lead clinical research coordinator

MaineHealth

<div>Description
MaineHealth Institute for Research
Nursing 
Req #: 76029
Summary:
This position is for someone interested in joining a hands-on team at the MHIR - MaineHealth Institute for Research, which is contributing to biomedical research in the area of Oncology. Our team is specifically interested in therapeutic trials, testing various combinations of chemotherapy, immunotherapy, targeted therapy, and radiation therapy. This Lead Clinical Research Nurse Coordinator will work at the direction of the Manager, Clinical Trials Office, and will be responsible for all aspects of research coordination, actively pre-screening and enrolling patients, scheduling study assessments, clinical data management, and communication with the study sponsor. This includes collaboration with the Principal Investigator, Program Coordinator, Study Center, and relevant MaineHealth Departments. The primary responsibilities include study coordination and acting as a hospital educator/resource person for studies. The primary characteristics of a successful Lead Clinical Research Nurse Coordinator include supervisory skills, attention to detail, highly organized, and excellent communication skills. This position plays a lead role in training and ongoing operations support of other Clinical Research Nurse Coordinators
 A hybrid work schedule from our Scarborough, Maine location is available for this position. Some reimbursed travel to trial sites in Brunswick and Rockport will be required.
 The MaineHealth application, a cover letter and a resume or CV are all required elements for application to this position.
 Learn more about the MaineHealth Institute for Research in this short video!
Required Minimum Knowledge, Skills, and Abilities (KSAs) 
<ul><li>
Education: Bachelor's Degree in a health science field required. Master&rsquo;s degree preferred.</li><li>
License/Certifications: Current applicable state license as a Registered Nurse required.</li><li>
Experience: Two years of clinical experience in a healthcare setting required.</li></ul>
Hiring Scam Alert
MaineHealth will never request financial information during the interview or pre-hiring process. All legitimate communications will come from an email address ending in @mainehealth.org. If you suspect fraudulent activity, please report it immediately to mhcareers@mainehealth.org. 
Additional Information 
With a career at any of the MaineHealth locations across Maine and New Hampshire, you&rsquo;ll be working with health care professionals that truly value the people around them &ndash; both within the walls of the organization and the communities that surround it. 
 
We offer benefits that support an individual's needs for today and flexibility to plan for tomorrow &ndash; programs such as paid parental leave, a flexible work policy, student loan assistance, training and education, along with well-being resources for you and your family. 
 
MaineHealth remains focused on investing in our care team and developing an inclusive environment where you can thrive and feel supported to realize your full potential. If you&rsquo;re looking to build a career in a place where people help one another deliver best-in-class care, apply today. 
If you have questions about this role, please contact sharon.nightingale@mainehealth.org</div>

Lead Clinical Research Nurse Coordinator (RN)

Tribe Clinical Research

Title: Clinical Research Coordinator
 
Position: Full-Time, Hourly
 
Based at: TCR – Greenville
 
Position Summary: The Clinical Research Coordinator will be primarily responsible for conducting Phase II, III and IV clinical trials within internationally accepted standards of knowledge and understanding of the research process and related regulations. A lead study coordinator will have oversite of assigned clinical trials conducted at Tribe Clinical Research, under the direction of the Primary Investigator and Site Lead. Since this is primarily a customer contact position, it requires an outgoing, friendly personality and someone who enjoys working with a diverse population of people. To understand the inclusion/exclusion requirements of protocols, a strong understanding of medical terminology is required. Strong clinical skills required and computer skills for communication.
 
Key Skills and Competencies: 
<ul>
<li>CMA Certification or willingness to complete</li>
<li>Medical and Clinical Research Terminologies</li>
<li>Excellent verbal, written & interpersonal skills</li>
<li>Exceptional attention to detail and accuracy</li>
<li>Data Management and Informatics</li>
<li>Adherence to Principles of Ethical Research Standards</li>
<li>Highly organized individual</li>
<li>Continuous learning mindset</li>
</ul>
Primary Accountabilities: 
<ul>
<li>Informed Consent Process</li>
<li>Medical Record Review</li>
<li>Protocol compliance/documentation</li>
<li>Patient relations</li>
<li>Sponsor relations/communication</li>
<li>Investigational Product/Drug Administration</li>
</ul>
General Accountabilities: 
<ul>
<li>Collaboration with QA</li>
<li>Trains other clinical trial associates making sure all individuals are up to date on all aspects of a clinical trial.</li>
<li>Oversee organization and workflow of trials with meticulous attention to detail and ordering of priorities.</li>
<li>Navigate and address sponsor and study issues to resolution.</li>
<li>Perform clinical responsibilities, such as blood draws, processing, vaccine administration.</li>
<li>Maintenance of organized, complete study charts, and legible, accurate research documentation through written progress notes.</li>
<li>Have working knowledge of protocol including background, rationale, and description of investigational drug/device.</li>
<li>Thorough knowledge of Inclusion/Exclusion criteria with Investigator available for questions.</li>
<li>Coordinate and document in-service training for appropriate staff.</li>
<li>Submit all regulatory documents and correspondence to regulatory personnel in a timely manner.</li>
<li>Identify protocol problems and inform TCR Research Team of problems limiting recruitment and work on strategies to overcome these problems.</li>
<li>Maintain detailed drug accountability.</li>
<li>Conduct ordering of all protocol required follow-up labs, tests, procedures, and medications accurately and per qualifications and delegation by PI.</li>
<li>Collaborate with attending Investigator and Principal Investigator to report serious adverse events to study sponsor and regulatory personnel within mandated timeframe.</li>
<li>Participate in weekly site meetings.</li>
<li>Communicate with other professionals via phone, email, and face-to-face meetings to make sure the whole clinical trial team is consistently aware of any relevant information and issues.</li>
<li>Ability to communicate effectively both verbally and in writing with advanced interpersonal communication skills. This includes the ability to perform computer-based work on a regular basis.</li>
<li>Knowledge of the research process, the importance of adherence to protocols, and the accuracy needed in collection and documentation of research data.</li>
<li>Ability to read and understand the protocol, including any amendments, to ensure familiarity with study procedures and an understanding of the potential risks and side effects of the investigational product.</li>
<li>Ability to interact daily with physicians, nurses, study monitors and other sponsor representatives, administrators and other employees, community resources, patients and their families and significant others.</li>
</ul>
This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible job responsibilities, tasks, and duties. Responsibilities, tasks, and duties of the job holder might differ from those outlined in the job description and other duties, as assigned, might be part of the job.
 
A person in this position must be highly organized, utilize excellent verbal and written communication and be able to multi-task. This position requires excellent time management and communication skills and confidentiality. This position may require travel, lifting (up to 50 pounds), sitting, standing, and walking associated with a normal clinical research / physician office environment. A person in this position may be exposed to fumes, airborne particles, infectious diseases, blood/bodily fluids, and disease-bearing specimens.
 
This position requires adherence to Tribe Clinical Research’s Core Values as outlined:
 <ul>
<li>We are passionate about working for a GROWTH ORIENTED company.</li>
<li>We exhibit a HUMBLE but CONFIDENT approach to work.</li>
<li>We communicate what needs to be said RESPECTFULLY.</li>
<li>We love serving others and WORKING TOGETHER for the greater good.</li>
<li>We can take constructive feedback well and have a POSITVE ATTITUDE even when the going gets tough.</li>
</ul>
Reporting Structure: Site Lead
 
Tribe Clinical Research is an Equal Opportunity Employer

Clinical - Clinical Research Coordinator

Eximia Clinical Research

Clinical Research CoordinatorEximia Clinical Research is looking for a Clinical Research Coordinator to join our team. As the Clinical Research Coordinator, you will act as the subject matter expert and manage clinical trial(s) from start up through study close out in accordance with the study protocol, GCP, and Eximia Clinical Research&rsquo;s SOPs.Role &amp; Responsibilities:<ul><li>Serve as lead of studies to execute clinical trials</li><li>Train staff in the conduct of clinical trials, protocol requirements, communication,</li></ul>and trial management skills<ul><li>Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines</li></ul>and Eximia Clinical Research&rsquo;s SOPs<ul><li>Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations</li><li>Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable</li><li>Implement and coordinate assigned clinical trials including start up, vendor management,</li></ul>subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, participating in the ICF process(es), conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.<ul><li>Apply project management concepts to manage risk and improve quality in the conduct of a</li></ul>clinical research study<ul><li>Develop, coordinate, and implement research and administrative strategies to successfully</li></ul>manage assigned protocols.<ul><li>Communicate effectively and professionally with coworkers, leadership, study subjects,</li></ul>sponsors, CROs, and vendors.<ul><li>Ensure good documentation in accordance with ALCOA-C principles are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries</li><li>Ensure confidentiality of patient protected health information, sponsor confidential information</li></ul>and Eximia Clinical Research confidential information is maintained by all team members<ul><li>Develop communication and escalation strategies within teams to that ensure patient safety is</li></ul>upheld and all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and Eximia Clinical Research SOPs<ul><li>Develop or contribute to development of tools and training to prepare for and/or participate in site audits and inspections</li><li>Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely</li></ul>manner as set forth in the Clinical Trial Agreement<ul><li>Ensure the creation, collection and submission of regulatory documents to Sponsors and IRBs</li></ul>as required per protocol, GCP/ICH regulations and IRB requirements.<ul><li>Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.</li><li>Incorporate key timelines, endpoints, required vendors, and patient population when planning</li></ul>for each assigned protocol.<ul><li>Incorporate understanding of how decisions affect the bottom-line including links between</li></ul>operations and company&rsquo;s financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol.<ul><li>Incorporate understanding of product development lifecycle and significance of protocol</li></ul>design including critical data points when planning for each assigned protocol<ul><li>Develop Quality Control strategies for team member projects</li><li>Perform clinical duties (e.g. Drug preparation and administration, fibroscan, phlebotomy, ECG,</li></ul>lab processing) within scope<ul><li>Promote respect for cultural diversity and conventions with all individuals.</li><li>Understand the disease process or condition under study</li><li>Other duties as assigned</li></ul>QualificationsEducation/Experience:<ul><li>Bachelor&rsquo;s degree and 6 years as a Clinical Research Coordinator OR</li><li>Associate&rsquo;s degree and 8 years as a Clinical Research Coordinator OR</li><li>High School Graduate and/or technical degree and 10 years as a Clinical Research Coordinator</li></ul>Required Licenses/Certifications:<ul><li>Phlebotomy if applicable and required by state law</li><li>Intravenous/Intramuscular dose administration and preparation if applicable and required by state law</li><li>Certified Clinical Research Coordinator through ACRP or SOCRA within six months of being in the role</li></ul>Required Skills:<ul><li>Advanced knowledge of medical terminology</li><li>Proficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.</li><li>Proficient ability to work in a fast-paced environment</li><li>Advanced verbal, written, and organizational skills</li><li>Advanced interpersonal and communication skills</li><li>Advanced ability to work as a team player</li><li>Advanced ability to read, write, and speak English</li><li>Demonstrated ability to multi-task</li><li>Advanced ability to follow written guidelines</li><li>Demonstrated ability to work independently, plan and prioritize multiple deliverables and objectives</li><li>Demonstrated ability to be flexible/adapt as daily schedule may change rapidly</li><li>Must be detail oriented</li><li>Proficient problem solving and strategic decision making ability.</li><li>Advanced in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised.</li><li>Proficient leader, mentor and team builder</li></ul>Required Physical Abilities:<ul><li>Sit or stand for long periods of time</li><li>Communicate in person and by telephone</li><li>Limited to moderate walking</li><li>Limited lifting up to 30 pound</li></ul>Job Type: Full-timePay: $55,000.00 - $62,000.00 per yearBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Employee assistance program</li><li>Flexible spending account</li><li>Health insurance</li><li>Health savings account</li><li>Life insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Work Location: In person

Clinical Research Coordinator

AMR Clinical

<div>The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study. 
To consistently embody AMR Clinical&rsquo;s Core Values:<ul><li>
United We Achieve</li><li>
Celebrate Diverse Perspectives</li><li>
Do the Right Thing</li><li>
Adapt and Persevere</li></ul>
The Clinical Research Coordinator reports to the Site Manager/Team Lead.
Classification: Non-Exempt
Primary Responsibilities:<ul><li>
Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent. Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures.</li><li>
Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols.</li><li>
Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution.</li><li>
Establish understanding of SOP&rsquo;s and implement the SOP&rsquo;s</li><li>
Gain understanding of the pharmaceutical drug per clinical trial.</li><li>
Develop detailed knowledge of protocol and procedures per clinical research study.</li><li>
Communicate effectively with study sponsors, CROs, monitors/CRA&rsquo;s, IRBs, laboratories, and clinical personnel within the research industry.</li><li>
Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study.</li><li>
Establish and maintain patient rapport.</li><li>
Clinical data collection (vital signs, EKG recording, weight, height, etc.)</li><li>
Obtain medical records and review as required.</li><li>
Phlebotomy</li><li>
Specimen collection, processing, and storage</li><li>
Transporting clinical specimens to the laboratory.</li><li>
Educate subjects on diaries and oversees compliance with diary completion.</li><li>
Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.)</li><li>
Responsible for completing patient phone call visits in accordance to the standard protocol period.</li><li>
Ensure documentation follows ALCOA standards and is completed in a timely manner.</li><li>
Ensure all necessary documents are completed, signed and dated.</li></ul><ul><li>
Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required.</li><li>
Manage study inventory and order supplies as needed.</li><li>
Prepare and assist study monitors during onsite visits.</li></ul><ul><li>
 Maintain familiarity with all ongoing clinical research studies.</li><li>
Travel to Investigator meetings as needed.</li><li>
Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties</li><li>
Position may require occasional weekend and/or overtime hours.</li><li>
Other duties as assigned</li></ul> 
Desired Skills and Qualifications:<ul><li>
1 year of experience in clinical research.</li><li>
Completion of formal medical training, educational program, or healthcare experience</li><li>
Strong medical terminology</li><li>
Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.).</li><li>
Ability to work independently and lead study-related tasks.</li><li>
Ability to multi-task in a high-paced evolving environment.</li><li>
Exceptional listening, written, and verbal communication skills as well.</li><li>
Demonstrate proficiency in office equipment and software programs.</li><li>
Excellent organizational and task management skills.</li><li>
Ability to be ambulatory most of the workday.</li><li>
Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.</li></ul> 
AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.
** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.</div>

Clinical Research Coordinator 1

Rheumatology Office Alex DeJesus, MD

Clinical Research Coordinator <ul><li>Location Houston, Tx</li></ul>1 years of Experience requiredJob Description Clinical Research Coordinator (CRCs) Clinical Research Coordinator will work in a team environment under the Leadership of the investigator with supervision of the Research Director or Team Lead.Job Purpose: To promote good clinical practice in the conduct of clinical investigations. The Coordinator must possess an in depth knowledge of federal regulations to conduct clinical trials and protect human subject. One must be able to assure compliance with protocol and regulatory requirements, by collecting, recording and maintaining data and source documentation.Participates in Subject Recruitment, Enrollment and Follow up Procedures By: <ul><li>Integrating proposed clinical trial with current research activities</li><li>Attending and participating in investigator meetings</li><li>Listing and clarifying questions and concerns with the sponsor and investigator regarding enrollment goals sponsor expectations and study procedures</li><li>Monitoring enrollment goals and modifying recruitment plan as necessary</li><li>Maintaining patient screening/enrollment logs</li><li>Reviewing inclusion/exclusion criteria with investigator to assure subject eligibility</li><li>Reviewing and verifying source documents in subject&rsquo;s medical record to confirm subject&rsquo;s eligibility assuring that all screening, eligibility and enrollment procedures are performed</li><li>Reviewing the protocol, informed consent form and follow up procedure with potential study subjects</li><li>Conducting interviews at assess the subject&rsquo;s ability and willingness to follow and complete study procedures and visits</li><li>Obtaining informed consent from research subjects prior to any study related procedures and documenting appropriately</li><li>Following randomization procedures as per protocol</li><li>Dispensing study article as appropriate</li><li>Scheduling subject&rsquo;s follow up visits</li><li>Reviewing diaries and questionnaires completed by subjects</li><li>Ensuring appropriate specimen collection, batching and shipping as required</li><li>Assessing subject compliance with the test article and follow up visits</li></ul>Protects Subjects Confidentiality By:<ul><li>Protecting patient privacy during initial and follow up interviews</li><li>Documenting protocol deviations and exemptions</li><li>Obtaining/reviewing original source documents</li><li>Abstracting data from medical records to clinic, consultation and referral notes to study forms and flow sheets</li><li>Recording accurate and timely data onto case report forms</li><li>Maintaining source documentation for all case report entries as applicable</li><li>Keying data for electronic submission</li><li>Transmitting data via fax, mail or electronically as requested</li><li>Correcting and editing case report form entries as appropriate</li><li>Resolving data queries</li><li>Completing and maintaining the study article dispensing log</li><li>Maintaining files of all study related documentation</li><li>Recognizing and reporting common laboratory values and alerts to investigator and sponsor</li></ul>Participates in Monitoring Visits and Audits By:<ul><li>Scheduling sponsor monitoring visits</li><li>Ensuring that EDC for Sponsor company is done within 3 business days and is correct</li><li>Collecting source documents for sponsor/audit review</li><li>Meeting with monitors/auditors during routine visits to discuss case report form completion, query resolution and other protocol related issues</li><li>Preparing for and participating in FDA inspections as needed</li></ul>Maintains Professional and Technical KnowledgeBy:<ul><li>Attending educational workshops</li><li>Reviewing professional publications</li></ul>Job Type: Full-timePay: $37,941.00 - $55,091.00 per yearBenefits:<ul><li>Dental insurance</li><li>Health insurance</li><li>Life insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Experience:<ul><li>Pharmaceutical research: 1 year (Required)</li></ul>Language:<ul><li> Fluent Spanish (Required)</li></ul>Ability to Commute:<ul><li>Houston, TX 77089 (Required)</li></ul>Work Location: In person

Clinical Research Coordinator 1 yr. exp req.

Premiere Health and Wellness

Lead Clinical Research Coordinator Job DescriptionJob Title: Lead Clinical Research CoordinatorReports To: Clinical Research Site ManagerDepartment: Clinical OperationsLocation: On-site (SKYCRNG Network Site)Position SummaryThe Lead Clinical Research Coordinator (Lead CRC) provides operational leadership and oversight of clinical research studies conducted at the site. This role is responsible for ensuring protocol compliance, subject visit execution, investigational product (IP) accountability, regulatory maintenance, and serving as a DEXA technician, while serving as a manager to CRCs. The Lead CRC works closely with the Site Manager to support study start-up, execution, study maintenance, and close-out activities in accordance with ICH-GCP, IRB requirements, sponsor protocols, and SKYCRNG&rsquo;s Standard Operating Procedures (SOPs).Key ResponsibilitiesStudy Operations &amp; Compliance<ul><li>Maintain and oversee subject visit schedules, ensuring protocol-required visits and procedures are completed accurately and on time.</li><li>Ensure subject visit compliance across all CRCs, including source documentation, protocol adherence, and timely data, imaging, and lab query resolution by CRC staff.</li><li>Oversee and maintain investigational product (IP) accountability, ensuring accurate documentation, storage, reconciliation, and compliance.</li><li>Maintain the regulatory binder, ensuring all essential documents are complete, current, and audit-ready.</li><li>Attend and actively participate in Site Initiation Visits (SIVs) and other required sponsor or CRO meetings.</li></ul>Data Quality &amp; Query Management<ul><li>Oversee the resolution of data, lab, and imaging queries, ensuring timely, accurate responses and appropriate follow-up.</li><li>Collaborate with CRCs to identify trends, recurring errors, or training needs related to source quality and visit compliance.</li><li>Provide ongoing subject study status updates to the Site Manager, including enrollment, visit completion, and outstanding issues.</li></ul>Study Start-Up &amp; Close-Out &amp; Systems Readiness<ul><li>Work closely with the Site Manager to collect, organize, and submit study start-up documents, including regulatory and training materials.</li><li>Create and maintain study-specific checklists to support efficient study execution and consistent CRC workflows.</li><li>Complete continuing review and study termination IRB submissions in accordance with IRB requirements and established timelines.</li></ul>Leadership, Mentorship &amp; Team Development<ul><li>Serve as a manager and subject-matter resource for CRCs, providing guidance on protocol requirements, documentation standards, and best practices.</li><li>Support training, onboarding, and professional development of CRC staff.</li><li>Ensure all site staff have appropriate access to study systems, including EDC, IRT/IXRS, ePRO, imaging platforms, and sponsor portals.</li><li>Monitor and support staff training completion, system access readiness, and protocol-required certifications.</li><li>Promote a culture of compliance, accountability, collaboration, and continuous improvement across the site and SKYCRNG network.</li></ul>&middot;DEXA &amp; Specialized Procedure Oversight<ul><li>Perform and/or coordinate DEXA scans, including the completion, tracking, and documentation of all outside DEXA scans, as required per protocol.</li></ul>QualificationsRequired<ul><li>Minimum 3&ndash;5 years of clinical research coordination experience.</li><li>Strong working knowledge of ICH-GCP, IRB requirements, and FDA regulations.</li><li>Proven experience with regulatory binders, IP accountability, and subject visit management.</li><li>Experience working with EDC systems, IRB portals, and sponsor systems.</li><li>Excellent organizational, communication, and leadership skills.</li></ul>Preferred<ul><li>Prior experience in a Lead CRC or Senior CRC role.</li><li>Experience with DEXA scans and imaging-based clinical studies.</li><li>Multi-protocol and multi-therapeutic area experience.</li><li>Professional certification (CCRC, CCRP, or equivalent).</li></ul>Core Competencies<ul><li>Attention to detail and regulatory compliance</li><li>Leadership and team mentorship</li><li>Time management and prioritization</li><li>Data quality oversight and query resolution</li><li>Cross-functional collaboration</li><li>Audit and inspection readiness</li></ul>Work Environment<ul><li>Clinical research site environment</li><li>May require extended hours based on study needs and sponsor visits</li><li>Occasional travel for meetings, monitoring visits, or training, if applicable</li></ul>SKYCRNG is committed to excellence, integrity, and community-focused research. This role is critical to maintaining our reputation as an audit-ready, enrollment-ready, high-performing clinical research network.Job Type: Full-timeWork Location: In person

<div>The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study. 
To consistently embody AMR Clinical&rsquo;s Core Values:<ul><li>
United We Achieve</li><li>
Celebrate Diverse Perspectives</li><li>
Do the Right Thing</li><li>
Adapt and Persevere</li></ul>
The Clinical Research Coordinator reports to the Site Manager/Team Lead.
Classification: Non-Exempt
Primary Responsibilities:<ul><li>
Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent. Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures.</li><li>
Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols.</li><li>
Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution.</li><li>
Establish understanding of SOP&rsquo;s and implement the SOP&rsquo;s</li><li>
Gain understanding of the pharmaceutical drug per clinical trial.</li><li>
Develop detailed knowledge of protocol and procedures per clinical research study.</li><li>
Communicate effectively with study sponsors, CROs, monitors/CRA&rsquo;s, IRBs, laboratories, and clinical personnel within the research industry.</li><li>
Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study.</li><li>
Establish and maintain patient rapport.</li><li>
Clinical data collection (vital signs, EKG recording, weight, height, etc.)</li><li>
Obtain medical records and review as required.</li><li>
Phlebotomy</li><li>
Specimen collection, processing, and storage</li><li>
Transporting clinical specimens to the laboratory.</li><li>
Educate subjects on diaries and oversees compliance with diary completion.</li><li>
Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.)</li><li>
Responsible for completing patient phone call visits in accordance to the standard protocol period.</li><li>
Ensure documentation follows ALCOA standards and is completed in a timely manner.</li><li>
Ensure all necessary documents are completed, signed and dated.</li></ul><ul><li>
Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required.</li><li>
Manage study inventory and order supplies as needed.</li><li>
Prepare and assist study monitors during onsite visits.</li></ul><ul><li>
 Maintain familiarity with all ongoing clinical research studies.</li><li>
Travel to Investigator meetings as needed.</li><li>
Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties</li><li>
Position may require occasional weekend and/or overtime hours.</li><li>
Other duties as assigned</li></ul> 
Desired Skills and Qualifications:<ul><li>
Licensed RN or LPN</li><li>
1 year of experience in clinical research.</li><li>
Completion of formal medical training, educational program, or healthcare experience</li><li>
Strong medical terminology</li><li>
Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.).</li><li>
Ability to work independently and lead study-related tasks.</li><li>
Ability to multi-task in a high-paced evolving environment.</li><li>
Exceptional listening, written, and verbal communication skills as well.</li><li>
Demonstrate proficiency in office equipment and software programs.</li><li>
Excellent organizational and task management skills.</li><li>
Ability to be ambulatory most of the workday.</li><li>
Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.</li><li>
Fluent in English.</li></ul> 
AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.
** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.</div>

Clinical Research Coordinator/ LPN-RN

Search 10000+ Lead clinical research coordinator jobs near you this May. New roles added regularly across leading industries. Apply today.

10000 lead clinical research coordinator jobs Near Me

Lead Clinical Research Nurse Coordinator (RN)

Clinical - Clinical Research Coordinator

Clinical Research Coordinator

Clinical Research Coordinator 1

Clinical Research Coordinator 1 yr. exp req.

Clinical Research Coordinator

Clinical Research Coordinator/ LPN-RN