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
Senior Clinical Research Coordinator/Sr. DHS - Alabama 10.3.25
Clinical research coordinator job in Alabama
About N-Power MedicineN-Power Medicine aims to establish a new paradigm in drug development by reinventing the ‘how' and transforming clinical trials through better integration with clinical practice, ensuring broader participation by physicians and patients. We are building an exceptional multi-disciplinary team with diverse expertise spanning healthcare, engineering, technology and regulatory, and with people who share our core value of Empowering Community through generosity, curiosity and humility. We are working with urgency to bring better therapies to patients faster.
Position OverviewYou will be a part of the rapidly changing clinical oncology environment with the opportunity to impact the future of clinical research and improve patients' lives while growing professionally at a dynamic, fast-growing, start-up organization. As the Senior Digital Health Specialist, you will work at a clinical site in Tuscaloosa and/or Anniston, Alabama. This role would act as a site liaison between NPM staff and the network partner to address any issues or concerns in real time.
The ideal candidate has extensive clinical oncology research experience or research experience in a healthcare setting. You are an expert in your understanding of clinical workflow, patient data systems and clinical research in an oncology setting. In collaboration with the Digital Health Specialist Manager, you will be vital to the successful implementation and operations with Network Partners and serve as point of contact for local N-Power Medicine staff. We are looking for individuals who are motivated and ambitious professionals who desire to positively influence and innovate upon the quality of care for patients diagnosed with cancer.
Role Objectives and Responsibilities
-Serve as the Company's trusted face to the clinical practice, providing clinical support while advancing research data collection.-Act as the point of contact for network partners and N-Power Medicine staff supporting the site to address queries and issues in a timely manner.-Participate directly in the implementation at the site and all aspects of a site start-up. -Support the hiring and onboarding of new N-Power Medicine staff including, new hire interviews, new hire training, onsite shadowing, etc.-Perform quality assurance activities as required, identify opportunities for retraining of Digital Health Staff.-Assist in developing training, work instructions and standard operating procedures, and other materials.-Manage queries regarding missing, aberrant, or potential outlier data for studies and projects - escalate to the healthcare provider and Digital Health staff as necessary for resolution.-Obtain informed consent for N-Power Medicine's clinical trials. -Assist and participate in the site clinical trial initiation and clinical trial(s) activities as assigned.-Ensure adherence to study protocols, data completeness and patient consent.-Lead patient recruitment strategies where appropriate as site liaison and network partner research department. -Foster collaborative relationships by effectively communicating with clinical site staff, internal stakeholders, and N-Power Medicine.-Attend, participate and take action in required meetings.-Build and maintain relationships at the clinical site, becoming part of the functional team of practitioners.-Ensure quality and integrity of the Kaleido Registry and clinical trials data, protocol compliance and confidentiality with N-Power Medicine's and site's policies, standard operating procedures (SOPs), and Good Clinical Practice (GCP).-Collect practice insights regarding Kaleido Registry workflows and maintain site performance metrics for internal and site reporting. -Provide proactive input and user experiences including software- escalate issues while offering solutions based upon your expert knowledge and experience. -Solicit feedback from users of new technology and contribute to implementation for clinical care and clinical trials. -Additional duties and responsibilities as required.
Education, Experience, Behavioral Competencies, & Skills-5+ years of experience in oncology clinical research and/or oncology ambulatory care -Bachelor's degree, focused in health science or related field -Clinical supervisory or management experience preferred-Certified Clinical Research Coordinator, Associate or Professional (CCRC, CCRA or CCRP) preferred-Bilingual in Spanish (or other language) is preferred-In depth knowledge of clinical trials, study-specific operating procedures and patient consent forms-Strong desire to drive a paradigm change in clinical research conduct and improve patients' lives-Compassionate focused patient care-Coach and encourages other team members, contributing to a positive team environment-Self-starter, able to work independently, prioritize actively, seek input, and problem solve in complex and fast-evolving environments-Results oriented focused on delivering the goals set-forth-Attention to detail and strong organizational skills-Exceptional oral and written communication skills with a proven ability to lead through effective interpersonal interactions at all organizational levels-Critical thinking and proven problem-solving skills-Work hours are dependent on local Network Partner Clinics (typically M-F, 8-5pm)-Generous, curious and humble.
Travel Requirements Daily travel between network partner sites may be required
Pay InformationThe expected salary range for this position is $118,000 and $177,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. N-Power Medicine (NPM) offers equity at hire as well as a discretionary annual bonus which may be available based on Company performance. This position is eligible for company benefits.
More About Us:We are a mission-driven, well-funded, rapidly growing company, eager to attract passionate professionals offering a highly attractive compensation package with a balanced and flexible work environment, competitive industry benefits as well as a 401K plan and other great company “perks.”
We are an Equal Opportunity Employer and value diversity at our company. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Covid-19 Policy - The Company is committed to providing and maintaining a safe workplace, and to safeguard the health and well-being of our employees, families, visitors, and the community. While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary. We currently do not have mandatory COVID-19 vaccination requirements for our employees and contractors, as the COVID-19 public health emergency has ended. However, there are certain N-Power Medicine employees and contractors who, based on their role, will be required to continue to follow our 2021 COVID-19 vaccination and other requirements as mandated by N-Power Medicine's partners they serve. We reserve the right to modify or amend our corporate policy at any time.
Applicants must be currently authorized to work in the U.S. on a full-time basis. The Company will not sponsor applicants for work visas.
Please note that state-specific background checks and screenings may be required for this role. Employment is contingent upon successfully passing all applicable screenings.
Notice on fraudulent job offers: Only positions posted on ****************************************** site are legitimate. Please be mindful of recruitment fraud and job scams. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Auto-ApplyClinical Research Coordinator
Clinical research coordinator job in Birmingham, AL
Gastro Health is seeking a Full-Time Clinical Research Coordinator to join our team!
Gastro Health is a great place to work and advance in your career. You'll find a collaborative team of coworkers and providers, as well as consistent hours.
This role offers:
A great work/life balance
No weekends or evenings - Monday thru Friday
Paid holidays and paid time off
Rapidity growing team with opportunities for advancement
Competitive compensation
Benefits package
Duties you will be responsible for:
General Administrative
Coordinates with Principal Investigator, local site, and Central Hub to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures.
Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
Assists Principal Investigator to assure that all key personnel or persons ‘engaged' in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
Cooperates with compliance and monitoring efforts related to sponsored program administration and respond to any audit findings and implement approved recommendations.
Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors.
Protocol Preparation & Review
Attends investigator meetings as required or requested by the PI.
Collaborates with the Regulatory Specialist to prepare IRB and any other regulatory submission documents as required by the protocol.
Prepares other study materials as requested necessary. These study materials include, but are not limited to, the informed consent document, source documents, enrollment logs, and drug/device accountability logs.
Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
Conduct of Research
Reviews and comprehends the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
Develops and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.
Conducts or participates in the informed consent process and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
Registers each participant in CTMS to ensure billing of study procedures to the appropriate funding source.
Coordinates participant tests and procedures.
Collects data as required by the protocol. Assures timely completion of Source Documents.
Maintains study timelines.
Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Gastro Health Research Policy on Investigational Drug/Device Accountability.
Completes study documentation and maintains study files in accordance with sponsor requirements and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
Retains all study records in accordance with sponsor requirements and Gastro Health Research policies and procedures.
Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.
Project Closeout
Assists the Principal Investigator and Regulatory Specialist in submission of accurate and timely closeout documents to applicable federal agencies, and the sponsoring agency in accordance with federal regulations and sponsoring agency policies and procedures.
Arranges secure storage of study documents that will be maintained according to Gastro Health Research policy or for the contracted length of time, whichever is longer.
Minimum Requirements
Clinical research experience preferred
Previous phlebotomy skills
High School Diploma
Interested in learning more? Click here to learn more about the location.
Gastro Health is the one of the largest gastroenterology multi-specialty groups in the United States, with over 130+ locations throughout the country. Our team is composed of the finest gastroenterologists, pediatric gastroenterologists, colorectal surgeons, and allied health professionals. We are always looking for individuals that share our mission to provide outstanding medical care and an exceptional healthcare experience. We offer a comprehensive benefits package to our eligible employees.
Gastro Health is proud to be an Equal Opportunity Employer. We do not discriminate based on race, color, gender, disability, protected veteran, military status, religion, age, creed, national origin, gender identity, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.
We thank you for your interest in joining our growing Gastro Health team!
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 Homewood, AL
Clinical Research Coordinator, Full-Time, Homewood, AL
At AllerVie Health, our team members are unified around our mission to help patients achieve and maintain optimal health and quality of life - free from the symptoms and suffering of allergies, asthma, and related immunological conditions. From our physician and clinical roles to our administrative and operational support roles and everything in between, we change lives for the better - giving people their lives, health, and vitality back in real, tangible ways. We live every day on a mission and wake up excited to tackle new challenges and provide people with health solutions.
Summary of Position:
The Clinical Research Coordinator is responsible for coordinating and executing clinical research protocols at the site level. This role ensures protocol adherence, patient safety, accurate data collection, and compliance with all regulatory requirements. The CRC plays a key role in supporting investigators and managing day-to-day clinical trial activities.
Key Responsibilities:
Participant management
Screen, recruit, and obtain informed consent in collaboration with the PI; meet chart-review, screening, and enrollment targets within defined timelines.
Coordinate enrollment, baseline assessments, treatment, and follow-up per protocol; monitor patient compliance and proactively address conflicts.
Schedule and conduct study visits (vital signs, specimen collection, questionnaires/ePRO) and document all procedures per GCP.
Data, documentation & systems
Ensure timely, accurate eSource and EDC entry following ALCOA-C principles; resolve data queries within protocol-defined timelines.
Maintain complete study records: source documents, CRFs, regulatory binders, and the Investigator Site File (ISF), including protocol/version control.
Update required technology/sponsor systems on time and ensure continuous data availability for sponsor review.
Warehouse/archive data and study documents at study closeout.
Compliance & patient safety
Conduct all activities in accordance with study protocols, GCP, and regulatory requirements.
Monitor patient safety and promptly report adverse events to the appropriate parties.
Site operations & logistics
Ensure adequacy and readiness of study supplies (lab kits, investigational products, medical/clinic supplies, ePRO devices) and manage accountability per study requirements.
Prepare for and support interim monitoring visits, audits, and inspections; complete findings and follow-ups in a timely, thorough manner.
Sponsor/CRO & stakeholder communication
Serve as a primary contact with sponsors, CROs, monitors, and internal stakeholders regarding site status, visits, queries, and audits.
Attend investigator and study start-up meetings; communicate risks/issues to management well in advance and track to resolution.
Teamwork, training & support
Collaborate effectively with investigators and cross-functional teams; assist with training research assistants and support staff.
Proactively assist the clinical team with administrative tasks and other job-related duties as assigned.
Qualifications:
Bachelor's degree in health sciences, nursing, or a related field required.
At least 1-2 years of clinical research experience preferred.
Strong understanding of GCP, ICH guidelines, and FDA regulations.
Phlebotomy experience a plus.
CRC certification (ACRP or SOCRA) preferred or willing to obtain
Physical Requirements:
Standing or sitting for extended periods.
Ability to move/lift up to 20 lbs.
Occasional patient interaction and light clinical tasks
When you join AllerVie Health, you become part of a purpose-driven team dedicated to transforming lives through compassionate allergy care. We recognize and value the experience, perspective, and commitment you bring to our mission. In return, we offer competitive compensation and comprehensive benefits that empower you to thrive. This support enables you to give your best to the patients who count on us every day.
Benefits:
Medical, Dental, and Vision Insurance Plans
Employer HSA contribution
Employer-Paid Life Insurance
Supplemental benefit offerings
401(k) Plan with employer match
Generous PTO and paid holidays
Learn About Us:
LinkedIn: ************************************************************ View=all
Instagram: *****************************************
AllerVie Health is an Equal Employment Opportunity/Affirmative Action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Assistant Research Coordinator
Clinical research coordinator job in Huntsville, AL
We are looking for candidates in Huntsville, AL with a medical background and excellent interpersonal experience to support, facilitate, and organize daily human clinical trial activities. This person will be an integral part of the research team and play a part in the day-to-day running of human trials.
The following are a list of responsibilities:
experience with standard regulatory submissions (including 1572 and IRB)
review and execute trial activities as outlined in the study protocol
direct and participate in protocol training for research staff
obtain informed consent from potential subjects
write SOPs and update source documents as needed
organize subject binders
have a working knowledge of sponsor/FDA audits
GCP certified
previous clinical trial experience
computer skills are essential (incl. Excel, Adobe, Word, etc)
familiar with device skills including study devices, pt devices, iPhones, etc.
act as the liaison between regulatory authorities and the research team
other duties as needed
Personal Characteristics
honest, high integrity a must
highly organized, detail-oriented, meticulous and thorough
life learner
able to handle increased amounts of paperwork
compassionate and caring
able to work independently
self-motivator
**Salary based on experience. Benefits available if needed.
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-ApplyPrimary Health Clinical Research Study Operations Coordinator
Clinical research coordinator job in Centreville, AL
Research Coordinator
Reports to: Chief Medical Officer
We are seeking a detail-oriented, highly organized Research Coordinator with broad medical knowledge to support and manage clinical research activities. The ideal candidate will play a pivotal role in the planning, implementation, and coordination of research studies. This position requires strong analytical skills, a working knowledge of medical terminology, and the ability to interact effectively with investigators, sponsors, and study participants.
Key Responsibilities:
Coordinate and oversee day-to-day operations of multiple research studies in compliance with study protocols and regulatory requirements.
Screen, recruit, and consent study participants; ensure proper documentation and eligibility assessment.
Meet with site managers and providers to explain study eligibility
Collect, process, and manage clinical and research data accurately and in a timely manner.
Maintain and organize essential regulatory documents, case report forms, and study files.
Monitor study progress, perform regular audits, and ensure data integrity and protocol compliance.
Act as a liaison between investigators and research staff.
Coordinate study visits, procedures, and follow-up schedules for participants.
Assist with writing reports, abstracts, and manuscripts for publication or presentation.
Train new staff or students in research procedures and compliance standards.
Qualifications:
Required:
Travel to Cahaba's rural clinics in Perry, Wilcox counties is required
Based in-person in Centreville
Broad Clinical knowledge required
Ability to manage multiple priorities in a fast-paced environment.
Strong organizational, interpersonal, and communication skills.
Demonstrates a high level of initiative and independence in daily tasks
Cahaba Medical Care is an Equal Opportunity Employer.
Auto-ApplyClinical Research Coordinator
Clinical research coordinator 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.?
Clinical Research Coordinator
Clinical research coordinator job in Montgomery, AL
:
Headquartered in Birmingham, No Resistance is a clinical trial site management organization that performs clinical trials in urgent care centers throughout the north and southeast. We focus on sample collection and testing trials for lab device manufacturers with the purpose of collecting data to support the device's 510(k) or emergency use approval by the FDA. Notably, the trials we have participated in have directly led to the FDA EUA approval of three separate COVID-19 PCR testing platforms.
No clinical trial experience is required. No Resistance will train the right candidate(s). Hours are Monday-Friday 8:30 am to 5:00 pm with no weekend requirements.
Job Description:
No Resistance is seeking motivated individuals to join our team! In this role, you'll play a pivotal part in the implementation and execution of clinical research projects, ensuring the successful attainment of quality, safety, regulatory, and financial objectives.
Job Duties:
Maintaining regulatory binders, inventory of study-specific and clinical supplies.
Recruiting, and enrolling study subjects.
Obtaining informed consent.
Collecting nasal swab samples.
Testing samples on investigational laboratory PCR analyzers.
Data collection and entry.
Query resolution.
Assuring protocol compliance and efficient workflow including organizing clinical work areas, tracking and ordering study supplies and shipping materials, checking and replacing expired items, etc.
Key Success Factors:
Ability to work independently.
Desire to work in a clinical environment with direct patient contact.
Genuine interest in research.
Timely in all communications.
Superior attention to detail.
While not a requirement, senior pre-medical students who hope to gain experience in clinical research or recent graduates who have a "gap" year before they start medical school are encouraged to apply. This position offers an exceptional opportunity to earn a competitive income while gaining invaluable experience highly regarded by medical school admission committees.
Job Type: Full-time
Pay: $25.00 per hour
Expected hours: 40 per week
Benefits:
401(k)
Dental Insurance
Health Insurance
Paid time off
Vision Insurance
Schedule:
Monday to Friday
Work Location: In person
You must be local to the area!
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
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
Clinical Research Coordinator/DHS II - Alabama 10.3.25
Clinical research coordinator job in Alabama
About N-Power Medicine N-Power Medicine aims to establish a new paradigm in drug development by reinventing the ‘how' and transforming clinical trials through better integration with clinical practice, ensuring broader participation by physicians and patients. We are building an exceptional multi-disciplinary team with diverse expertise spanning healthcare, engineering, technology and regulatory, and with people who share our core value of Empowering Community through generosity, curiosity and humility. We are working with urgency to bring better therapies to patients faster.
Position Summary
You will be a part of the rapidly changing clinical oncology environment with the opportunity to impact the future of clinical research and improve patients' lives while growing professionally at a dynamic, fast-growing, start-up organization. As the Digital Health Specialist II (internal title), you will work at a clinical site in either Tuscaloosa and/or Anniston, Alabama.
The ideal candidate has clinical oncology research experience or research experience in a healthcare setting. You are confident in your understanding of clinical workflow, patient data systems and clinical research in an oncology setting. We are looking for individuals who are motivated and ambitious professionals who desire to positively influence and innovate upon the quality of care for patients diagnosed with cancer.
Roles and Responsibilities
Serve as the Company's trusted face to the clinical practice, providing clinical support while advancing research data collection.
Interface directly with the healthcare providers and patients.
Perform peer review of clinical documentation for data quality and completeness.
Partner with Senior DHS to address any clinic or team issues and concerns.
Obtain informed consent for N-Power Medicine's clinical trials.
Assist and participate in the site clinical trial initiation and clinical trial(s) activities as assigned.
Ensure adherence to study protocols, data completeness and patient consent.
Assist in patient recruitment strategies where appropriate.
Foster collaborative relationships by effectively communicating with clinical site staff, internal stakeholders, and the N-Power Medicine team by attending site specific meetings.
Build and maintain relationships at the clinical site, becoming part of the functional team of practitioners.
Ensure quality and integrity of data capture, compliance and confidentiality with N-Power Medicine's and site's policies, standard operating procedures (SOPs), and Good Clinical Practice (GCP).
Respond to queries regarding missing, aberrant, or potential outlier data and data verification- escalate to the health care provider as necessary for resolution.
Provide proactive input and user experiences for our software.
Additional duties and responsibilities as required.
Generous, curious and humble.
Qualifications
3+ years of experience in oncology clinical research and/or oncology ambulatory care preferred
Bachelor's degree, focused in health science or related field preferred
Certified Clinical Research Coordinator, Associate or Professional (CCRC, CCRA or CCRP) preferred
Knowledge of clinical trials, study-specific operating procedures and patient consent forms
Strong desire to drive a paradigm change in clinical research conduct and improve patients' lives
Compassionate focused patient care
Supports and encourages other team members, contributing to a positive team environment
Self-starter, able to work independently, prioritize actively, seek input, and problem solve in complex and fast-evolving environments
Results oriented focused on delivering the goals set-forth
Attention to detail and strong organizational skills
Excellent oral/written communication and interpersonal skills
Critical thinking and proven problem-solving skills
Work hours are dependent on local Network Partner Clinics (typically M-F, 8-5pm)
Please note that state-specific background checks and screenings may be required for this role. Employment is contingent upon successfully passing all applicable screenings.
Travel Requirements
Daily travel between sites may be required
$99,000 - $149,000 a year
The expected salary range for this position is $99,000 and $149,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. N-Power Medicine (NPM) offers equity at hire as well as a discretionary annual bonus which may be available based on Company performance. This position is eligible for company benefits.
More About UsWe are a mission driven, well -funded, rapidly growing company, eager to attract passionate professionals offering a highly attractive compensation package with a balanced and flexible work environment, competitive industry benefits as well as a 401K plan and other great company “perks.”
We are an Equal Opportunity Employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Covid-19 Policy - The Company is committed to providing and maintaining a safe workplace, and to safeguard the health and well-being of our employees, families, visitors, and the community. While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary. We currently do not have mandatory COVID-19 vaccination requirements for our employees and contractors, as the COVID-19 public health emergency has ended. However, there are certain N-Power Medicine employees and contractors who, based on their role, will be required to continue to follow our 2021 COVID-19 vaccination and other requirements as mandated by N-Power Medicine's partners they serve. We reserve the right to modify or amend our corporate policy at any time.
Applicants must be currently authorized to work in the U.S. on a full-time basis. The Company will not sponsor applicants for work visas.
If you find this opportunity compelling, we encourage you to apply today! We promptly review all applications. Highly qualified candidates will be directly contacted by a team member.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Auto-ApplyClinical Research Coordinator
Clinical research coordinator 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 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.
Clinical Research Associate II
Clinical research coordinator job in Kinsey, AL
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
Clinical Research Coordinator, MH-CIP (Spanish-speaking preferred)
Clinical research coordinator job in New Orleans, LA
The primary responsibility of the Clinical Research Coordinator is to coordinate and conduct the day-to-day operation of clinical studies and clinical trials related to maternal health and diabetes. The Clinical Research Coordinator assists the investigator team to develop study protocols and manuals of procedures. The Clinical Research Coordinator screens, enrolls and follows study participants, conducts data collection and entry, and performs noninvasive cardiovascular tests according to study protocols. The Clinical Research Coordinator is also responsible for keeping all data and source documentation, adverse event reporting, and IRB regulatory files.• 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
The education required for each level is listed below:
Clinical Research Coordinator I (Pay Grade 23)
* Licensed Practical Nurse with current state licensure at the time of hire and 3 years of related work experience
OR
* Bachelor's Degree or Registered Nurse with current state licensure at the time of hire
Clinical Research Coordinator II (Pay Grade 24)
* Licensed Practical Nurse with current state licensure at the time of hire and 4 years of related work experience
OR
* Bachelor's Degree or Registered Nurse with current state licensure at the time of hire and 1 year of related work experience
OR
* Master's Degree in a related field
Clinical Research Coordinator III (Pay Grade 25)
* Licensed Practical Nurse with current state licensure at the time of hire and 5 years of related work experience
OR
* Bachelor's Degree or Registered Nurse with current state licensure at the time of hire and 2 years of related work experience
OR
* Master's Degree in a related field and 1 year of related experience
FOR ALL LEVELS: Spanish language fluency-oral and written
Level I
* Expressed interest in Clinical Research
* Motivated to learn about Clinical Research and associated regulations
Level II
* Knowledge of IRB submission process and requirements
* Knowledge of good clinical practices as set forth by federal regulations
Level III
* 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)
* Supervisory experience
Clinical Research Coordinator II
Clinical research coordinator 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 studies and clinical trials. The Clinical Research Coordinator II assists the investigator team in developing study protocols and manuals of procedures. The Clinical Research Coordinator II screens, enrolls, and follows study participants, conducts data collection and entry, and performs tests according to study protocols. The Clinical Research Coordinator II is also responsible for keeping all data and source documentation, adverse event reporting, and IRB regulatory files.• 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
* 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]).
* 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
* 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