Clinical research associate jobs in Lafayette, LA - 62 jobs
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Senior Clinical Research Coordinator
Lead Clinical Research Associate
Oracle 4.6
Clinical research associate job in Baton Rouge, LA
With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us!
As a global leader we're looking for a Senior **Lead ClinicalResearchAssociate (CRA)** to drive success as part of our Non-interventional Study team.
Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinicalresearch, and driving groundbreaking projects on a global scale!
**What you will do**
**As a Senior Lead ClinicalResearchAssociate at Oracle, you will:**
+ **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors.
+ **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters.
+ **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents.
+ **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans.
+ **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of ClinicalResearchAssociates, develop project-specific training materials, and ensure delivery of high-quality site management.
+ **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports.
+ **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement.
+ **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required.
**Required Experience**
+ **Education** : Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years' hands-on clinicalresearch experience.
+ **Clinicalresearch expertise** : At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies.
+ **Communication skills** : Outstanding spoken and written proficiency in English (C1 level minimum).Additional languages are considered a strong asset.
+ **Technical proficiency** : Comfort with MS Office, EDC, CTMS exprience and willingness to learn and handle various technical systems and tools.
+ **Personal qualities** : Exceptional organizational and problem-solving skills, strong cross-culturalteamwork, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment.
+ **Financial management:** Experience reviewing site contracts, budget and invoices.
+ **Attention to detail** : Ability to work independently with careful, precise, and thorough execution of complex tasks.
**Responsibilities**
**What you will do**
**As a Senior Lead ClinicalResearchAssociate at Oracle, you will:**
+ **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors.
+ **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters.
+ **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents.
+ **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans.
+ **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of ClinicalResearchAssociates, develop project-specific training materials, and ensure delivery of high-quality site management.
+ **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports.
+ **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement.
+ **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required.
Disclaimer:
**Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.**
**Range and benefit information provided in this posting are specific to the stated locations only**
US: Hiring Range in USD from: $70,600 to $141,200 per annum. May be eligible for bonus and equity.
Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business.
Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.
Oracle US offers a comprehensive benefits package which includes the following:
1. Medical, dental, and vision insurance, including expert medical opinion
2. Short term disability and long term disability
3. Life insurance and AD&D
4. Supplemental life insurance (Employee/Spouse/Child)
5. Health care and dependent care Flexible Spending Accounts
6. Pre-tax commuter and parking benefits
7. 401(k) Savings and Investment Plan with company match
8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
9. 11 paid holidays
10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
11. Paid parental leave
12. Adoption assistance
13. Employee Stock Purchase Plan
14. Financial planning and group legal
15. Voluntary benefits including auto, homeowner and pet insurance
The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
Career Level - IC3
**About Us**
As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States.
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
$70.6k-141.2k yearly 4d ago
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Clinical Research Associate II
Allen Spolden
Clinical research associate job in New Orleans, LA
Responsible for providing ClinicalResearch 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 clinicalresearch 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 clinicalresearch 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
$43k-69k yearly est. 60d+ ago
Sr. Clinical Research Associate - FSP
Parexel 4.5
Clinical research associate job in Baton Rouge, LA
**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The ClinicalResearchAssociate (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.
$79k-103k yearly est. 42d ago
Senior Clinical Research Coordinator - Women's Services - Baptist
Ochsner Health 4.5
Clinical research associate job in New Orleans, LA
**We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate,** **and innovate. We believe** **that every award earned, every record broken and every patient helped is because of the dedicated employees who fill our hallways.**
**At Ochsner, whether you work with patients** **every day** **or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today!**
This job evaluates initiates and maintains activities related to the conduct of clinical trials in multiple assigned area(s) of responsibility. Communicates effectively with external funding agencies and sponsors, other departments, departmental staff and patients to assure the understanding of the requirements of conducting and participating in clinical trials. Independently organizes and manages all documentation and regulatory submissions as required by the sponsor of the trial, regulatory agencies, Research division/OHS policy and patient care requirements of Ochsner. Functions as project manager for clinical trials in assigned area(s) of responsibility and serves as an escalation point for junior level departmental staff for problem resolution and support.
**Education**
Required - High School diploma or equivalent
Preferred - Bachelor's degree in Science or related field; Master's degree in Public Health or related field
**Work Experience**
Required - 9 years relevant research experience; or 6 years of research experience in a clinical setting with a Bachelor of Science degree
Preferred- Experience in area of assigned clinical specialty
Experience in clinicalresearch
Experience with data entry and data base management
**Certifications**
Current Basic Life Support (BLS) certification from the American Heart Association
**Knowledge Skills and Abilities (KSAs)**
+ Must have computer skills and dexterity required for data entry and retrieval of required job information.
+ Must be proficient with Windows-style applications and keyboard, and various software packages specific to role.
+ Effective verbal and written communication skills and the ability to present information clearly and professionally to varying levels of individuals throughout the required job processes.
+ Strong interpersonal skills.
+ Critical thinking skills to apply to the process of trial evaluation and submission, particularly the development of study related budgets, contracts and patient consent documents.
+ Ability to effectively work independently.
+ Strong organizational and prioritization skills.
+ Working knowledge and experience in clinicalresearch.
+ Ability and willingness to learn and apply new techniques.
+ Reliable transportation to travel across the system.
+ Ability to work flexible hours, when applicable.
**Job Duties**
+ Coordinates and oversees the regulatory processes as they relate to the evaluation, initiation, maintenance, closure and internal and external audit of clinical trials and other research activity.
+ Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials.
+ Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
+ Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
+ Maintains competency in requirements and regulations associated with the conduct of clinical trials and other related research activity.
+ Supports department, divisions and institutional goals.
+ Provides mentorship, professional development and support to other ClinicalResearch Coordinators.
+ Other related duties as required.
The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.
Ochsner is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
**Physical and Environmental Demands**
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible.
Mechanical lifting devices (carts, dollies, etc.) or team lifts should be utilized.
Must be able to sit for prolonged periods of time.
Must be able to travel throughout and between facilities.
Must be able to work a flexible work schedule.
The incumbent works in a patient care area; works in an area where patients enter; works directly with patients; and/or works with specimens that could contain diseases. There may be an occupational risk for exposure to all communicable diseases.
**Are you ready to make a difference? Apply Today!**
**_Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website._**
**_Please refer to the job description to determine whether the position you are interested in is remote or on-site._** _Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland,Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C._
**_Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at ************ (select option 1) or_** **_*******************_** **_. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications._**
Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.
$39k-55k yearly est. 60d+ ago
CLINICAL TRIALS COORDINATOR 3
Louisiana State University Healthcare Network: New Orleans 4.6
Clinical research associate job in Baton Rouge, LA
The Clinical Trials Coordinator 3 will work collectively within a multidisciplinary clinical/research team to ensure that all aspects of patient management are executed both timely and accurately. Incumbent must be comfortable working independently, managing interactions with and between team members, both internally and externally; ensuring that all NIH grant funded, industry-sponsored or investigator driven studies/trials are managed to the highest quality to ensure safety and effectiveness.
The incumbent will promote improved access for patients to clinical trials, and facilitate research activities throughout LSUHSC-affiliated clinics and partner hospitals as assigned.
The incumbent will also prepare and edit clinical study protocols and scientific documents.
$39k-53k yearly est. 30d ago
Clinical Research Coordinator
Southern Urology Lafayette
Clinical research associate job in Lafayette, LA
Job Description
We are seeking a dedicated and detail-oriented ClinicalResearch 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 clinicalresearch 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 clinicalresearch.
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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$37k-55k yearly est. 5d ago
Study Start Up Coordinator
Delricht Research
Clinical research associate job in New Orleans, LA
Salary:
Why DelRicht?
Would you love to be a part of the cutting edge of healthcare and science innovation? Do you enjoy managing projects and making sure everyone on the team has the information they need to be successful? Are you looking for a position that has opportunities for professional growth? If the answer is yes, then DelRicht Research might be the right opportunity for you!
Who We Are
DelRicht is a clinicalresearch company dedicated to providing an excellent customer experience to all patients that participate in our clinical trials. Our clinical trials provide new treatment options for our patients and ultimately our goal is to get new medications and medical devices FDA approved! We hold our team members to a high standard of excellence and are looking for energetic, positive, quick learners to be a part of our team. Presently our network stretches across 33 sites in 18 states.
Position Main Objective: As a DelRicht Study Start Up Coordinator you will play a key role in planning, executing, and overseeing clinicalresearch projects to ensure successful completion while adhering to regulatory guidelines and ethical standards. This is a project management role which requires top-notch communication. Were looking for a go-getter! You will work closely with multiple departments, investigators, and sponsors to ensure successful execution of clinicalresearch protocols.
NOTE:This is a full-time onsite position in New Orleans, LA. No hybrid or remote-seeking candidates, please. Preference will be given to local applicants.
Job Description:
The Study Start Up Coordinator will maintain all activities related to the conduct of clinical trials including but not limited to:
Lead and manage clinicalresearch projects from initiation to completion, ensuring adherence to timelines and quality standards.
Identify project risks and develop strategies to ensure successful project execution.
Monitor study progress and proactively identify any deviations, resolving issues promptly to prevent delays.
Lead and motivate clinical teams to achieve project objectives and milestones.
Facilitate effective communication between team members, clients, and vendors.
Ensure all clinicalresearch activities are conducted in compliance with relevant regulations, Good Clinical Practice (GCP), and company SOPs.
Perform quality checks to ensure data accuracy and integrity, and resolve any discrepancies promptly.
Oversee data collection, analysis, and reporting activities in coordination with the data management team.
Prepare project progress reports, ensuring clear communication of study status and key performance indicators to stakeholders.
The right candidate will:
Be self motivated! Energetic! Positive!
Focus on providing exceptional patient care and creating memorable experiences
Make sure client satisfaction is a primary focus and that the client is able to achieve and exceed their goals
Believe in high quality and have a high standard of compliance to our study protocols
Be remarkably organized
Be skilled at problem solving
Manage multiple tasks and clinical trials efficiently
Accept ownership of tasks from inception through completion and assume responsibility for personal success
Skills needed to win:
Required:
1-2 years of professional work experience
Required:
B.S or B.A from any accredited university
Required:
Proficient in utilizing technology, including relevant software applications and tools required for the role
Preferred:
Proven skill in constructing and analyzing spreadsheets
Preferred:
Experience working cross-functionally across departments/shared services teams, etc.
Coffee drinkers preferred. Tea drinkers accepted.
DelRicht Researchs Core Values:Production, Humility, Consistency
Production:
We deliver on our promises
We have a bias towards action: we value independent problem solving
We proactively over deliver: we can act without being told what to do and we always have new ideas that will be heard and will improve the company
Humility:
We support each other relentlessly
We always have enthusiasm: we exhibit passion and excitement about our work which leads to everyone having a can do attitude
We embrace change: we are excited to always be growing and moving the organization forward which means change is the norm for us
Coachable: we all love to learn, we are willing to be taught and will adapt quickly
Consistency:
We always are able to execute: we get it right the first time and promote touch it once accuracy
We have persistence: we demonstrate the tenacity and willingness to go the distance to get something done
We are calm under pressure: we can maintain stable performance when under heavy pressure or stress
Team Perks & Benefits at DelRicht Research:
Medical, Dental and Vision Insurance
Short Term Disability, Long Term Disability, and Life Insurance
Generous Paid Time Off that builds throughout your career with the company
Even though we are in healthcare, we do not work nights, weekends or 12 hour shifts (yes, nurses love us!)
401K (includes discretionary match/profit sharing)
Exceptional quarterly bonus plan that clearly outlines your bonus potential per quarter
Job Type: Full-time 40+ hrs
Visit our website linked below to learn about our company and current clinical trials, see patient testimonials, and check out our careers page!
Website:************************
Patient Testimonials:******************************************
We are an equal opportunity employer and consider all qualified applicants equally without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
$35k-51k yearly est. 15d ago
Clinical Research Coordinator
Spine Network LLC 3.6
Clinical research associate job in Shreveport, LA
Description:
Applicants must be legally authorized to work in the United States. We are unable to provide visa sponsorship now or in the future.
The ClinicalResearch Coordinator (CRC) is primarily responsible for clinicalresearch 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 clinicalresearch in the medical device and/or pharmaceutical industry with IDE and/or IND experience preferred
Clinicalresearch 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.?
$40k-58k yearly est. 20d ago
Clinical Research Coordinator
LCMC Health 4.5
Clinical research associate job in New Orleans, LA
Your job is more than a job Why a Great Place to Work At LCMC Health we help you to lean into your calling by leaning in with you, ensuring you have the resources to do your job as only you can. And that begins with receiving the support you need to thrive and grow, which looks different for each person. Living out our commitment to inclusion requires providing benefits that are as diverse and unique as our workforce. It's a responsibility we take seriously. Because we don't just serve the New Orleans community-we're at the beating heart of it. Whether by offering community health services or making medical innovations more accessible, LCMC Health is bringing a culture of wellness to the communities that matter to you. When you know you're making an authentic impact, you give a little extra to every day- as a person, with your team, in your community-and that's one of the reasons why you'll be a perfect fit at LCMC Health, where giving a little something extra is at the heart of everything we do.
GENERAL DUTIES
* Coordinates clinical trials projects by studying trial requirements, defining trial scope, designing trial strategy and methodology, developing schedules and timetables.
* Meets clinical trials operational standards by contributing information to strategic plans and reviews, implementing production, productivity, quality, customer-service, safety, security, health standards and by resolving problems.
* Maintains accurate and complete records of the receipt, dispensing, return of all investigational supplies, including study drug(s) or devices and report any discrepancies to the management.
* Supports a system for organizing and planning workflow related to all research study activities. Prepares and presents a summary of clinical trial activities if needed.
* Completes case report forms at time of enrollment and at follow-up visits with appropriate source documentation.
* Ensures all regulatory documents and correspondence is submitted to the appropriate personnel in a timely manner.
* Maintains confidentiality of Protected Health Information (PHI) and keeps all records secure.
EXPERIENCE QUALIFICATIONS
* Required: 2 years of experience in post graduate Medical Education and Medical Research studies.
EDUCATION QUALIFICATIONS
* Required: Bachelor's Degree in a related field.
KNOWLEDGE, SKILLS, AND ABILITIES
* Proficient communication and interpersonal skills required.
* Time management and organizational skills required.
* Astute observational and assessment skills required.
* Utilization of proper body mechanics required.
* Proper operation of spirometer, ECG machine, stadiometer, and scales required.
* Proper operation of computers and fax machines required.
* Ability to utilize telecommunications to interact with study sponsors and research subjects required.
* Basic phlebotomy and vital signs measurement skills preferred.
WORK SHIFT:
Days (United States of America)
LCMC Health is a community.
Our people make health happen. While our NOLA roots run deep, our branches are the vessels that carry our mission of bringing the best possible care to every person and parish in Louisiana and beyond and put a little more heart and soul into healthcare along the way. Celebrating authenticity, originality, equity, inclusion and a little "come on in" attitude is the foundation of LCMC Health's culture of everyday extraordinary
Your extras
* Deliver healthcare with heart.
* Give people a reason to smile.
* Put a little love in your work.
* Be honest and real, but with compassion.
* Bring some lagniappe into everything you do.
* Forget one-size-fits-all, think one-of-a-kind care.
* See opportunities, not problems - it's all about perspective.
* Cheerlead ideas, differences, and each other.
* Love what makes you, you - because we do
You are welcome here.
LCMC Health is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
The above job summary is intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities. LCMC Health reserves the right to amend and change responsibilities to meet organizational needs as necessary.
Simple things make the difference.
1. To get started, take your time to fully and accurately complete the application for employment. Incomplete applications get bogged down and are often eliminated due to missing information.
2. To ensure quality care and service, we may use information on your application to verify your previous employment and background.
3. To keep our career applications up-to-date, applications are inactive after 6 months and, therefore, require a new application for employment to be completed.
4. To expedite the hiring process, proof of citizenship or immigration status will be required to verify your lawful right to work in the United States.
The University of Saint Francis is excited to announce the search for our next Radiologic Technology Clinical Coordinator - Lafayette. The University of Saint Francis in Lafayette, Indiana invites applications for a full-time, non-tenure track position in our Division of Allied Health. The position requires a specialization in Radiography with experience, success, and interest in offering radiography programing in both clinical and instruction formats. The teaching load is 30 credit hours per academic year. Other responsibilities include Provides for the establishment, monitoring and evaluation of clinical rotation sites including the supervision and guidance of preceptors involved in these duties. continuing professional development and a commitment to collaboration and service within the Division, across the University and in the community. The successful candidate must be able to advance the Catholic and Franciscan Mission of the University. Rank and salary are dependent upon the appointee's qualifications and experience. A candidate who has or is able to obtain a bachelor's degree from an accredited school of radiologic technology within a year of employment and a master's degree in a related field or plan in progress and completion within five years of date of hire is required for this position.
Interested applicants should complete the online application, and include a letter of application, a CV, and the contact information for three references. The letter of application should directly address the responsibilities of the position with special emphasis placed upon the candidate's teaching experience and ability as well as how the applicant will seek to advance the Catholic, Franciscan Mission of the University. Finalists will be required to provide official transcripts. Review of applications will begin immediately and will continue until the position is filled.
The University of Saint Francis offers formation of the whole person by providing an encounter with the heart and mind of Jesus Christ so that God, who is Love, may be loved. Through our Catholic identity, Franciscan charism, and liberal arts tradition, we prepare students for personal and professional lives of virtue, service, and joy.
USF core values are the standards of behavior for every member of the university. They reflect those of the Sisters of Saint Francis of Perpetual Adoration and bring their charism to the university.
* Ceaseless Adoration - We adore God and interact with others in a way that honors His Presence.
* Generous Love - we spend time in community, give of ourselves, and accept help from others.
* Franciscan Joy - we delight in the simple things and give thanks in all circumstances.
The University of Saint Francis promotes and celebrates the Catholic identity and Franciscan charism of the institution with an invitation to students, faculty and staff of all faiths. This God-centered and student-focused approach invites all employees to be a part of the formation of the whole person (students and colleagues) in a learning and working environment where character development and faith formation are as essential as academic achievement. Molding well-rounded, faith-filled, ethical leaders is the essence of the university's approach and all employees are expected to engage in a way that fulfills and furthers the mission.
The university's strategic plan can be found at: *****************************
Job Description
$49k-61k yearly est. 14d ago
Clinical Research Coordinator
Tandem Intermediate 4.8
Clinical research associate job in Marrero, LA
Description:
ClinicalResearch Coordinator (CRC)
The ClinicalResearch Coordinator (CRC) is responsible for overseeing and managing the daily operational activities of assigned clinicalresearch studies. This role works closely with investigators, clinical staff, study participants, sponsors, and CROs to ensure that all research activities are conducted in compliance with study protocols, regulatory requirements, and ethical standards.
The CRC serves as the primary owner of study coordination, documentation, data management, and sponsor communication, supporting compliant trial execution from study start-up through close-out.
Key Responsibilities
Study Management & Coordination
Organize, plan, and coordinate all aspects of assigned clinical trials from initiation through close-out.
Support study start-up activities including feasibility, regulatory submissions, and site activation.
Attend investigator meetings, site initiation visits, and other study-related meetings.
Manage visit schedules and coordinate study-related activities across clinical teams.
Recruitment, Enrollment & Consent
Collaborate with recruitment teams to support participant screening and enrollment.
Conduct informed consent discussions with participants, ensuring understanding of study requirements and documentation of consent.
Ensure protocol and regulatory requirements are met throughout the enrollment process.
Clinical Oversight & Subject Monitoring
Monitor and assess study subjects in accordance with protocol requirements.
Identify, document, and report adverse events in collaboration with the Principal Investigator and clinical staff.
Escalate safety concerns and protocol issues to the PI, sponsor, and IRB as required.
Documentation, Data & Systems
Maintain accurate and complete source documentation, case report forms, regulatory files, and study records.
Enter study data into EDC and other required systems and manage study databases.
Complete, verify, and resolve case report forms and sponsor or monitor queries in a timely manner.
Report protocol deviations to the PI, sponsor, and IRB as required.
Investigational Product & Specimen Management
Manage investigational product accountability records and documentation.
Collect, process, package, and ship study specimens per protocol requirements.
Perform phlebotomy and handle biological specimens in accordance with study protocols and safety guidelines, when trained and authorized.
Quality, Compliance & Team Support
Ensure all study activities comply with SOPs, GCP, and regulatory requirements.
Support quality assurance activities and audit readiness.
Provide assistance and mentorship to fellow coordinators as needed.
Maintain strict confidentiality of participant and study information.
Communication & Outreach
Serve as the primary point of contact for sponsor and CRO communications.
Participate in occasional outreach or community events related to clinical trials.
Ensure timely, accurate communication of study updates and issues.
Additional Responsibilities
This job description outlines the primary responsibilities of the ClinicalResearch Coordinator but is not exhaustive. Additional duties may be assigned as needed to support study requirements, operational needs, and organizational priorities. Responsibilities may evolve based on protocol complexity and business needs.
Requirements:
Knowledge, Skills, and Abilities
• Strong leadership and communication skills
• Exceptional organizational and multitasking abilities
• High attention to detail and commitment to regulatory compliance
• Ability to work independently and collaboratively in a multidisciplinary environment
• Strong time management and operational efficiency skills
• Proficiency with office equipment and study-specific systems
• Ability to maintain strict confidentiality
Required Experience & Qualifications
• Education: Bachelor's degree in a related field
• Experience: Minimum of two (2) years of clinicalresearch or clinical trial management experience
• Preferred Credentials: Medical certification or licensure (e.g., MS, LPN, RN)
• Phlebotomy: Prior experience performing blood draws and handling biological specimens required
$42k-58k yearly est. 2d ago
Clinical Research Coordinator II
Tulane University 4.8
Clinical research associate job in New Orleans, LA
The primary responsibility of the ClinicalResearch Coordinator II is to manage all aspects of conducting clinical trials. The ClinicalResearch 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 ClinicalResearch Coordinator II acts as a liaison between the patient, investigator, Institutional Review Board and sponsor. The ClinicalResearch 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 ClinicalResearch Coordinator III position. The ClinicalResearch Coordinator is responsible for all data and source documentation, adverse event reporting and maintenance of complete regulatory files, under direct supervision.
* Knowledge of good clinicalresearch 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
$38k-44k yearly est. 42d ago
Clinical Coordinator - Green Clinic
Northern Louisiana Medical Center 3.0
Clinical research associate job in Ruston, LA
Job Description
The Clinical Coordinator will assist the Director of Nursing in the planning, development, financial and staff activities of the Clinics. Complies with organization, department and regulatory standards. Plans the management of staff and ensures sound fiscal operations. Position provides direction, support and guidance to the clinical staff in their development both clinically and professionally. Strong leadership and management skills required.
LPN License Required
Job Posted by ApplicantPro
$53k-75k yearly est. 15d ago
Clinical Research Associate 1
Allen Spolden
Clinical research associate job in New Orleans, LA
Responsible for providing ClinicalResearch 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 clinicalresearch 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 clinicalresearch 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
$43k-69k yearly est. 60d+ ago
Senior Clinical Research Associate/Clinical Research Associate II - Oncology - US - FSP
Parexel 4.5
Clinical research associate job in Baton Rouge, LA
**Job Purpose:** The Senior ClinicalResearchAssociate (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 ClinicalResearchAssociates
**Skills:**
+ Monitoring Experience: Minimum 3 years relevant experience in clinicalresearch site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
+ Preferred therapeutic experience in Oncology
+ Global clinical trial experience preferred
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Travel (60-80%) within area is required
+ Valid driver's license and passport required
**Knowledge and Experience:**
+ Demonstrated knowledge of clinicalresearch and development processes and ability to gain command of process details
+ Demonstrated knowledge of global and local regulatory requirements
+ Demonstrated understanding of key operational elements of clinicalresearch (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
+ Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)
+ Demonstrated ability to support sponsor regulatory interactions/inspections
+ Demonstrated knowledge of the processes around protocol design and feasibility assessment
+ Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
+ Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial
+ Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation
+ Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required
\#LI-CF1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$79k-103k yearly est. 45d ago
Senior Clinical Research Coordinator - Women's Services - Baptist
Ochsner Health System 4.5
Clinical research associate job in New Orleans, LA
We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate, and innovate. We believe that every award earned, every record broken and every patient helped is because of the dedicated employees who fill our hallways.
At Ochsner, whether you work with patients every day or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today!
This job evaluates initiates and maintains activities related to the conduct of clinical trials in multiple assigned area(s) of responsibility. Communicates effectively with external funding agencies and sponsors, other departments, departmental staff and patients to assure the understanding of the requirements of conducting and participating in clinical trials. Independently organizes and manages all documentation and regulatory submissions as required by the sponsor of the trial, regulatory agencies, Research division/OHS policy and patient care requirements of Ochsner. Functions as project manager for clinical trials in assigned area(s) of responsibility and serves as an escalation point for junior level departmental staff for problem resolution and support.
Education
Required - High School diploma or equivalent
Preferred - Bachelor's degree in Science or related field; Master's degree in Public Health or related field
Work Experience
Required - 9 years relevant research experience; or 6 years of research experience in a clinical setting with a Bachelor of Science degree
Preferred- Experience in area of assigned clinical specialty
Experience in clinicalresearch
Experience with data entry and data base management
Certifications
Current Basic Life Support (BLS) certification from the American Heart Association
Knowledge Skills and Abilities (KSAs)
Must have computer skills and dexterity required for data entry and retrieval of required job information.
Must be proficient with Windows-style applications and keyboard, and various software packages specific to role.
Effective verbal and written communication skills and the ability to present information clearly and professionally to varying levels of individuals throughout the required job processes.
Strong interpersonal skills.
Critical thinking skills to apply to the process of trial evaluation and submission, particularly the development of study related budgets, contracts and patient consent documents.
Ability to effectively work independently.
Strong organizational and prioritization skills.
Working knowledge and experience in clinicalresearch.
Ability and willingness to learn and apply new techniques.
Reliable transportation to travel across the system.
Ability to work flexible hours, when applicable.
Job Duties
Coordinates and oversees the regulatory processes as they relate to the evaluation, initiation, maintenance, closure and internal and external audit of clinical trials and other research activity.
Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials.
Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
Maintains competency in requirements and regulations associated with the conduct of clinical trials and other related research activity.
Supports department, divisions and institutional goals.
Provides mentorship, professional development and support to other ClinicalResearch Coordinators.
Other related duties as required.
The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.
Ochsner is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Physical and Environmental Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible.
Mechanical lifting devices (carts, dollies, etc.) or team lifts should be utilized.
Must be able to sit for prolonged periods of time.
Must be able to travel throughout and between facilities.
Must be able to work a flexible work schedule.
The incumbent works in a patient care area; works in an area where patients enter; works directly with patients; and/or works with specimens that could contain diseases. There may be an occupational risk for exposure to all communicable diseases.
Are you ready to make a difference? Apply Today!
Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website.
Please refer to the job description to determine whether the position you are interested in is remote or on-site.
Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland, Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C.
Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at ************ (select option 1) or
*******************
. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.
$39k-55k yearly est. Auto-Apply 60d+ ago
Clinical Research Coordinator
Southern Urology Lafayette
Clinical research associate job in Lafayette, LA
We are seeking a dedicated and detail-oriented ClinicalResearch 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 clinicalresearch 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 clinicalresearch.
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
$37k-55k yearly est. Auto-Apply 60d+ ago
Study Start Up Coordinator
Delricht Research
Clinical research associate job in New Orleans, LA
Why DelRicht?
Would you love to be a part of the cutting edge of healthcare and science innovation? Do you enjoy managing projects and making sure everyone on the team has the information they need to be successful? Are you looking for a position that has opportunities for professional growth? If the answer is yes, then DelRicht Research might be the right opportunity for you!
Who We Are
DelRicht is a clinicalresearch company dedicated to providing an excellent customer experience to all patients that participate in our clinical trials. Our clinical trials provide new treatment options for our patients and ultimately our goal is to get new medications and medical devices FDA approved! We hold our team members to a high standard of excellence and are looking for energetic, positive, quick learners to be a part of our team. Presently our network stretches across 33 sites in 18 states.
Position Main Objective: As a DelRicht Study Start Up Coordinator you will play a key role in planning, executing, and overseeing clinicalresearch projects to ensure successful completion while adhering to regulatory guidelines and ethical standards. This is a project management role which requires top-notch communication. We're looking for a go-getter! You will work closely with multiple departments, investigators, and sponsors to ensure successful execution of clinicalresearch protocols.
NOTE: This is a full-time onsite position in New Orleans, LA. No hybrid or remote-seeking candidates, please. Preference will be given to local applicants.
Job Description:
The Study Start Up Coordinator will maintain all activities related to the conduct of clinical trials including but not limited to:
Lead and manage clinicalresearch projects from initiation to completion, ensuring adherence to timelines and quality standards.
Identify project risks and develop strategies to ensure successful project execution.
Monitor study progress and proactively identify any deviations, resolving issues promptly to prevent delays.
Lead and motivate clinical teams to achieve project objectives and milestones.
Facilitate effective communication between team members, clients, and vendors.
Ensure all clinicalresearch activities are conducted in compliance with relevant regulations, Good Clinical Practice (GCP), and company SOPs.
Perform quality checks to ensure data accuracy and integrity, and resolve any discrepancies promptly.
Oversee data collection, analysis, and reporting activities in coordination with the data management team.
Prepare project progress reports, ensuring clear communication of study status and key performance indicators to stakeholders.
The right candidate will:
Be self motivated! Energetic! Positive!
Focus on providing exceptional patient care and creating memorable experiences
Make sure client satisfaction is a primary focus and that the client is able to achieve and exceed their goals
Believe in high quality and have a high standard of compliance to our study protocols
Be remarkably organized
Be skilled at problem solving
Manage multiple tasks and clinical trials efficiently
Accept ownership of tasks from inception through completion and assume responsibility for personal success
Skills needed to win:
Required:
1-2 years of professional work experience
Required:
B.S or B.A from any accredited university
Required:
Proficient in utilizing technology, including relevant software applications and tools required for the role
Preferred:
Proven skill in constructing and analyzing spreadsheets
Preferred:
Experience working cross-functionally across departments/shared services teams, etc.
Coffee drinkers preferred. Tea drinkers accepted.
DelRicht Research's Core Values: Production, Humility, Consistency
Production:
We deliver on our promises
We have a bias towards action: we value independent problem solving
We proactively over deliver: we can act without being told what to do and we always have new ideas that will be heard and will improve the company
Humility:
We support each other relentlessly
We always have enthusiasm: we exhibit passion and excitement about our work which leads to everyone having a ‘can do' attitude
We embrace change: we are excited to always be growing and moving the organization forward which means change is the norm for us
Coachable: we all love to learn, we are willing to be taught and will adapt quickly
Consistency:
We always are able to execute: we get it right the first time and promote ‘touch it once' accuracy
We have persistence: we demonstrate the tenacity and willingness to go the distance to get something done
We are calm under pressure: we can maintain stable performance when under heavy pressure or stress
Team Perks & Benefits at DelRicht Research:
Medical, Dental and Vision Insurance
Short Term Disability, Long Term Disability, and Life Insurance
Generous Paid Time Off that builds throughout your career with the company
Even though we are in healthcare, we do not work nights, weekends or 12 hour shifts (yes, nurses love us!)
401K (includes discretionary match/profit sharing)
Exceptional quarterly bonus plan that clearly outlines your bonus potential per quarter
Job Type: Full-time 40+ hrs
Visit our website linked below to learn about our company and current clinical trials, see patient testimonials, and check out our careers page!
Website: ************************
Patient Testimonials: ******************************************
We are an equal opportunity employer and consider all qualified applicants equally without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
$35k-51k yearly est. 14d ago
Clinical Research Coordinator II
Tulane University 4.8
Clinical research associate job in New Orleans, LA
The primary responsibility of the ClinicalResearch Coordinator II is to coordinate and conduct the day-to-day operation of clinical trials and other epidemiological studies. The ClinicalResearch Coordinator II is required to have knowledge of protocol requirements and good clinical practices as set forth by federal regulations. The ClinicalResearch Coordinator II is able to recruit, follow, and retain study participants, and perform study visits, data collection and entry, and quality control activities according to study protocol independently. The ClinicalResearch Coordinator II is also able to perform procedures required by the study protocol(s), such as blood pressure measurements, EKD, and laboratory processing. The ClinicalResearch Coordinator II is responsible for all data and source documentation, adverse event reporting and maintenance of complete regulatory files, under direct supervision.• Knowledge of good clinicalresearch practice is required
* Must be able to interact well with patients and the general public
* Excellent organization, analytical, interpersonal, and communication skills
* Ability to maintain confidentiality in all work performed
* Proficient in various software programs (including database management [e.g. Access], presentation packages [e.g. PowerPoint], spreadsheets [e.g. Excel], and advanced word processing [e.g. Word]).
* Ability to acquire and maintain all required CITI training certificates
* Ability to acquire and maintain credentialing at all required institutions: Tulane Medical Center, Veterans Administration Hospital/New Orleans, LA and University Medical Center.
REQUIRED BACKGROUND CHECK, PHYSICAL, AND DRUG SCREENING FOR INCUMBENTS WHO HAVE CONTACT OR EXPOSURE TO ANIMALS OR ANIMAL TISSUES:
Selected candidates must complete and pass a background check and an occupational health screening as a condition of employment. For identified jobs, a drug screening will also be required. The background investigation, required occupational health screening, and any required drug screening will be conducted after a conditional employment offer has been extended.• Bachelor's Degree or RN with current state licensure at the time of hire and one (1) year of related work experience;
OR
* LPN with current state licensure at the time of hire and four (4) years of related work experience;
OR
* A Master's Degree in a related field• Knowledge of IRB submission process and requirements.
* Knowledge of good clinical practices as set forth by federal regulations.
$38k-44k yearly est. 60d+ ago
Clinical Coordinator - Green Clinic
Northern Louisiana Medical Center 3.0
Clinical research associate job in Ruston, LA
The Clinical Coordinator will assist the Director of Nursing in the planning, development, financial and staff activities of the Clinics. Complies with organization, department and regulatory standards. Plans the management of staff and ensures sound fiscal operations. Position provides direction, support and guidance to the clinical staff in their development both clinically and professionally. Strong leadership and management skills required.
LPN License Required
How much does a clinical research associate earn in Lafayette, LA?
The average clinical research associate in Lafayette, LA earns between $35,000 and $85,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.
Average clinical research associate salary in Lafayette, LA