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Clinical research coordinator jobs in Alabama

- 33 jobs
  • Pre-Clinical Scientist

    Orano

    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.
    $93k-120k yearly est. 49d ago
  • Senior Clinical Research Coordinator/Sr. DHS - Alabama 10.3.25

    N-Power Medicine

    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.
    $41k-62k yearly est. Auto-Apply 60d+ ago
  • Study Coordinator

    Southern Research Institute 4.3company rating

    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.
    $44k-58k yearly est. 60d+ ago
  • Sr. Clinical Research Associate - FSP

    Parexel 4.5company rating

    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.
    $75k-97k yearly est. 9d ago
  • Study Coordinator, Manager

    RPM Research 4.5company rating

    Clinical research coordinator job in Birmingham, AL

    Job Description Manager, Study Coordination & Quality Control Join a team driven by science, powered by people, and committed to improving lives. A GLP public CRO is seeking an experienced and passionate Manager, Study Coordination & Quality Control, to lead its Preclinical Operations team. In this critical leadership role, you will oversee project execution, ensure quality excellence, and mentor a talented group of Study Coordinators and Quality Control Specialists. If you thrive in a collaborative, fast-paced environment and have a strong commitment to scientific rigor and operational precision, we'd love to meet you. About the Role As the Manager of Study Coordination & QC, you will guide day-to-day operations, champion quality excellence, and empower your team to deliver project outcomes that are on time, within budget, and compliant with all standards. Working closely with Study Directors, Project Managers, and other internal partners, you'll ensure seamless planning, execution, and reporting across preclinical studies. You will play an instrumental role in optimizing workflows, monitoring financial impact, enhancing cross-functional processes, and elevating the quality of deliverables. This is an opportunity to create meaningful impact-from shaping departmental procedures to supporting studies that advance scientific innovation. Key Responsibilities Team Leadership & Development Lead, mentor, and develop a high-performing team of Study Coordinators and QC staff. Provide daily work direction, coaching, performance feedback, and career development. Foster a diverse, collaborative, and trust-centered team environment. Operational Execution Oversee study coordination activities from project initiation through reporting. Collaborate with Project Managers, Study Directors, and internal stakeholders to support costing, scheduling, tracking, and reporting. Ensure all work is completed accurately, on time, and within budget. Maintain operational calendars and oversee Provantis data collection software usage and data extraction. Quality Oversight Monitor end-to-end process quality; develop and track quality metrics across operations. Review protocols, amendments, and reports for accuracy and compliance. Participate in pre-study and post-project evaluations, identifying opportunities for improvement. Strategic & Administrative Contributions Participate in departmental budgeting and workload projections. Identify staffing needs; support recruitment, hiring, and performance management. Develop and maintain SOPs to ensure alignment with current practices. Promote safety standards and uphold strong business ethics. Qualifications Bachelor's degree required. Minimum 5 years of study coordination and QC experience in a preclinical or related scientific environment. Ability to meet medical and safety requirements (including required vaccinations). Proven leadership skills, strong communication abilities, and a commitment to operational excellence. What We Value Our core values shape how we work and how we lead: Cultivating Human Connection We put people first and believe in the power of trust, inclusion, and courageous teamwork. Operating with Precise Execution We leverage data, remain agile, take ownership of results, and treat feedback as an opportunity to grow. Harnessing Relentless Curiosity We ask sharp questions, push scientific boundaries, and continuously innovate. Stewarding a Healthy Community We prioritize safety, sustainability, dignity, and equitable opportunities for employees, customers, and communities alike. Behavioral & Leadership Expectations Build and maintain a high-trust, high-performance team. Communicate clearly and with impact across diverse audiences. Coach and develop others, recognizing achievements and addressing challenges promptly. Plan effectively, stay organized, and consistently deliver operational excellence. Work Environment This role includes work in both office and laboratory settings and requires the use of PPE, completion of medical evaluations, and the ability to receive experimental vaccines as required. Ready to Make an Impact? If you are driven by purpose, inspired by scientific progress, and energized by leading teams toward excellence, we encourage you to apply.
    $38k-53k yearly est. 2d ago
  • Clinical Research Coordinator

    Gastro Health 4.5company rating

    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!
    $50k-64k yearly est. 22d ago
  • Research Coordinator

    Allervie Health

    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.
    $37k-54k yearly est. 54d ago
  • Assistant Research Coordinator

    Rehabilitation and Neurological Service, LLC

    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.
    $37k-54k yearly est. 18d ago
  • Primary Health Clinical Research Study Operations Coordinator

    Cahaba Medical Care Foundation 3.0company rating

    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.
    $40k-52k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Coordinator II

    Objectivehealth 3.7company rating

    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.
    $41k-59k yearly est. 60d+ ago
  • Clinical Research Coordinator

    No-Resistance Consulting Group

    Clinical research coordinator job in Birmingham, 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
    $25 hourly 2d ago
  • Clinical Research Associate II

    Allen Spolden

    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
    $51k-81k yearly est. 60d+ ago
  • Clinical Response Coordinator - Legacy of Hope

    Uahsf

    Clinical research coordinator job in Montgomery, 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.
    $40k-56k yearly est. 60d+ ago
  • Physical Therapy Clinic Coordinator

    The Orthopaedic Center 4.2company rating

    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.
    $46k-58k yearly est. 60d+ ago
  • Clinical Coordinator (RN)

    Generations of Red Bay

    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
    $40k-56k yearly est. 7d ago
  • Temporary Clinical Associate (May 2026)

    Department of Human Resources 3.8company rating

    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.
    $30 hourly 60d+ ago
  • Senior Clinical Research Associate/Clinical Research Associate II - Oncology - US - FSP

    Parexel 4.5company rating

    Clinical research coordinator job in Montgomery, AL

    **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and + recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
    $75k-97k yearly est. 12d ago
  • Clinical Research Coordinator/DHS II - Alabama 10.3.25

    N-Power Medicine

    Clinical research coordinator job in Alabama

    About N-Power Medicine N-Power Medicine aims to establish a new paradigm in drug development by reinventing the ‘how' and transforming clinical trials through better integration with clinical practice, ensuring broader participation by physicians and patients. We are building an exceptional multi-disciplinary team with diverse expertise spanning healthcare, engineering, technology and regulatory, and with people who share our core value of Empowering Community through generosity, curiosity and humility. We are working with urgency to bring better therapies to patients faster. Position Summary You will be a part of the rapidly changing clinical oncology environment with the opportunity to impact the future of clinical research and improve patients' lives while growing professionally at a dynamic, fast-growing, start-up organization. As the Digital Health Specialist II (internal title), you will work at a clinical site in either Tuscaloosa and/or Anniston, Alabama. The ideal candidate has clinical oncology research experience or research experience in a healthcare setting. You are confident in your understanding of clinical workflow, patient data systems and clinical research in an oncology setting. We are looking for individuals who are motivated and ambitious professionals who desire to positively influence and innovate upon the quality of care for patients diagnosed with cancer. Roles and Responsibilities Serve as the Company's trusted face to the clinical practice, providing clinical support while advancing research data collection. Interface directly with the healthcare providers and patients. Perform peer review of clinical documentation for data quality and completeness. Partner with Senior DHS to address any clinic or team issues and concerns. Obtain informed consent for N-Power Medicine's clinical trials. Assist and participate in the site clinical trial initiation and clinical trial(s) activities as assigned. Ensure adherence to study protocols, data completeness and patient consent. Assist in patient recruitment strategies where appropriate. Foster collaborative relationships by effectively communicating with clinical site staff, internal stakeholders, and the N-Power Medicine team by attending site specific meetings. Build and maintain relationships at the clinical site, becoming part of the functional team of practitioners. Ensure quality and integrity of data capture, compliance and confidentiality with N-Power Medicine's and site's policies, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Respond to queries regarding missing, aberrant, or potential outlier data and data verification- escalate to the health care provider as necessary for resolution. Provide proactive input and user experiences for our software. Additional duties and responsibilities as required. Generous, curious and humble. Qualifications 3+ years of experience in oncology clinical research and/or oncology ambulatory care preferred Bachelor's degree, focused in health science or related field preferred Certified Clinical Research Coordinator, Associate or Professional (CCRC, CCRA or CCRP) preferred Knowledge of clinical trials, study-specific operating procedures and patient consent forms Strong desire to drive a paradigm change in clinical research conduct and improve patients' lives Compassionate focused patient care Supports and encourages other team members, contributing to a positive team environment Self-starter, able to work independently, prioritize actively, seek input, and problem solve in complex and fast-evolving environments Results oriented focused on delivering the goals set-forth Attention to detail and strong organizational skills Excellent oral/written communication and interpersonal skills Critical thinking and proven problem-solving skills Work hours are dependent on local Network Partner Clinics (typically M-F, 8-5pm) Please note that state-specific background checks and screenings may be required for this role. Employment is contingent upon successfully passing all applicable screenings. Travel Requirements Daily travel between sites may be required $99,000 - $149,000 a year The expected salary range for this position is $99,000 and $149,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. N-Power Medicine (NPM) offers equity at hire as well as a discretionary annual bonus which may be available based on Company performance. This position is eligible for company benefits. More About UsWe are a mission driven, well -funded, rapidly growing company, eager to attract passionate professionals offering a highly attractive compensation package with a balanced and flexible work environment, competitive industry benefits as well as a 401K plan and other great company “perks.” We are an Equal Opportunity Employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Covid-19 Policy - The Company is committed to providing and maintaining a safe workplace, and to safeguard the health and well-being of our employees, families, visitors, and the community. While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary. We currently do not have mandatory COVID-19 vaccination requirements for our employees and contractors, as the COVID-19 public health emergency has ended. However, there are certain N-Power Medicine employees and contractors who, based on their role, will be required to continue to follow our 2021 COVID-19 vaccination and other requirements as mandated by N-Power Medicine's partners they serve. We reserve the right to modify or amend our corporate policy at any time. Applicants must be currently authorized to work in the U.S. on a full-time basis. The Company will not sponsor applicants for work visas. If you find this opportunity compelling, we encourage you to apply today! We promptly review all applications. Highly qualified candidates will be directly contacted by a team member. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
    $39k-56k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Coordinator

    No-Resistance Consulting Group

    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!
    $25 hourly 17d ago
  • Clinical Response Coordinator - Legacy of Hope - Huntsville

    Uahsf

    Clinical research coordinator job in Huntsville, AL

    Schedule: Shifts Can 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.
    $40k-56k yearly est. 27d ago

Learn more about clinical research coordinator jobs

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What are the top employers for clinical research coordinator in AL?

No-Resistance Consulting Group

Cahaba Medical Care

N-Power Medicine

Top 5 Clinical Research Coordinator companies in AL

  1. No-Resistance Consulting Group

  2. ObjectiveHealth

  3. Gastro Health

  4. Cahaba Medical Care

  5. N-Power Medicine

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