clinical study coordinator

CenExel Clinical Research

<div>About Us:
Each of CenExel&rsquo;s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.

Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Job Summary:
Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.

Compensation: $26.09 $33.32/hr (Depending on education, experience, and skillset)

Essential Responsibilities and Duties:
<ul>
<li>Assists with coordinating all aspects of patient involvement from study initiation until study completion.</li>
<li>Organizes research information for clinical trials.</li>
<li>Observes subjects and assists with data analysis and reporting.</li>
<li>Schedules the collection of data.</li>
<li>Documents adverse events, protocol deviations, and other unanticipated problems appropriately.</li>
<li>Reports research data to maintain quality and compliance.</li>
<li>Performs administrative and regulatory duties related to the study as appropriate.</li>
<li>Participates in other protocol development activities.</li>
<li>Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)</li>
<li>Educates potential participants and caregivers on protocol specific details and expectations.</li>
<li>Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).</li>
<li>Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.</li></ul> 


Education/Experience/Skills:
<ul>
<li>High school graduate or equivalent; Bachelors Degree, preferred.</li>
<li>0-3 years of experience in the medical field.</li>
<li>Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials.</li>
<li>Strong leadership and mentorship skills.</li>
<li>Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level.</li>
<li>Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.</li>
<li>Works independently as well as functioning as part of a team.</li>
<li>Must be able to effectively communicate verbally and in writing.</li></ul> 


Working Conditions
<div><ul><li>Indoor, Office environment.</li></ul>
<ul><li>Shift work, depending on location.</li></ul>
<ul><li>Essential physical requirements include sitting, typing, standing, and walking.</li></ul>
<ul><li>Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds.</li></ul>
<ul><li>Reporting to work, as scheduled, is essential.</li></ul>
<ul><li>Overnight travel may be required for training and/or investigative meetings.</li></ul></div> 


CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
Equal Opportunity Employer 
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.</div>

Clinical Research Coordinator I

Quotient Sciences

<div>
 
 Quotient Sciences: Molecule to Cure. Fast.
 
 
 
 Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing.
 
 
 Our proprietary and disruptive platform &ndash; &ldquo;Translational Pharmaceutics&reg;&rdquo; &ndash; integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn
 
 reduces costs
 
 , improves outcomes, and significantly accelerates drug development times.
 
 
 
 Why Join Us
 
 
 
 Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact&mdash;fast.
 
 
 
 The Role
 
 
 
 <ul>
 <li>
 Responsible to provide administrative support for the Project Management group and to lead the study review activities and communications on allocated projects
 </li>
 <li>
 To comply &amp; adhere to GCP guidelines and regulations as required of this role
 
 
 </li>
 </ul>
 
 Main Tasks And Responsibilities
 
 
 
 <ul>
 <li>
 Assist in the preparation and formatting of study documentation, including informed consent forms, source documents, and client deliverables.
 </li>
 <li>
 Establish and maintain study files, including Trial Master Files (TMF) in both electronic and paper formats.
 </li>
 <li>
 Maintain delegation logs by coordinating with internal teams to ensure accuracy and timely updates for new and terminated staff.
 </li>
 <li>
 Maintain training logs and ensure training compliance for all personnel listed on delegation logs.
 </li>
 <li>
 Manage file note control, including creation, review, and filing.
 </li>
 <li>
 Ensure all regulatory documentation is audit-ready and compliant with archiving requirements.
 </li>
 <li>
 Support study review board submissions by uploading administrative documents, study updates, and required correspondence.
 </li>
 <li>
 Process Spanish regulatory documents and communicate approvals to the screening team.
 </li>
 <li>
 Notify staff of updated or newly released documents via secure file systems.
 </li>
 <li>
 Support the Project Management team with PSA activities, revenue forecasting, and invoicing.
 </li>
 <li>
 Assist with study closeout activities, including budget reconciliation and archiving.
 </li>
 <li>
 Maintain and perform quality control (QC) of the volunteer clinical RSVP database.
 </li>
 <li>
 Manage laboratory requisitions and collaborate with Data Management to support query resolution.
 </li>
 <li>
 Support eSource User Acceptance Testing (UAT) activities.
 </li>
 <li>
 Assist with the hosting and support of sponsor monitors during site visits and with related action items
 
 
 </li>
 </ul>
 
 Job Demands
 
 
 
 <ul>
 <li>
 The job may involve the following:
 </li>
 <ul>
 <li>
 Very high concentration of work
 </li>
 <li>
 Strict and tight deadlines
 </li>
 <li>
 Having to juggle a range of tasks/issues simultaneously
 </li>
 <li>
 Working in a hazardous environment with high requirement to follow safety procedures
 </li>
 <li>
 Working outside normal working hours
 </li>
 <li>
 Needing to respond to client demands
 
 </li>
 </ul>
 </ul>
 
 The Candidate
 
 
 
 <ul>
 <li>
 Minimum Degree qualification or equivalent
 </li>
 <li>
 Relevant work experience in a pharmaceutical company/CRO would be an advantage
 </li>
 <li>
 Computer literate, proficient in Microsoft Windows
 </li>
 <li>
 Proficient in Information Technology
 </li>
 <li>
 Highly organized and efficient
 </li>
 <li>
 Ability to communicate effectively; people-oriented personality
 
 
 </li>
 </ul>
 
 Application Requirements
 
 
 
 When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
 
 
 
 Our Commitment to Diversity, Equity and Inclusion
 
 
 
 Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.
 
 
 Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.
 
 
 This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
</div>

Clinical Trial Administrator

Amavita Heart and Vascular

Senior Clinical Research CoordinatorJob Category: HealthcareLocation: North Miami Beach, FLJob Type: Contract 1099, Full-time RoleSchedule: Full-time | Monday&ndash;Friday, 8:00 a.m.&ndash;4:30 p.m.Compensation: $60,000 &ndash; $80,000 annually (commensurate with experience) + bonus eligibilityAbout UsAmavita Research Services, LLC is a high-volume, Cardiovascular research center recognized for excellence in clinical trials with direct access to Advanced Cardiovascular of Miami &mdash; South Florida's only dedicated cardiovascular and interventional-radiology ambulatory surgery center. A next-generation cath lab built for advanced same-day procedures. We partner with leading sponsors and CROs to bring innovative therapies to patients while upholding the highest standards of regulatory compliance and patient safety.We are seeking a dedicated Senior Clinical Research Coordinator to join our team in a contractor role. The role of the Senior Clinical Research Coordinator is of great importance within our team and is an essential part of our organization. As a Senior Clinical Research Coordinator you should have with extensive clinical research experience. While cardiovascular expertise is preferred, it is not mandatory. The ideal candidate will independently manage the day-to-day trial conduct from activation through close-out, overseeing subject visits, data capture, compliance, and mentoring of junior staff..If you thrive in a fast-paced environment and possess a strong desire to learn and grow continuously, our organization is the perfect place for you. Join our team and embrace the exciting journey of professional development!Key Responsibilities:<ul><li>Serve as the primary coordinator for multiple concurrent clinical trials (industry and investigator-initiated).</li><li>Oversee subjects&rsquo; screening, informed consent, study assessments, and AE/SAE reporting according to protocol requirements.</li><li>Perform study procedures, such as ECGs and venipuncture/IV placement, laboratory samples processing, support with devices studies in cath lab and ensure proper accountability of investigational products or devices.</li><li>Enter data into the Electronic Data Capture (EDC) system (e.g., Medidata Rave, Medrio, Oracle Cloud) and resolve queries in a timely manner.</li><li>Coordinate sponsor/CRO monitoring visits and FDA audits, and assist in responding to findings and implementing CAPAs.</li><li>Track study metrics&mdash;including enrollment, retention, and protocol deviations&mdash;and support accurate contract billing compliance.</li><li>Train and mentor junior coordinators, and provide support to the Principal Investigator and sub-investigators.</li></ul>Required Qualifications.<ul><li>Degree in Nursing, Medicine, or a related medical field (a solid medical background is required)</li><li>Extensive hands-on coordination of clinical trials with demonstrated mastery of Good Clinical Practice (GCP), HIPAA, and FDA regulations.</li><li>Proficiency in electronic regulatory platforms and EDC systems.</li><li>Current BLS certification; ACLS certification is a plus.</li><li>Excellent communication skills and ability to interact effectively with sponsors, CROs, and regulatory authorities.</li><li>Ability to work on-site in North Miami Beach, FL; occasional travel to investigator meetings as needed.</li><li>Cardiovascular research experience is preferred but not required.</li></ul>Compensation &amp; Benefits:<ul><li>This is a 1099 independent contractor position, offering competitive compensation between $60,000 and $80,000 annually, plus performance-based bonus opportunities.</li><li>While traditional employee benefits (such as health insurance or 401(k)) are not provided, additional compensation or stipends may be negotiated based on project requirements.</li><li>Flexible work arrangements with on-site responsibilities in North Miami Beach, FL, and potential for professional growth through additional assignments or contract extensions.</li></ul>How to Apply:Please submit your r&eacute;sum&eacute;/CV and a brief cover letter via Indeed or email to [*HR@YourOrg.com]* with the subject line &ldquo;Senior Clinical Research Coordinator Application.&rdquo; Applications will be considered based on relevant clinical research experience.Pay: $60,000.00 - $80,000.00 per yearBenefits:<ul><li>Flexible schedule</li></ul>Work Location: In person

Senior Clinical Research Coordinator

Teak Research Consults

Teak Research Consults specializes in Phase II- IV with two locations in Lawrenceville and Dunwoody GAJob Summary The Clinical Trials Coordinator is responsible for the day‑to‑day execution of clinical research activities in accordance with study protocols, Good Clinical Practice (GCP), and regulatory requirements. With a minimum of three years of hands‑on clinical trial coordination experience, this role ensures the smooth conduct of study visits, accurate documentation, timely data entry, and effective communication with participants, investigators, and study sponsors. The coordinator supports all operational aspects of assigned studies&mdash;including screening, enrollment, visit management, safety reporting, and regulatory compliance&mdash;while maintaining high standards of professionalism, organization, and participant care. This position requires strong attention to detail, the ability to manage multiple priorities, and a commitment to supporting high‑quality clinical research.Responsibilities<ul><li>Coordinate all aspects of clinical trials, ensuring adherence to protocols and regulatory guidelines.</li><li>Monitor patient progress and safety throughout the study, including conducting vital signs assessments and managing patient documentation.</li><li>Review and maintain accurate documentation related to clinical trials, including data collection and management.</li><li>Collaborate with cross-functional teams to ensure compliance with FDA regulations and standards.</li><li>Handling, packaging, and shipping of processed lab samples</li><li>Handling, storing, and processing study drug</li><li>Creating source document</li><li>Conduct patient recruitment, screening, and informed consent processes while adhering to HIPAA regulations.</li><li>Manage clinical laboratory activities, including blood sampling and phlebotomy as required by the study protocols.</li><li>Ensure proper training of staff on clinical trial procedures and compliance management.</li><li>Informed consenting process</li><li>Screening of research patient to determine eligibility</li><li>Vast Knowledge in electronic Clinical Outcome Assessment</li></ul>Qualifications<ul><li>3+ years research experience</li><li>Associates/ Bachelor's degree in a scientific, health related (preffered) or relevant experience in lieu of education</li><li>Strong background in clinical trials management with knowledge of Good Clinical Practice (GCP).</li><li>Familiarity with medical terminology, FDA regulations, and compliance requirements.</li><li>Experience in documentation review, patient monitoring, data collection, and data management.</li><li>Proficiency in using electronic medical record (EMR) systems and statistical software for data analysis.</li><li>Skills in phlebotomy and blood sampling techniques.</li><li>Excellent analytical skills with the ability to interpret complex data sets effectively.</li><li>Knowledge of clinical development processes and the ability to work collaboratively within a research setting. This role is essential for advancing clinical research initiatives while ensuring the highest standards of patient care and regulatory compliance.</li><li>Good communication, organization, and interpersonal skills</li><li>Good computer skills including working knowledge of a PC and Microsoft office</li><li>In depth knowledge of state and federal Regulatory guidelines related to research</li><li>Applicants residing in the Atlanta area are strongly preferred.</li></ul>Job Types: Part-time, ContractPay: From $24.00 per hourBenefits:<ul><li>Referral program</li></ul>Education:<ul><li>Bachelor's (Required)</li></ul>Experience:<ul><li>Clinical research: 3 years (Required)</li><li>Clinical trials management: 3 years (Preferred)</li></ul>Ability to Commute:<ul><li>Lawrenceville, GA 30043 (Required)</li></ul>Work Location: In person

Clinical Trials Coordinator

Pinnacle Clinical Research

<div><div>Summary: The Clinical Research Coordinator will manage the day-to-day operations of assigned clinical trials and ensure that pre-established work scope, study protocol, and regulatory requirements are followed. They will recruit and screen study participants, document and report on the daily operations of a study, and report on participant status. This person must be able to understand clinical trial priorities and establish a workflow to complete all required activities promptly. This position is responsible for a broad range of duties involving confidential information. Strong communication and organizational skills are essential, along with a proactive, problem-solving mindset.</div><div></div><div> 
The Clinical Research Coordinator must be organized, excel at multi-tasking, detail-oriented, an excellent communicator, and be able to provide high-quality participant care. This person will collaborate very closely with other members of the team, pharmaceutical sponsors, and external vendors, and, therefore, must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, initiative-taking, a team player, and able to manage multiple projects effectively and efficiently. This role reports directly to the Clinical Operations Manager.</div><div></div><div> 
Duties and Responsibilities:</div><div></div><div> 
Clinical Trial Execution:</div><ul><li>
Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator, Operations Manager, and Site Director or Regional Director</li><li>
Maintain participant privacy and data confidentiality, complying with the appropriate sponsor requirements and regulations, which include the FDA, ICH GCP, HIPAA, institutional review board determinations, and institutional policies and procedures</li><li>
Complete study-directed assessments with participants, which may include, but are not limited to, informed consent, medical history, adverse events, Fibroscan, memory screen, test article handling, appointment scheduling, records review, treatment coordination, and collecting vital signs</li><li>
Complete documentation and data management-related tasks as instructed by supervisor and compliance leadership in accordance with GCP and other regulatory guidelines</li><li>
Function as a liaison with pharmaceutical sponsors and external vendors, including but not limited to, participating in monitoring visits and audits</li><li>
Responsible for participant management and engagement from the recruitment of study participants to study completion, as applicable.</li><li>
Respond to internal and external requests for information promptly</li><li>
Identify opportunities to improve participant care and satisfaction</li><li>
With a solutions-oriented and collaborative mindset, resolve study-related challenges within a reasonable time set by the supervisor</li><li>
Establish, develop, and maintain productive relationships with internal and external personnel to achieve a high standard of research outcomes.</li><li>
Coordinate multiple projects with competing priorities and deadlines as needed, based on clinical trial protocol directives and study volume</li><li>
Attends the investigator&rsquo;s meeting, pre-study site visit, study initiation visit, and all other study-related visits hosted by monitors or sponsor representatives as appropriate</li><li>
Track enrollment status reports to ensure study sites stay on track to meet enrollment goals</li><li>
Track study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status is kept current</li></ul><div> 
 Administration:</div><ul><li>
Create memos, emails, and letters related to study activities</li><li>
Create and maintain reports and/or spreadsheets as requested</li><li>
Assist regulatory personnel in maintaining study documents and ensure electronic regulatory documents are saved and uploaded appropriately</li><li>
Responsible for reporting safety information to regulatory agencies</li><li>
Perform quality checks on source documents specific to the study</li><li>
Assist with the Corrective and Preventive Action Plan (CAPA) process as needed</li></ul><div></div><div> 
Duties, responsibilities, and activities may change, or new ones may be assigned at any time.</div><div></div><div> 
Education / Experience:</div><ul><li>
High school diploma or general education degree (GED) required</li><li>
Bachelor&rsquo;s Degree in a scientific area of study preferred or equivalent combination of education, training, and experience</li><li>
1 year of experience as a Clinical Research Assistant or Coordinator</li><li>
1-2 years of experience in Clinical Research</li><li>
Proficient in all Microsoft Office applications and Clinical Research IO (CRIO) or equivalent CTMS</li><li>
Must have strong knowledge of ICH/GCP guidelines</li><li>
Must complete GCP training before interacting with participants and must recertify every 2 years or as applicable</li><li>
Trained and certified in the administration of Fibroscan and memory screens as required by the study portfolio and individual experience. Training to be provided</li><li>
Must have basic life support (BLS) training, provided during onboarding</li><li>
Demonstrated organizational skills and outstanding time management, including keen attention to detail, with the ability to track multiple projects at one time</li><li>
Strong written and oral communication skills</li><li>
Knowledge of basic medical terminology</li><li>
Possess impeccable integrity and personal and professional values that are consistent with PCR&rsquo;s high standards and mission</li><li>
Comply with the company policies, code of ethics, and guiding values always</li><li>
Proficient in Spanish and English preferred</li></ul><div></div><div> 
Supervisory Responsibilities: None</div><div> 
</div><div>Certificates and Licenses: Valid Driver&rsquo;s License</div><div></div><div> 
Knowledge, Skills, and Other Abilities:</div><div><ul><li>
Must be able to effectively communicate with all levels of internal and external contacts</li><li>
Demonstrated ability to manage a high-volume workload with multiple clinical trials while maintaining accuracy and compliance.</li><li>
Ability to work independently and multitask in a fast-paced team environment</li><li>
Strong people skills, including the ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and judgment</li><li>
Must possess a positive, friendly, and professional demeanor, particularly when interacting with research participants</li><li>
Must be able to work independently and collaborate with a team</li><li>
Ability to interpret clinical research protocols</li><li>
Strong problem-solving and decision-making skills, particularly when under pressure</li><li>
Proactive at identifying, addressing, and solving issues in real time</li><li>
Energetic self-starter, results-oriented, and able to work effectively in an entrepreneurial environment</li></ul></div><div></div><div> 
Work Environment and Physical Demands:</div><div>
The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.</div><div><ul><li>
Work is performed in an office/laboratory and/or a clinical environment.</li><li>
Exposure to biological fluids and/or bloodborne pathogens.</li><li>
Personal protective equipment is required, such as protective eyewear, garments, and gloves.</li><li>
Occasional travel may be required, domestic and/or international.</li><li>
Ability to work in an upright and/or stationary position for 6-10 hours per day.</li><li>
Frequent mobility required.</li><li>
Occasional squatting, kneeling, or bending.</li><li>
Light to moderate lifting and carrying (or otherwise moving) objects, including medical equipment, with a maximum lift of 20-50 lbs.</li></ul></div><div></div><div> 
Benefits of working at Summit Pinnacle Clinical Research:</div><div><ul><li>
401k</li><li>
Medical, dental, vision, long-term disability, short-term disability, FSA, and life insurance</li><li>
3 weeks of paid time off</li><li>
14 paid company holidays</li><li>
Scrub uniform voucher (specific positions apply)</li><li>
And more!</li></ul></div><div></div><div> 
Summit Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status, or any other protected Federal, State/Province, or Local status unrelated to the performance of the work involved.</div></div><div></div>

Clinical Research Coordinator

American Oncology Network

<div>Location:
Remote Position
Pay Range:
$57,699.20 - $107,140.80<h1 class="jobSectionHeader">
Job Description Summary:</h1>
The Research Study Activation Coordinator is responsible for facilitating the activation of clinical research studies within a healthcare research network setting. This role ensures that all administrative, regulatory, and operational tasks are completed efficiently to initiate clinical trials in compliance with institutional policies, sponsor requirements, and regulatory standards. The coordinator serves as a liaison between site network, study sponsors, investigators, and internal teams, ensuring seamless study start-up processes
Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.<h1 class="jobSectionHeader">
Primary Key Performance Areas:</h1>
KPA 1 &ndash; Management and Oversight of Study Start-up Activities for Multi-Research Site Network<ul><li>
Effectively manage all tasks related to study feasibility, site readiness, and initiation of clinical trials.</li><li>
Coordinate timely and accurate submission of study-related documents with site and regulatory colleagues.</li><li>
Maintain strict adherence to Good Clinical Practice (GCP), FDA regulations, and other relevant guidelines during study activation.</li><li>
Act as the central point of contact for sponsors, investigators, and internal teams, ensuring effective communication and collaboration throughout the activation process.</li><li>
Provide clear, timely updates on the status of study activation activities to all stakeholders.</li></ul>
KPA 2 &ndash; Provide Contract and Budget Coordination<ul><li>
Facilitate contract negotiations and budget finalizations in collaboration with legal and financial teams.</li><li>
Monitor budget approvals and milestone tracking to ensure alignment with project objectives.</li></ul>
KPA 3 &ndash; Facilitate and Implement Process Improvement<ul><li>
Identify and implement opportunities for improving study activation workflows and reducing inefficiencies.</li><li>
Maintain accurate and comprehensive documentation of all activities in compliance with institutional policies and regulatory requirements.</li><li>
Deliver training sessions to research staff on protocol requirements, regulatory standards, and activation processes.</li><li>
Support team members in developing expertise in clinical trial activation tasks.</li></ul><h1 class="jobSectionHeader">
Position Qualifications/Requirements:</h1>
Education:.<ul><li>
High school education required</li><li>
Bachelor&rsquo;s degree in life sciences, healthcare, or a related field</li></ul>
Certifications/Licenses:<ul><li>
Certification in clinical research (e.g., CCRP, CCRC, or equivalent) preferred</li></ul>
Previous Experience:<ul><li>
Minimum 2-3 years of experience in clinical research or a related field</li><li>
Strong knowledge of clinical trial processes, IRB requirements, and regulatory guidelines</li><li>
Excellent organizational and multitasking skills with a high level of attention to detail.</li><li>
Effective communication and interpersonal skills to collaborate with diverse stakeholders.</li><li>
Proficiency in research management systems and Microsoft Office Suite.</li></ul>
Core Capabilities:<ul><li>
Analysis &amp; Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.</li><li>
Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.</li><li>
Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.</li><li>
Customer Service &amp; Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.</li><li>
Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required.</li><li>
Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.</li><li>
Computer Skills:
<ul><li>Proficiency in MS Office Word, Excel, Power Point, and Outlook required.</li><li>
Prior experience with electronic medical records (EMR) is preferred</li><li>
Prior experience with clinical trial data entry systems (EDC) preferred</li><li>
Prior Clinical Trial Management Systems (CTMS) preferred.</li></ul></li></ul>
Travel: &lt;25%
Standard Core Workdays/Hours: Monday to Friday 8:00 AM &ndash; 5:00 PM.
#LI-Remote</div>

Research Study Activation Coordinator

Medical Advancement Centers of Arizona, LLC

Pay: $55,000.00 - $70,000.00 per yearJob description:Company: MACOA Health Location: Phoenix, AZ Onsite Employment Type: Full Time Compensation: Competitive hourly or salaried rate commensurate with experience Industry: Clinical ResearchWhy Join MACOA Health?At MACOA Health, you will be part of a collaborative, mission-driven team conducting clinical research that directly impacts patient health outcomes. We offer opportunities for professional growth, hands-on experience across multiple therapeutic areas, and flexible work arrangements when possible.This position is ideal for a CRC ready to expand their regulatory and operational expertise, contribute meaningfully to advancing science, and work in an environment that values accuracy, compliance, and compassion.Key Responsibilities<ul><li>Study Conduct &amp; Coordination</li><li>Coordinate all aspects of assigned clinical trials, from screening through study close-out.</li><li>Ensure compliance with ICH-GCP, FDA, and sponsor/CRO protocols.</li><li>Conduct informed consent discussions with participants, ensuring comprehension and documentation per site SOPs.</li><li>Patient &amp; Investigator Support</li><li>Schedule and manage participant study visits, assessments, and follow-up.</li><li>Collect and process biological samples, ECGs, and other clinical procedures as required.</li><li>Maintain strong communication with investigators, participants, and study teams to support safety and adherence.</li><li>Data &amp; Documentation</li><li>Enter data into electronic data capture (EDC) systems in alignment with ALCOA-C+ standards.</li><li>Resolve data queries and ensure CRFs/eCRFs are accurate and complete.</li><li>Maintain source documents and essential records in audit-ready condition.</li><li>Regulatory Compliance</li><li>Prepare, submit, and maintain regulatory documents for IRB/IEC submission, approval, and continuing review.</li><li>Maintain and update the regulatory binder/eReg system, ensuring completeness and compliance with sponsor and federal requirements.</li><li>Track and file safety reports, protocol amendments, updated Investigator Brochures, and informed consent forms.</li><li>Ensure timely reporting of adverse events (AEs/SAEs) and protocol deviations per regulatory guidelines.</li><li>Support site inspections, audits, and monitoring visits by maintaining inspection-readiness.</li><li>Site Operations</li><li>Collaborate with investigators, site staff, and sponsor/CRO representatives to ensure trial milestones are achieved.</li><li>Assist with feasibility, pre-study site qualification, and initiation visits.</li><li>Contribute to recruitment and retention strategies for diverse participant enrollment.</li></ul>Requirements<ul><li>Associate&rsquo;s Degree or Bachelor&rsquo;s degree in Life Sciences, Nursing, or related field, or equivalent clinical experience.</li><li>Minimum of 1-2 years of experience as a Clinical Research Coordinator.</li><li>Strong understanding of ICH-GCP guidelines, FDA regulations, and clinical trial conduct.</li><li>Familiarity with IRB/IEC submissions and regulatory documentation.</li><li>Phlebotomy or specimen handling experience.</li><li>Excellent organizational and communication skills.</li><li>Proficiency with EDC, CTMS, and Microsoft Office Suite.</li></ul>Preferred Qualifications<ul><li>Bilingual in Spanish</li><li>Certification as a Clinical Research Coordinator (ACRP-CCRC or SOCRA-CCRP).</li><li>Experience across multiple therapeutic areas.</li><li>Experience with eRegulatory systems.</li></ul>Job Type: Full-timeBenefits:<ul><li>Dental insurance</li><li>Flexible schedule</li><li>Health insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Education:<ul><li>Associate (Required)</li></ul>Experience:<ul><li>CRC: 1 year (Required)</li></ul>Benefits:<ul><li>Flexible schedule</li><li>Health insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Work Location: In personPay: $55,000.00 - $70,000.00 per yearBenefits:<ul><li>Health insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Work Location: In person

Clinical Research Coordinator Level 1 or 2

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