Pre-Clinical Scientist
Clinical research coordinator job in Alabama
Orano Med Theranostics Orano Med is seeking a detail-oriented Pre-Clinical Scientist We are seeking a highly motivated Pre-Clinical Scientist with expertise in radiopharmaceutical development to join our Research and Development team. The successful candidate will design, execute, and analyze preclinical studies to support the development of novel radiopharmaceutical compounds. This role offers an opportunity to contribute to groundbreaking therapies and collaborate with cross-functional teams to advance our pipeline toward clinical trials
Key Responsibilities
Design and conduct in vivo and in vitro preclinical studies to evaluate the efficacy, safety, and pharmacokinetics of radiopharmaceutical compounds.
Develop and optimize experimental protocols for radiopharmaceutical research, ensuring compliance with regulatory standards (e.g., GLP).
Analyze and interpret complex datasets, preparing detailed reports and presentations for internal stakeholders and regulatory submissions.
Collaborate with chemistry, and clinical teams to support IND-enabling studies and translate preclinical findings to clinical applications.
Maintain accurate records of experiments and ensure data integrity in accordance with company policies.
Stay current with advancements in radiopharmaceutical science and contribute to the development of innovative research strategies.
Orano strives to provide a total compensation package that brings value to our employees. We also offer highly competitive health and wellness programs, 401(k) contributions, and industry leading paid time off.
Study Coordinator
Clinical research coordinator job in Birmingham, AL
Southern Research + You Discover a career where your work truly matters. Southern Research has been translating science into real-world solutions since 1941. Join our innovative team and enjoy benefits like medical, dental, vision, 401(k) match, life insurance, PTO, an employee assistance program, and more.
General Summary
This position is responsible for performing diverse duties to support both government and commercial studies within the organization. This position is responsible for providing study support by assisting in the planning, scheduling, execution, and closure of study tasks; and compiling, managing, and reviewing study data and documentation. The Study Coordinator will work closely with the Principal Investigator, Co-Principal Investigator, Study Director/Scientist, Project Managers, fellow Study Coordinators, assigned project team members, and associated management for the program. Study Coordinators are expected to share knowledge gained through experience with their peers.
Essential Duties & Responsibilities
Interacts with assigned Subject Matter Expert, Study Director, and Project Manager to effectively execute, conduct, and report for all assigned studies.
* Assists in the initiation or amendment of studies and drafting of Animal Care Use Protocols (ACUP), Biological Project Registration (BPR), study protocols/work requests, tracks study samples throughout study lifecycle.
* Responsible for Provantis study setups; distributing to appropriate teams following Study Director/Responsible Scientist review and approval.
* Primary POC for all Provantis protocol setup inquiries from internal users (i.e., Laboratory Animal Resources (LAR), pathology, etc) and works with Study Directors/LAR to ensure proper Provantis setup prior to study start. Available for critical study phases to address any Provantis issues in real time.
* Tracks progress of studies to ensure timely execution of activities and communicates any changes to study timelines to internal and external teams.
* Works with Study Director/Responsible Scientist in preparation and review of data; ensures quality control is performed and corrections are made prior to submission to report writing team.
* Assures adherence to study schedules by interacting effectively with and providing information to various staff and client groups; prompts individuals and groups of needed results and approaching deadlines; and coordinates needs of one group or person with those of another group or person.
* Formats study report from finalized protocol and protocol amendments and works alongside Study Director or Responsible Scientist in preparation of data, tables, and graphs, as necessary.
* Demonstrates strong organization and communication skills while assisting with multiple projects in various stages of completion.
* Works with the Study Director/Responsible Scientist to compile, summarize, maintain, and archive study data, including review of study data for missing, inaccurate, or improbable results.
* Assists with communicating schedule and procurement requests.
* Maintains study records and archive study data and reports upon study conclusion.
* Observes appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOP), applicable regulatory requirements, and study protocols.
* Performs other coordination duties as required by study, including entering study rooms as necessary.
Requirements/Minumum Qualifications
* Education & Experience
* Bachelor degree with 5 years of program/study coordination experience.
* Ability to learn and utilize specialty software applications (e.g., laboratory information management systems, Provantis, MS Project).
* Good grasp of the fundamental concepts, practices, and procedures of microbiology/ virology/ immunology/ biology.
* Effective verbal and written communication skills including correct grammar, spelling, and punctuation.
* Detail oriented; possess good planning and organizational skills; inquisitive; takes direction well.
* Proficiency with Microsoft Office applications (Windows, Word, Excel, Access, etc.).
* Strong organization skills and capable of multi-tasking.
* Ability to read, understand, retain, and apply knowledge of Good Laboratory Practices (GLP) and other study requirements.
Core Values
Cultivating human connection - putting people first. We know that every individual makes a difference and that no one can do it alone. We believe the world's most powerful resource is human potential. We are an inclusive and courageous team where innovation and diversity of though go hand in hand. We understand that relationships move at the speed of trust.
Operating with precise execution - measuring what matters and owning results as a team. We leverage data to drive decisions that advance science. We recognize the importance of a stable foundation coupled with an agile mindset. We hold ourselves accountable and take pride in our work. We give and receive candid feedback as a gift that keeps us growing.
Harnessing relentless curiosity - our unstoppable, innovative force. We are driven to ask sharp questions and push the boundaries of knowledge. We use creativity and critical thinking as catalysts for finding solutions that change lives. We learn by doing, consistently striving to improve our relationships, training, methodologies, questions and results.
Stewarding a healthy community - implementing sustainable operations for a safe, engaging environment. We don't compromise on safety and health for our employees, customers or community. We believe a healthy community begins with inclusive economic opportunities. We respect the dignity of the patients we ultimately serve. We are motivated to serve communities that are underserved and markets that are overlooked.
Job Specific Behaviors
Relationship Orientation - Develops positive relationships by making others feel their concerns and contributions are important.
Continuous Learning - Proactively seeks performance feedback and identifies approaches to improve personal and others performance and learning.
Tolerance for Stress, Ambiguity & Change - Demonstrates flexibility in applying different approaches to changing work demands.
Effective Communication - Creates a team environment in which information flows freely and decision making is based on a win-win philosophy
Compliance - Applies an understanding of key legal precedents, policies and practices to protect the interests of the organization.
Cross-team Collaboration - Ensures integration and cooperation across organizational boundaries
Attention to Detail - Utilizes established monitoring system, records data accurately and in a timely manner, and ensures accuracy of data.
Planning and Organization - Systematically identifies issues to be addressed and helps plan a course of action for self and others to ensure the accomplishment of specific objective
Operational / Technical Excellence - Ensures that work product (whether service or process) enables the organization to deliver on customer's expectations.
Physical Demands
* Ability to perform work utilizing a computer for extended periods of time.
* Ability to sit for extended periods of time without being able to leave the work area.
* Ability to stand for extended periods of time without being able to leave the work area.
Work Authorization
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Trial Master File (TMF) Specialist Oncology
Clinical research coordinator job in Montgomery, AL
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF.
**Key Responsibilities**
+ Responsible for overall quality, maintenance, and completeness of Trial Master Files.
+ Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues.
+ Develop project specific TMF plan and structure and update the plan as needed.
+ Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained.
+ Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements.
+ Act as a liaison between the Site IRBs and study team to resolve queries and concerns.
+ Provide study team reports or updates regarding status of TMF on a regular basis.
+ Participate in audits and provide documents as requested.
+ Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings.
+ Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings.
+ Champion best practices for building and maintaining TMF health.
**Professional Experience / Qualifications**
+ BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings
+ Knowledge of and direct experience with Trial Master Files.
+ Prior eTMF (e.g. Veeva) administration required.
+ Strong Microsoft Office skills required.
+ Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2).
+ Fundamental knowledge of the conduct of clinical trials is preferred.
+ Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment.
The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at **********************************************
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
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-ApplySenior Machine Learning Researcher
Clinical research coordinator job in Birmingham, AL
Transform Maritime Intelligence with Cutting-Edge AI/ML
Are you an experienced machine learning researcher ready to push the limits of AI in one of the toughest domains-maritime autonomy? At Tocaro Blue, your expertise in designing, training, and deploying custom ML models will directly advance our foundational perception stack, ProteusCore.
As a Senior ML Researcher, you will be the lead architect of Radar (and secondary EO/IR) models for object detection, semantic segmentation, and tracking. You'll design algorithms capable of distinguishing vessels, land, shoreline constructions, wakes, and markers in dynamic maritime environments where off-the-shelf models fall short.
Your work will fuel products used by:
· Defense customers developing USVs/ASVs for the U.S. Navy.
· Commercial OEMs bringing advanced marine ADAS and autopilot features to market.
This role is an opportunity to define the ML foundations of maritime autonomy-where perception evolves from situational awareness, to navigation assistance, to full autonomy.
What You'll Pioneer
Core ML and Autonomy Innovation
· Invent and refine custom deep learning architectures for Radar and EO/IR imagery, with an emphasis on semantic segmentation and temporal tracking, not just detection.
· Develop multi-stage ML pipelines (context + characteristic models, segmentation + classification) tailored to low-SNR Radar returns.
· Train models on proprietary large-scale datasets (millions of Radar samples and camera sequences) with design-of-experiment methods for data collection and annotation.
· Optimize and deploy models to resource-constrained edge hardware (CPU-only and ARM64 platforms), including C++ inference layers.
· Advance fusion-aware ML models that integrate Radar with EO/IR, AIS, and cartography for robust classification in GPS-denied or cluttered environments.
· Collaborate with fusion and autonomy engineers to ensure ML outputs integrate seamlessly into multi-target tracking and SLAM pipelines.
· Contribute to ML-Ops workflows: data management, large-scale training, continuous integration of new field data, and automated evaluation pipelines.
What Sets You Apart
Essential Qualifications
· Advanced degree (MS/PhD) in Electrical Engineering, Computer Science, Robotics, or related field.
· 7+ years applying machine learning and signal processing to real-world dynamic systems (graduate research counts if directly applicable).
· Demonstrated mastery of semantic segmentation and object classification models, ideally applied to non-vision sensor modalities.
· Expert-level Python skills with ML frameworks (TensorFlow/Keras, PyTorch, or equivalent).
Preferred Expertise
· Track record of developing ML models beyond standard YOLO-style detectors, particularly for segmentation of noisy or sparse data (Radar, sonar, or medical imaging).
· Strong background in computer vision and temporal modeling (CNNs, transformers, RNNs for sequential sensor data).
· Experience deploying ML to embedded/edge platforms with optimized C++ inference.
· Knowledge of marine, automotive, or aerial robotics systems.
· Contributions to large-scale ML data pipelines: annotation strategies, dataset balancing, simulation-to-real transfer.
· Passion for pushing the boundaries of AI in GPS-denied, cluttered, and low-visibility environments.
Why Tocaro Blue?
Competitive Compensation & Growth
· $132,000-$160,000 base salary with potential equity in a rapidly growing company.
· Comprehensive benefits: 401(k) with 4% company matching, full health/dental/vision, life & disability insurance, generous PTO.
· Continuous learning via conferences, training, and professional growth.
Innovation-First Culture
· Direct impact on defining the AI backbone of maritime autonomy.
· Work on problems unsolved in automotive AI: Radar segmentation, maritime multi-object tracking, sensor fusion in GPS-denied waters.
· Collaborative environment with elite engineers and researchers.
Flexible Work Environment
· Hybrid and remote options for Southeastern US-based candidates. Offices in Pensacola (FL), Birmingham (AL), and Atlanta (GA).
· Hands-on field validation through monthly data collection trips at our Pensacola test facility.
· A culture that balances innovation with personal growth.
Equal Opportunity & Eligibility
Tocaro Blue, LLC is an equal opportunity employer and we 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.
Individual offers are based are made based on skill and experience, geographic location, as well as role, responsibility, and leadership within the company, and other due diligence. Our hiring team will try to determine whether each candidate fits the job description and may choose, at their discretion, to redirect a candidate to another job offering that is more appropriate.
NOTICE: All candidates for this role must be eligible to access sensitive information and items that requires “US Person status”, which is typically limited to U.S. citizens and legal permanent residents (a.k.a. green card holders), with few exceptions. Tocaro Blue LLC is not able to sponsor work visas for this role.
Clinical 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!
Research Compliance Administrator (Pooled Posting)
Clinical research coordinator job in Auburn, AL
Details Information Requisition Number S4591P Home Org Name Office of Research Compliance Division Name VP for Research and Economic Dev Position Title Research Compliance Administrator (Pooled Posting) Job Class Code HC80 Appointment Status Full-time Part-time FTE Limited Term No Limited Term Length Job Summary
This is a pooled posting. This posting will remain open for an extended period of time and selected applicants will be contacted as future staffing needs arise.
Auburn University's Office of the Sr. Vice President of Research and Economic Development is accepting applications for the position of Research Compliance Administrator. This position contributes to the daily activities of the Research Compliance Program(s) within the Office of Research Compliance (ORC), which includes the Animal Care and Use Program, the Human Research Protection Program, and the Biological Safety Program. This role ensures adherence to federal and state regulations, sponsor-specific requirements, and institutional policies, and its efforts are essential in maintaining the integrity and ethical standards of our research initiatives.
Essential Functions
* Organizes, coordinates, and executes daily activities of the research compliance programs to ensure adherence to regulatory, contractual, and policy requirements.
* Reviews and assists with research protocols, guiding investigators, faculty, and staff through the protocol submission process to ensure compliance.
* Provides subject-matter advice and oversight on non-compliance assessments, inquiries, investigations, audits, and inspections, including preparing necessary reports and follow-ups.
* Develops, reviews, and revises compliance policies, procedures, and guidelines, enhancing institutional and departmental strategies. Establishes goals and objectives to identify successful program indicators.
* Supports accreditation efforts by preparing and submitting annual/interim reports, coordinating re-accreditation materials, and ensuring compliance with accreditation standards.
* Develops and implements educational programs to promote compliance and responsible conduct of research, including conducting training sessions, seminars, and workshops.
* Remains current on regulatory requirements and organizational demands by attending workshops and seminars and disseminates relevant information as needed.
* Performs additional duties as assigned to support the overall mission of the research compliance programs.
Why Work at Auburn?
* Life-Changing Impact: Our work changes lives through research, instruction, and outreach, making a lasting impact on our students, our communities, and the world.
* Culture of Excellence: We are committed to leveraging our strengths, resources, collaboration, and innovation as a top employer in higher education.
* We're Here for You: Auburn offers generous benefits, educational opportunities, and a culture of support and work/life balance.
* Sweet Home Alabama: The Auburn/Opelika area offers southern charm, vibrant downtown scenes, top-ranked schools, and easy access to Atlanta, Birmingham, and the Gulf of Mexico beaches.
* A Place for Everyone: Auburn is committed to fostering an environment where all faculty, staff, and students are welcomed, valued, respected, and engaged.
Ready to lead and shape the future of higher education? Apply today! War Eagle!
Minimum Qualifications
Minimum Qualifications
* Bachelor's degree- No specific discipline
* 4 years of Contracts and grants, compliance, research, research administration, or other related experience.
Minimum Skills, License, and Certifications
Minimum Skills and Abilities
Strong organizational, administrative, communication, and interpersonal skills. |
Proficient computer skills with Internet and MS Office (Outlook, Word, Excel etc.).
Minimum Technology Skills Minimum License and Certifications
Desired Qualifications
Desired Qualifications
* Higher Education experience
* Master's degree
* Knowledge of federal regulations, state laws, and institutional policies and procedures related to animal care and use, human subject research protection, or biological hazards required based on program assignment.
Posting Detail Information
Salary Range $49,220-$83,680 Job Category Research Working Hours if Non-Traditional City position is located in: Auburn State position is located: AL List any hazardous conditions or physical demands required by this position Posting Date 07/16/2025 Closing Date Equal Opportunity Compliance Statement
It is our policy to provide equal employment and education opportunities for all individuals without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, gender expression, pregnancy, age, disability, protected veteran status, genetic information, or any other classification protected by applicable law. Please visit their website to learn more.
Special Instructions to Applicants Quick Link for Internal Postings *******************************************
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Required Documents
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Optional Documents
Supplemental Questions
Required fields are indicated with an asterisk (*).
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Research 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.
Sr. Clinical Research Associate - FSP
Clinical research coordinator job in Montgomery, AL
**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
**Key Accountabilities** :
**Site Management Responsibilities**
+ Contributes to the selection of potential investigators.
+ In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
+ Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
+ Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
+ Actively participates in Local Study Team (LST) meetings.
+ Contributes to National Investigators meetings, as applicable.
+ Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
+ Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
+ Updates CTMS and other systems with data from study sites as per required timelines.
+ Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
+ Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits.
+ Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
+ Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
+ Ensures data query resolution in a timely manner.
+ Works with data management to ensure robust quality of the collected study data.
+ Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
+ Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
+ Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
+ Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
+ Assists site in maintaining inspection ready ISF.
+ Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
+ Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
+ Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
+ Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
+ Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager.
**Compliance with Sponsor Standards**
+ Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).
+ Ensures compliance with local, national, and regional legislation, as applicable.
+ Completes timesheets accurately as required.
**Compliance with Parexel Standards**
+ Complies with required training curriculum.
+ Completes timesheets accurately as required.
+ Submits expense reports as required.
+ Updates CV as required.
+ Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.
**Skills (Essential):**
+ Excellent attention to detail.
+ Good written and verbal communication skills.
+ Good collaboration and interpersonal skills.
+ Good negotiation skills.
+ Proficient in written and spoken English language required.
+ Fluency in local language(s) required.
**Skills (Desirable):**
+ Ability to work in an environment of remote collaborators.
+ Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
+ Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
+ Good analytical and problem-solving skills.
+ Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
+ Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
+ Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
**Knowledge and Experience (Essential)** **:**
+ Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
+ Good knowledge of relevant local regulations.
+ Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
+ Basic understanding of the drug development process.
+ Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
**Knowledge and Experience (Desired):**
+ Familiar with risk-based monitoring approach including remote monitoring.
+ Good cultural awareness.
**Education:**
+ Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
**Other:**
+ Ability to travel nationally/internationally as Required
+ Valid driving license per country requirements, as applicable.
LI-LG4
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Clinical Research Coordinator (LOCATED In Atlanta)
Clinical research coordinator job in Birmingham, AL
Clinical Research Coordinator (LOCATED in Atlanta, GA) MUST be able to relocate on your own to the Atlanta, GA area (no relocation offered) Manage and coordinate oncology clinical research trials, including patient recruitment, protocol development, and data management.
Oversee oncology trials and research projects
Develop research protocols and grant proposals
Perform patient evaluations and administer medications
Train and supervise staff
Ensure compliance with regulations through audits
Manage financial accounts and authorize purchases
Develop strategies for participant recruitment and retention
Interface with study sponsors and resolve queries
Monitor IRB submissions and respond to requests
Qualifications
MUST be able to relocate on your own to the Atlanta, GA area (no relocation offered)
MUST have Clinical Research Coordinator (CRC) experience
3+ years of solid CRC experience in oncology or interventional drug trials in other therapeutic areas
Two years of college in a scientific, health related, or business administration program AND 3 years of clinical research experience
OR
High School Diploma or GED AND3+ years of clinical research experience
Pay and Benefits
The pay range for this position is $28.00 - $30.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
* Medical, dental & vision
* Critical Illness, Accident, and Hospital
* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
* Life Insurance (Voluntary Life & AD&D for the employee and dependents)
* Short and long-term disability
* Health Spending Account (HSA)
* Transportation benefits
* Employee Assistance Program
* Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Birmingham,AL.
Application Deadline
This position is anticipated to close on May 2, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
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.
Clinical Research Coordinator II
Clinical research coordinator job in Homewood, AL
Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator II. The ideal candidate will possess 3+ years of clinical research coordination experience, and have a strong desire to work directly with patients.
Who We Are
ObjectiveHealth is a clinical research company that uses proprietary technology to:
* Increase patient access to research trials within our communities,
* Provide physicians with enhanced care options for current patients, and
* Deliver superior clinical research enrollment metrics to Pharma sponsors
All with the goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that.
Who You Are
* A lover of patient interaction and skilled at providing patient care
* A team player with a bias for action and an attitude that takes personal responsibility
* Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc.
* Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc.
* Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence
* An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others
* A strong advocate for Company values, mission, and initiatives
* Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies
* Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Dermatology, and/or Oncology
What Success Looks Like for This Role
* Taking ownership of assigned studies and patients
* Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction
* Showing up on time, every time
* Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies
* Learning and using the technologies we provide to increase efficiency in your day-to-day activities
* Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication
What We Offer
Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits.
Requirements
This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.
Primary 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 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 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 Coordinator
Clinical research coordinator job in Birmingham, AL
Job Description
The Clinical Coordinator schedules all surgical procedures and assures that all of the appropriate clinical and insurance coding information is collected for the surgery schedule. The Clinical Coordinator receives requests to schedule procedures from physician and schedules the procedure according to established guidelines. The Clinical Coordinator provides accurate information so that all departments may view daily, and maintains open communication with both clinic and surgery staff regarding schedule changes for patients in outpatient clinic setting by performing the following duties.
Responsibilities:
Schedule procedures using Greenway system and manual paper system.
Schedule surgery dates with patients.
Make "quick notes" with procedure codes and ICD-10 codes and task to the pre-cert department.
Follow up to ensure that pre-cert and benefits have been checked and the money has been collected.
Place orders into hospital server for surgery along with any notes/special instructions needed for scheduling in the electronic medical record.
Obtain medical clearance for surgery, if needed.
Interface with appropriate vendor staff/representatives to ensure all necessary equipment will be on site for office and hospital-based procedures.
Ensure proper diagnoses, CPT, ICD-10, and billing codes are documented for each visit and medical procedures performed.
Provide accurate, detailed information to patients regarding test preparations, time of patients' schedule arrival, and any other directional information needed; take appropriate action in responding to questions from patients.
Ensure proper follow-up appointments are scheduled at the time the procedure is scheduled.
Answer the telephone in a professional and courteous manner.
Follow proper procedures for when scheduling all procedures or referrals, whether surgical, MRI or PT/OT.
Obtain all benefits and pre-certs for specialty injections prior to the patient's appointment.
Coordinate DME prescriptions and applications for patients, including obtaining authorization and payment or refer to DME Coordinator.
Coordinate with clinic Physician Assistant to ensure proper patient care.
Check charges daily.
Confirm that clinic notes are faxed.
Keep clinic flowing in an organized manner
Qualifications & Skills:
Minimum of High School diploma or equivalent.
Two years of leadership experience preferred.
One-year related experience and/or training, or equivalent combination of education and experience.
Ability to work independently
Excellent organizational skills
Ability to multi task
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence.
Ability to carry out instructions furnished in written, oral, or diagram form.
Ability to deal with problems involving several concrete variables in standardized situations.
As a member of the Southlake team you can expect:
Generous Paid Time Off based on years of service
Health & Welfare benefits starting the first of the month following your date of hire:
BCBS Medical
Dental
Vision
Company paid Life Insurance
Voluntary Life, Accident, Cancer, and Critical Illness coverage
Employee Assistance Program
401(k) plan after one year of employment
Referral Bonus program
Monday - Friday schedule for most roles
Please note: If you are viewing this position on an external job board (such as Indeed, LinkedIn, ZipRecruiter, etc.), unless specifically stated in the posting, the provided salary estimates may not be accurate as they are not provided by Southlake Orthopaedics. Our staff looks forward to speaking with you about your background, skills, and compensation requirements.
You must be able to pass a pre-employment background check and drug test for employment at Southlake Orthopaedics. Any job offer will be contingent on the results of such background check and drug test.
Job Posted by ApplicantPro
Clinical Response Coordinator - Legacy of Hope
Clinical research coordinator job in Birmingham, AL
Schedule: Shift May Vary Benefits include: 100% tuition assistance, wellness initiatives, generous paid time off, paid parental leave, Public Service Loan Forgiveness Program eligible employer, plus more. In addition to our many benefits and perks, UAB Medicine provides a variety of resources to support employees both personally and professionally.
The Clinical Response Coordinator (CRC) is an integral role within the organ donation process at Legacy of Hope (LoH). The CRC will be responsible for performing on-site visits to donor hospitals within their coverage area. They, in conjunction with the administrator on call, will determine initial suitability of potential organ and tissue donors. This will be done by communicating and interacting with hospital and physician staff in collaborative and professional ways. The CRC will evaluate specific case dynamics and determine which information is clinically significant and should be communicated to the hospital teams and Legacy of Hope staff who are off-site. They will also assess available clinical data found in medical record or bedside assessment to determine initial medical suitability for donation. The CRC will encourage implementation of catastrophic brain injury guidelines as appropriate based upon their clinical judgement. In situations when needed, the CRC will also be expected to identify and support the needs of the potential donor family and offer them information about donation opportunities (organ and tissue). After authorization is obtained, the CRC will coordinate the transport of blood for serological testing and tissue typing to the appropriate laboratories. They will also initiate individualized case donor management, after brain death is declared, to ensure donor stability while coordinating arrival of procurement transplant coordinator (PTC) or critical care transport (CCT) to donor's location. Donor management could include ordering and interpreting labs, ensuring appropriate fluid maintenance, and implementing vasoactive and hemodynamic supportive medications as required by the donor's status. They will obtain required information from the hospital medical record to be transferred with patients from the donor hospital location to the donor recovery center as appropriate.
The Clinical Response Coordinator will also be able to perform specific partner services activities as directed by their supervisor. Those responsibilities may include but not be limited to: rounding through units to build relationships, presenting information/outcomes to hospital staff members in both formal and informal settings, and participating in education about donor suitability, brain death testing, specific donation processes, etc. This position requires 12-15 days of 24-hour call per month.
Position Requirements:
EDUCATION AND EXPERIENCE:
Required: Associate's degree in a medical or related field and one (1) year of experience in nursing, as an EMT, Paramedic, Respiratory Therapist, Social Worker, or experience in the donation industry required. Work experience may substitute for education requirement.
Preferred: Hospital experience, crisis intervention, and/or grief support.
.
LICENSE, CERTIFICATION AND/OR REGISTRATION:
Required: Valid driver's license and ability to be insured.
Preferred: Currently licensed/certified as a Nurse, Emergency Medical Technician (EMT), Paramedic, Respiratory Therapist, Social Worker, or related.
TRAITS & SKILLS: Must be self-directed / self-motivated; must have good communication and interpersonal skills. Must be able to: (1) perform a variety of duties often changing from one task to another of a different nature without loss of efficiency or composure; (2) accept responsibility for the direction, control and planning of an one's own work; (3) work independently and on a flexible schedule; (4) recognize the rights and responsibilities of patient confidentiality; (5) convey empathy and compassion to those experiencing pain, physical or emotional distress and/or grief; (6) relate to others in a manner which creates a sense of teamwork and cooperation; (7) communicate effectively with people from every socioeconomic, cultural and educational background; (8) exhibit flexibility and cope effectively in an ever-changing, fast-paced healthcare environment; (9) perform effectively when confronted with emergency, critical, unusual or dangerous situations; (10) demonstrate the quality work ethic of doing the right thing the right way; and (11) maintain a customer focus and strive to satisfy the customer's perceived needs.
UA Health Services Foundation (UAHSF) is proud to be an AA/EOE/M/F/Vet/Disabled employer.
Physical Therapy Clinic Coordinator
Clinical research coordinator job in Florence, AL
Primary Responsibilities/Requirements:
Must have a degree from an accredited Physical or Occupational Therapy Program
Must have a current Physical Therapy License in the state of Alabama
Must be CPR Certified
Must be able to use arms, hands and fingers skillfully
Frequent use of forceful exertion during treatment
Frequent moving, pushing, pulling of heavy patients and/or equipment
Constant standing and walking
Must be agile and able to work efficiently in space limited areas
Consistently work at a productive pace
Must readily adapt to frequent treatment schedule changes
Must be capable of directing staff in a way to ensure an engaging environment for staff and patients that aligns with the goals and mission of TOC
Responsible for overseeing daily operations of clinic staff including insuring proper staffing to cover patient census, updating performance reviews at scheduled intervals, approving time cards and verifying hours worked/time off taken, and working with Therapy Director and Office Manager to hire therapists and scheduling staff, as well as aide positions in certain locations
Regularly order supplies for the clinic or work with the supply department to ensure clinic is appropriately covered for wound care, cleaning, and general office supplies
Responsible for addressing any employee or patient matters on site as they arise. They will also work closely with HR and the Director of Therapy in cases where more action is required
Must also possess:
Ability to work under pressure
Outstanding organizational, verbal and writing skills
Independent and highly motivated
Initiative and self-discipline
Proven positive, "teamwork" attitude in work history
Position requirements:
Required Education:
Physical or Occupational Therapy degree from an accredited Physical Therapy Program
Required License/Certification:
Current Physical Therapy license in the State of Alabama.
Clinical Coordinator (RN)
Clinical research coordinator job in Red Bay, AL
Job Description
The Clinical Coordinator is a highly responsible position that is accountable to the Director of Nursing. This position promotes maximum deliverance of quality of care and quality of life by identifying and resolving clinical problems, issues and providing appropriate training to the nursing staff.
Qualifications:
Must be a graduate of an accredited school of nursing and licensed as an RN in the state of Alabama.
Must have at least two (2) years of nursing experience in a clinical setting and at least one (1) year of experience as a supervisor in a long-term care facility.
Must demonstrate knowledge and skills to provide care appropriate to the needs of the residents served.
Must possess leadership and supervisory ability and the willingness to work as a supportive team member with and supervise nursing personnel.
Possess the ability to plan, organize, develop, implement and interpret the programs, goals, objectives, policies and procedures necessary for providing quality care.
Job Duties:
Ensure medical equipment required is available and set up in the resident's room prior to admission.
Assessment of new and/or readmissions upon arrival to the facility.
Perform daily rounds with Nursing Team Leaders to identify any changes in a resident's condition.
Review Nurse's Notes to ensure proper documentation relating to residents treatments, medications and conditions.
Admit, transfer and discharge residents as necessary.
Monitor residents' treatments and medications to ensure residents are receiving proper care.
Attend department head meetings and nurse management meetings as directed by the Administrator and/or Director or Nursing.
Job Posted by ApplicantPro
Temporary Clinical Associate (May 2026)
Clinical research coordinator job in Jacksonville, AL
Department:
Nursing
Salary:
$30.00 per hour (Max 26 hours per week)
Normal Work Schedule:
Varies depending on department need and clinical schedule
Job Summary:
This is professional nursing work in assisting the faculty of the School of Health Professions and Wellness in preparing and presenting material to nursing students. This position is responsible for assisting faculty in instructing and evaluating students and provides individual assistance to students when required.
Duties and Responsibilities:
Coordinates with clinical activities as directed.
Promotes an effective clinical learning environment.
Assists in providing clinical resources to enhance learning.
Participates in the assessment of student progress in relation to course objectives and clinical activities.
Coordinates resources, equipment and supplies available in the College Laboratory and Nursing Center Clinic.
Assesses, plans, implements and evaluates creative laboratory experiences under the direction of nursing faculty.
Establishes and maintains equipment necessary for college laboratory experiences.
Demonstrates effective interpersonal relationships.
Performs other duties as assigned.
Required Minimum Qualifications:
Bachelor's degree in Nursing is required.
Current licensure with the Alabama Board of Nursing.
Current liability insurance.
Required Documents:
Cover Letter
Resume
Unofficial Transcript
Clery Notice: In compliance with the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act, ******************************************************* the Jacksonville State University Police provide information on crimes statistics, crime prevention, law enforcement, crime reporting, and other related issues for the past three calendar years. The JSU Annual Campus Security and Fire Report is available online at: *****************************************************
Equal Employment Opportunity: Jax State is an Equal Employment and Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, genetic information, national origin, disability status, protected veteran status, or any other characteristic protected by law.