.
* Ability to prioritize work, performing assignments with minimal supervision.
* Research and/or data collection experience.
* Knowledge of community resources and experience working with a variety of community-based organizations preferred.
* Ability to acquire and maintain all required CITI training certificates and certification needed for the research study.
* Bachelor's Degree in public health, epidemiology, or related field.
* 2 years of related experience.
* Master's Degree in public health, epidemiology, or related field.
* Work experience in an academic environment.
* Familiarity with epidemiological research, including clinical trials.
* High proficiency with full Microsoft applications; relational data-base management software systems experience and SAS.
* Review and respond to queries to address problematic data identified during data review activities; apply proper correction/modification.
Applied Research Coordinator
Clinical research coordinator 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 coordinator 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-ApplyResearch Husbandry Coordinator, Pre-Clinical
Clinical research coordinator job in New Iberia, LA
Research Husbandry Coordinator, Pre-Clinical Department: 9010|NIRC Administration Responsibilities: The Research Husbandry Coordinator, Pre-Clinical plays a critical leadership role in overseeing animal housing, husbandry practices, and husbandry related research support activities at the New Iberia Research Center. This position manages housing allocations, ensures compliance with regulatory and institutional requirements, and supports study directors and principal investigators in the execution of biomedical research involving nonhuman primates (NHPs). The coordinator ensures that all husbandry activities are conducted in accordance with the Animal Welfare Act, FDA Good Laboratory Practices, Institutional Biosafety Committee (IBC) approvals, and NIRC Standard Operating Procedures.
Key Responsibilities
* Manage space allocation of indoor housing and oversee scheduling of daily protocol-mandated tasks (e.g., fasting periods, special diets, feeding intervals).
* Track and schedule contract-driven and regulatory-mandated animal health testing, including TB testing, body weight measurement, veterinary physicals, and serological testing.
* Consult during study design, development, and implementation to ensure adherence to research timelines, including relocation of NHPs from outdoor to indoor housing.
* Work with Study Directors/Principal Investigators to isolate infectious studies according to agent, transmission mode, and approved biosafety levels.
* Update and maintain indoor housing placement diagrams to support daily census, veterinary monitoring, behavioral management, and compliance with the Animal Welfare Act.
* Provide directives to Animal Resources personnel to maintain housing in compliance with SOPs, IACUC approvals, IBC directives, and Radiation Safety approvals.
* Assess complex living environments and animal behaviors to ensure optimal welfare during in-life studies; troubleshoot and resolve potential failures promptly.
* Oversee transfer of NHPs to and from biomedical research facilities, including initiating USDA-certified transporter bids and managing preconditioning, diagnostic, and prophylactic schedules.
* Ensure compliance with all applicable federal, state, and institutional regulations governing the use of NHPs in biomedical research.
* Demonstrate flexibility to multitask and adapt to changing daily needs and priorities at NIRC.
Qualifications:
Required Qualifications:
* Bachelor of Science degree or related field with scientific emphasis
* OR 5 years of relevant experience in a contract research setting, assisting in conduct of research protocols may be substituted for the degree.
* 10 years of relevant experience in a research facility as a lead worker, supervisor, and project lead (or equivalent) utilizing non-human primate animal models
Preferred Qualifications:
* AALAS Technician certification
Skills, Abilities, Etc.:
* Advance knowledge in a field of science and relevant experience to independently conduct protocol mandated research procedures in nonhuman primate animal studies in an AAALAC-accredited facility
Job Ad# (req4357)
Clinical Research Associate 1
Clinical research coordinator 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 - West Coast - Oncology - FSP
Clinical research coordinator job in Baton Rouge, LA
The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA 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 SrCRA 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 SrCRA 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 ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel.
A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD.
**Key Accountabilities:**
**Site Management Responsibilities**
+ Contributes to the selection of potential investigators.
+ In some countries, as required, SrCRAs 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 always inspection ready.
+ 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 ICHGCP, 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 Scientific Liaisons (MSLs) as directed by LSAD or line manager
**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 (Desirable):**
+ 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 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-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.
RN CLINICAL TRIALS COORDINATOR 3
Clinical research coordinator job in Baton Rouge, LA
The LSU Cancer Center is seeking an RN Clinical Trials Coordinator 3 (RN CTC3) to coordinate, manage, and assist physicians in enrolling and monitoring patients on all drug-industry sponsored and the NCI-funded clinical trials. The RN CTC3 will recruit, enroll, administer care, and provide patient follow-up visits in-person and virtually on all NCI and pharmaceutical sponsored studies associated with the Cancer Center, the Genitourinary Oncology team, Gynecologic Oncology team, and its partner institutions. The RN CTC3 will also work with the Virtual Research clinical trials program which offers specialized care to female patients which would otherwise be unattainable for most women in Louisiana.
Duties will include: attending oncology clinics in-person and virtually to collaborate with physicians to determine patient eligibility; informing and educating the patient and their families about a particular study; providing informed consent; scheduling regular appointments and follow-up as needed; providing treatment; obtaining study specific lab-work; evaluating and monitoring effects of treatment; organizing, collecting and managing data; submitting forms and reports as required; working closely with monitors from the drug companies to ensure protocols are being implemented correctly and that the necessary clinical data is being captured; processing and packaging specimens for mail-out. The RN CTC3 will work with physicians in-person and virtually at LSUHSC clinics, various satellite locations, and with our partner institutions.
Clinical Research Coordinator II
Clinical research coordinator job in New Orleans, LA
The primary responsibility of the Clinical Research Coordinator II is to manage all aspects of conducting clinical trials. The Clinical Research Coordinator II is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As one of the primary resources for the protocol, the Clinical Research Coordinator II acts as a liaison between the patient, investigator, Institutional Review Board and sponsor. The Clinical Research Coordinator II is able to screen, enroll and follow study patients, under supervision, ensuring protocol compliance and close patient monitoring, continuing the required learning process record in this second level position for advancement towards a Clinical Research Coordinator III position. The Clinical Research Coordinator 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
* 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.
* Bachelor's degree or RN with current Louisiana state licensure at the time of hire and one (1) year of related work experience
OR
* LPN with current Louisiana state licensure at the time of hire and four (4) years of related work experience
* Knowledge of IRB submission process and requirements
* Knowledge of good clinical practices as set forth by federal regulations
Sr. Clinical Research Associate - FSP
Clinical research coordinator job in Baton Rouge, LA
**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research 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.
RN CLINICAL TRIALS COORDINATOR 1, 2 or 3
Clinical research coordinator job in Baton Rouge, LA
The LSU Health, School of Medicine in New Orleans is accepting applications for an RN Clinical Trials Coordinator 1, 2 or 3. This position will function with a high level of independence, working with the Department of Surgery under the direction of the study investigators.
The position requires the skills and training of a registered nurse with clinical nursing skills and extensive clinical research experience.
The RN Clinical Trials Coordinator 1, 2 or 3 will be accountable for the research administration, testing, monitoring, and evaluation of research patients along with regulatory submissions within the research operations.
Clinical Research Coordinator II
Clinical research coordinator job in New Orleans, LA
The Clinical Research Coordinator II will coordinate and conduct the day-to-day operations of TRIAD ongoing studies in cardiovascular diseases. The Clinical Research Coordinator II 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 protocols, the Clinical Research Coordinator acts as a liaison between the patient, investigator, Institutional Review Board and sponsor. The Clinical Research Coordinator II screens, enrolls and follows study patients, ensuring protocol compliance, and effective monitoring of clinical trial subjects. The Clinical Research Coordinator II is also responsible for all data and source documentation, adverse event reporting and maintenance of complete regulatory files.• Proven ability to oversee day-to-day operations of clinical trials including their respective regulatory and administrative processes including informed consent, eligibility review, protocol implementation, IRB approval, DSMP, and event reporting
* Experience supervising and training research staff, including organizing, prioritizing, and scheduling work assignments in a medical setting.
* Willingness to travel to visit trial clinic sites
* Flexibility to work evenings and weekends, as needed, and to be available to respond promptly to all communications from study participants, trial clinical research coordinators, and clinic staff on for emergency situations or answer questions
* In-depth knowledge of federal regulations pertaining to Good Clinical Practice and conducting clinical trials set forth in the Code of Federal Regulations
* In-depth knowledge of IRB submission process and requirements as well as regulatory documentation
* 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
* Ability to perform, manage, and balance multiple projects and tasks simultaneously, work under time constraints, and meet deadlines
* 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, including Tulane Medical Center and all Federally-Qualified Health Centers included in the trial
* 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, ensure participants are contacted at the correct date and time for the conduct of study assessments
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 in public health or other science area 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
* 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.
COMMUNITY RESEARCH COORDINATOR
Clinical research coordinator job in Baton Rouge, LA
The LSU LCMC Health Cancer Center, Community Outreach & Engagement (COE) Office is seeking a dynamic, collaborative and experienced public health professional to serve as the Community Research Coordinator. COE is dedicated to reducing the burden of cancer through prevention, screening, and survivorship programs and initiatives that are informed by research and developed through community engagement. This position is funded by the LSU LCMC Health Cancer Center.
Under the general supervision of the Community Outreach & Engagement Manager, this position will lead state-wide community engagement efforts for the COE office. Key duties include but are not limited to: engaging multi-sector partners across the state to identify community research opportunities; developing state-wide community research strategies; identifying and coordinating COE community science activities; training researchers and facilitating their community engagement activities; working with researchers to translate and disseminate cancer research findings to community members; and managing data systems for tracking community science opportunities, activities, and findings.
Clinical Research Coordinator II
Clinical research coordinator job in New Orleans, LA
Coordinates all study-related and regulatory processes for the Tulane Cancer Center Office of Clinical Research (TCC OCR) and affiliate sites under the overall direction of the Director of the Clinical Research Office. Responsible for coordinating current and future Oncology research projects. Responsible for data collection and management and compliance with federal and IRB regulatory policies.
1. Excellent written and verbal communication.
2. Excellent computer literacy skills, including knowledge of standard office software.
1. Bachelor's Degree or RN with current LA licensure at the time of hire.
2. Two years clinical research experience.
1. Master's degree in Public Health, Business or Social work preferred.