regulatory coordinator

Virginia Commonwealth University

<div><div><div><ul><li>45001868
</li></ul></div><div><ul><li>907 Floyd Avenue, MCV Main Campus, Virginia, United States, 23284
</li></ul></div><div><ul><li>SVP Health Sciences SML
</li></ul></div><div><ul><li>Research
</li></ul></div><div><ul><li>Staff
</li></ul></div><div><ul><li>Virginia Commonwealth University</li></ul></div></div><div> 
</div><div>Advertising Summary: Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU&rsquo;s sponsored research, the School of Medicine is internationally recognized for patient care and education. Virginia Commonwealth University is an equal opportunity employer.

Unit: School Of Medicine MBU

Department: Pauley Heart Center

Department Summary:

Founded more than 20 years ago, the Pauley Heart Center is today the top-ranked heart center in Virginia, and one of only a handful of named heart centers in the nation. Headquartered at VCU Health in Richmond with outpatient centers throughout central and southeast Virginia, Pauley provides clinical services and community education and outreach programs throughout the region.

Cardiovascular disease (CVD) is the leading cause of death nationwide and in Virginia, and despite advances in prevention and treatment in recent decades, CVD disproportionately affects individuals with poor social determinants of health. Pauley's mission is to improve cardiovascular care and reduce health disparities for all through interdisciplinary, cutting-edge, clinical, translational and community-based research; training and developing the next generation of cardiovascular clinicians and researchers across all levels of education; and providing innovative and accessible cardiovascular procedural care (both surgical and catheter-based) that is the best in the Commonwealth. Pauley is a regional and national leader in research, education, and clinical programs involving electrophysiology; advanced cardiac imaging (MRI, CT, echo); advanced heart failure, including device-based treatments, total artificial heart, and heart transplant programs; cardio-oncology; high-risk percutaneous coronary interventions; adult congenital heart disease; and exercise-based cardiovascular disease prevention. Pauley also operates top-flight sub-specialty clinics and research programs investigating cardiac amyloidosis; cardiac sarcoidosis; and hypertrophic cardiomyopathy.

Position Summary: To serve in the key role of Regulatory Affairs Coordinator which will facilitate the successful launch and oversight of clinical research studies at Pauley Heart Center/Division of Cardiology Virginia Commonwealth University. This position supports pre-award, regulatory, and start-up activities to ensure that all institutional, sponsor, and federal requirements are met efficiently and accurately. Working in close collaboration with investigators, research teams, and administrative offices, the coordinator facilitates study activation from proposal development through study initiation, helping to reduce start-up timelines and maintain regulatory compliance. This role is ideal for a detail-oriented professional who thrives in a collaborative environment and is motivated to streamline research processes that advance the Pauley Heart Center mission.

This is a restricted position with no set end date continued employment is dependent upon project need, availability of funding, and performance.

Core Responsibilities:

Research Regulatory and Compliance Coordination (60%)
<ul>
<li>Complete and/or support Pauley Heart Center and Cardiology Divisional research staff with the development and submission of documents to applicable regulatory agencies from study start up through completion (local and central IRBs, varying local committees, FDA, etc.)</li>
<li>Research and provide best applicable regulatory pathways for investigator initiated trials, including drug and device studies</li>
<li>Ensure compliance with FDA, NIH, and institutional regulations related to human subjects protection, Good Clinical Practice (GCP), and data security</li>
<li>Provide support for and/or develop essential trial documents as needed for research projects and trials (protocols, ICFs, scripts, DCFs, data management plans, etc.).</li>
<li>Track renewals, amendments, and continuing reviews to ensure ongoing compliance and study continuity</li>
<li>Assesses and reports problems with study protocol and/or consent form compliance and intervenes appropriately</li>
<li>Other duties as assigned related to research regulatory and compliance</li>
</ul>
Pre-award Coordination (40%)
<ul>
<li>Assist faculty and study teams with preparation, review, and submission of grant and contract proposals including review of funding announcements</li>
<li>Ensure pre-award materials meet all VCU, sponsor, and federal guidelines</li>
<li>Coordinate internal routing and approval processes (RAMS-SPOT, Proposal Central, etc.) and ensure timely submission of proposals</li>
<li>Coordinate with research finance and contracting offices to ensure budgets and scopes of work reflect regulatory and compliance requirements</li>
<li>Track pre-award timelines and communicate updates to principal investigators and departmental/center leadership</li>
<li>Collaborate with Division of Sponsored Programs (DSP) and departmental research administrators on budget revisions, just-in-time submissions, and funding notifications</li>
<li>Other duties as assigned related to pre-award support</li>
</ul>
Qualifications:

Minimum Hiring Standards:
<ul><li>Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.</li>
<li>Knowledge of research development, execution, and administration.</li>
<li>Excellent written, oral and interpersonal communication skills. Meticulous attention to detail for comprehension of nuanced regulations.</li>
<li>Ability to manage multiple projects, multi-task and prioritize autonomously. Able to work in a fast paced, demanding environment and adapt to changing client status, regulations and work environment.</li>
<li>Demonstrated knowledge of medical terminology. Demonstrated proficiency with multiple computer applications, including but not limited to: MS Word, MS Excel, spreadsheet management, PDF file creation/use, online database use.</li>
<li>Requires analytical skills to resolve problems that require the use of basic scientific, mathematical or technical principles.</li>
</ul>
Required Education and Experience:
<ul>
<li>Bachelor&rsquo;s degree or relevant experience in a healthcare or academic research setting</li>
<li>Must maintain appropriate certifications and trainings (e.g., CITI Human Subjects, GCP)</li>
<li>Ability to work in a fast-paced, demanding, and diverse environment and adapt to changing client status, regulations, and work environment</li>
<li>Demonstrated knowledge of medical terminology</li>
<li>Excellent discretionary decision-making and problem-solving skills</li>
<li>Independent, self-motivated, and organized</li>
<li>Excellent written, verbal, and interpersonal skills</li>
</ul>
Preferred Qualifications
<ul>
<li>2+ years of experience in regulatory affairs for clinical research (especially in cardiovascular, translational, or academic medical center context)</li>
<li>Experience with human subject research participants</li>
<li>Experience with regulatory submissions/compliance to both local and central IRB&rsquo;s</li>
</ul>
Salary Range: $55,000 - $70,000

Benefits: All full-time university staff are eligible for VCU&rsquo;s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave, generous tuition benefits, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more.

FLSA Exemption Status: Exempt 
 
Hours per Week: 40

Restricted Position: Yes

ORP Eligible: No

Flexible Work Arrangement: Hybrid

University Job Title: 3411B - Clinical Research Coordinator Base

Contact Information: 
Contact Name: Cheyenne Taylor 
Contact Email: Cheyenne.Taylor@vcuhealth.org</div></div>

Clinical Research Regulatory Coordinator, School of Medicine/Internal Medicine/Cardiology

<div><div><div><div><div><ul><li>45001868
</li></ul></div><div><ul><li>907 Floyd Avenue, MCV Main Campus, Virginia, United States, 23284
</li></ul></div><div><ul><li>Research
</li></ul></div><div><ul><li>Staff
</li></ul></div><div><ul><li>School Of Medicine MBU</li></ul></div></div><div> 
</div><div>Advertising Summary: Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU&rsquo;s sponsored research, the School of Medicine is internationally recognized for patient care and education. Virginia Commonwealth University is an equal opportunity employer.

Unit: School Of Medicine MBU

Department: Pauley Heart Center

Department Summary:

Founded more than 20 years ago, the Pauley Heart Center is today the top-ranked heart center in Virginia, and one of only a handful of named heart centers in the nation. Headquartered at VCU Health in Richmond with outpatient centers throughout central and southeast Virginia, Pauley provides clinical services and community education and outreach programs throughout the region.

Cardiovascular disease (CVD) is the leading cause of death nationwide and in Virginia, and despite advances in prevention and treatment in recent decades, CVD disproportionately affects individuals with poor social determinants of health. Pauley's mission is to improve cardiovascular care and reduce health disparities for all through interdisciplinary, cutting-edge, clinical, translational and community-based research; training and developing the next generation of cardiovascular clinicians and researchers across all levels of education; and providing innovative and accessible cardiovascular procedural care (both surgical and catheter-based) that is the best in the Commonwealth. Pauley is a regional and national leader in research, education, and clinical programs involving electrophysiology; advanced cardiac imaging (MRI, CT, echo); advanced heart failure, including device-based treatments, total artificial heart, and heart transplant programs; cardio-oncology; high-risk percutaneous coronary interventions; adult congenital heart disease; and exercise-based cardiovascular disease prevention. Pauley also operates top-flight sub-specialty clinics and research programs investigating cardiac amyloidosis; cardiac sarcoidosis; and hypertrophic cardiomyopathy.

Position Summary: To serve in the key role of Regulatory Affairs Coordinator which will facilitate the successful launch and oversight of clinical research studies at Pauley Heart Center/Division of Cardiology Virginia Commonwealth University. This position supports pre-award, regulatory, and start-up activities to ensure that all institutional, sponsor, and federal requirements are met efficiently and accurately. Working in close collaboration with investigators, research teams, and administrative offices, the coordinator facilitates study activation from proposal development through study initiation, helping to reduce start-up timelines and maintain regulatory compliance. This role is ideal for a detail-oriented professional who thrives in a collaborative environment and is motivated to streamline research processes that advance the Pauley Heart Center mission.

This is a restricted position with no set end date continued employment is dependent upon project need, availability of funding, and performance.

Core Responsibilities:

Research Regulatory and Compliance Coordination (60%)
<ul>
<li>Complete and/or support Pauley Heart Center and Cardiology Divisional research staff with the development and submission of documents to applicable regulatory agencies from study start up through completion (local and central IRBs, varying local committees, FDA, etc.)</li>
<li>Research and provide best applicable regulatory pathways for investigator initiated trials, including drug and device studies</li>
<li>Ensure compliance with FDA, NIH, and institutional regulations related to human subjects protection, Good Clinical Practice (GCP), and data security</li>
<li>Provide support for and/or develop essential trial documents as needed for research projects and trials (protocols, ICFs, scripts, DCFs, data management plans, etc.).</li>
<li>Track renewals, amendments, and continuing reviews to ensure ongoing compliance and study continuity</li>
<li>Assesses and reports problems with study protocol and/or consent form compliance and intervenes appropriately</li>
<li>Other duties as assigned related to research regulatory and compliance</li>
</ul>
Pre-award Coordination (40%)
<ul>
<li>Assist faculty and study teams with preparation, review, and submission of grant and contract proposals including review of funding announcements</li>
<li>Ensure pre-award materials meet all VCU, sponsor, and federal guidelines</li>
<li>Coordinate internal routing and approval processes (RAMS-SPOT, Proposal Central, etc.) and ensure timely submission of proposals</li>
<li>Coordinate with research finance and contracting offices to ensure budgets and scopes of work reflect regulatory and compliance requirements</li>
<li>Track pre-award timelines and communicate updates to principal investigators and departmental/center leadership</li>
<li>Collaborate with Division of Sponsored Programs (DSP) and departmental research administrators on budget revisions, just-in-time submissions, and funding notifications</li>
<li>Other duties as assigned related to pre-award support</li>
</ul>
Qualifications:

Minimum Hiring Standards:
<ul><li>Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.</li>
<li>Knowledge of research development, execution, and administration.</li>
<li>Excellent written, oral and interpersonal communication skills. Meticulous attention to detail for comprehension of nuanced regulations.</li>
<li>Ability to manage multiple projects, multi-task and prioritize autonomously. Able to work in a fast paced, demanding environment and adapt to changing client status, regulations and work environment.</li>
<li>Demonstrated knowledge of medical terminology. Demonstrated proficiency with multiple computer applications, including but not limited to: MS Word, MS Excel, spreadsheet management, PDF file creation/use, online database use.</li>
<li>Requires analytical skills to resolve problems that require the use of basic scientific, mathematical or technical principles.</li>
</ul>
Required Education and Experience:
<ul>
<li>Bachelor&rsquo;s degree or relevant experience in a healthcare or academic research setting</li>
<li>Must maintain appropriate certifications and trainings (e.g., CITI Human Subjects, GCP)</li>
<li>Ability to work in a fast-paced, demanding, and diverse environment and adapt to changing client status, regulations, and work environment</li>
<li>Demonstrated knowledge of medical terminology</li>
<li>Excellent discretionary decision-making and problem-solving skills</li>
<li>Independent, self-motivated, and organized</li>
<li>Excellent written, verbal, and interpersonal skills</li>
</ul>
Preferred Qualifications
<ul>
<li>2+ years of experience in regulatory affairs for clinical research (especially in cardiovascular, translational, or academic medical center context)</li>
<li>Experience with human subject research participants</li>
<li>Experience with regulatory submissions/compliance to both local and central IRB&rsquo;s</li>
</ul>
Salary Range: $55,000 - $70,000

Benefits: All full-time university staff are eligible for VCU&rsquo;s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave, generous tuition benefits, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more.

FLSA Exemption Status: Exempt 
 
Hours per Week: 40

Restricted Position: Yes

ORP Eligible: No

Flexible Work Arrangement: Hybrid

University Job Title: 3411B - Clinical Research Coordinator Base

Contact Information: 
Contact Name: Cheyenne Taylor 
Contact Email: Cheyenne.Taylor@vcuhealth.org</div></div></div></div>

TAQWA PHARMA

We are seeking a highly organized and detail-oriented Program Coordinator to manage the complete operational and regulatory workflow of our healthcare access program. This role is strictly compliance-based and operational in nature; it does not involve direct selling, sales target achievement, or demand generation. The ideal candidate will be the central operational point of contact ensuring smooth regulatory approvals, documentation, and supply chain tracking.Key Responsibilities:<ul><li>Registration Management: Manage the end-to-end registration process for partnering hospitals and medical consultants.</li><li>Regulatory Compliance: Oversee the processing and securing of No Objection Certificates (NOCs) through the Drug Regulatory Authority of Pakistan (DRAP) and maintain all necessary regulatory documentation.</li><li>Financial Operations: Coordinate payment processing with finance department and ensure the timely submission of final banking documentation for import/clearance purposes.</li><li>Supply Chain Tracking: Handle pre-clearance procedures, monitor shipment statuses, and ensure accurate delivery tracking to the final destination.</li><li>Workflow Coordination: Actively follow up with internal teams, regulatory bodies, and external partners to prevent delays and ensure strict compliance with program guidelines.</li></ul>Required Skills &amp; Qualifications:<ul><li>Communication: Excellent verbal and written communication skills to effectively interact with consultants, banks, and regulatory authorities.</li><li>Technical Proficiency: Highly proficient in Microsoft Office (Excel, Word, PowerPoint) and professional email correspondence.</li><li>Time Management: Strong ability to prioritize tasks, meet strict regulatory deadlines, and manage time effectively.</li><li>Follow-Up &amp; Diligence: Exceptional follow-up skills with a proactive approach to resolving operational bottlenecks.</li><li>Prior experience in pharmaceutical administration, regulatory affairs, or supply chain operations is highly preferred.</li></ul>Location : Near Karachi Chamber of Commerce &amp; IndustryPay: Rs40,000.00 - Rs70,000.00 per monthEducation:<ul><li>Bachelor's (Required)</li></ul>Work Location: In person

Patient Program Coordinator

GS Aduanera LLC

Job Title: Customs CoordinatorCompany: GS Aduanera LLC Location: Doha, QatarPosition SummaryGS Aduanera LLC is seeking a detail-oriented and proactive Customs Coordinator to manage and support customs clearance operations in compliance with Qatar customs regulations. The role ensures smooth import and export processing, accurate documentation, and timely coordination with freight forwarders, customs authorities, and internal departments.Key Responsibilities<ul><li>Prepare, review, and process import and export customs documentation in compliance with Qatari customs laws and procedures.</li><li>Coordinate customs clearance activities with freight forwarders, shipping lines, and customs authorities.</li><li>Ensure proper classification of goods using HS codes and verify applicable duties and taxes.</li><li>Monitor shipment status and resolve any customs-related delays or issues.</li><li>Maintain accurate records of all customs transactions and documentation for audit purposes.</li><li>Liaise with internal teams (logistics, procurement, finance) to ensure smooth cargo flow.</li><li>Stay updated on changes in customs regulations and trade compliance requirements in Qatar.</li><li>Support in the preparation of customs reports and documentation for management review.</li><li>Assist in managing duty exemptions, temporary imports, and special customs regimes when applicable.</li><li>Ensure compliance with company policies and international trade regulations.</li></ul>Requirements<ul><li>Bachelor&rsquo;s degree in Logistics, Supply Chain Management, Business Administration, or related field.</li><li>2&ndash;4 years of experience in customs clearance or freight forwarding (GCC experience preferred).</li><li>Strong knowledge of Qatar Customs procedures and HS classification system.</li><li>Familiarity with import/export documentation and Incoterms.</li><li>Proficiency in MS Office and customs/trade systems (e.g., Single Window platforms if applicable).</li><li>Strong organizational and problem-solving skills.</li><li>Ability to work under pressure and meet tight deadlines.</li><li>Good communication skills in English (Arabic is an advantage).</li></ul>Preferred Skills<ul><li>Experience in dealing with customs brokers and government authorities.</li><li>Knowledge of duty drawback and customs compliance audits.</li><li>Attention to detail with high accuracy in documentation.</li></ul>What We Offer<ul><li>Competitive salary package</li><li>Professional growth opportunities in logistics and trade compliance</li><li>Dynamic and multicultural work environment in Doha</li></ul>الراتب المدفوع: QAR٠٫٠٠&nbsp;لكل عامموقع العمل: بشكل شخصي

Customs Coordinator

Ju Group of Companies

Relationship Officer (OGRA Coordination) - (Males Only)Department: Compliance / Regulatory AffairsReports To: Head of Department/DirectorsLocation: IslamabadQualification: Minimum GraduationMarket Competitive Salary +Medical+Annual Bonus+ BenefitsJob Purpose:To manage all correspondence with the Oil and Gas Regulatory Authority (OGRA), including drafting, reviewing, replying, and timely submission of official letters, ensuring compliance with regulatory requirements.Key Responsibilities:&Oslash; Draft professional letters, applications, and responses to OGRA in line with regulatory standards.&Oslash; Review incoming OGRA communications and prepare appropriate replies within deadlines.&Oslash; Ensure timely submission of documents, reports, and correspondence to OGRA.&Oslash; Maintain proper record and filing (hard &amp; soft copies) of all OGRA-related communications.&Oslash; Coordinate with internal departments to gather required information/data for OGRA submissions.&Oslash; Track deadlines and ensure compliance with OGRA requirements and directives.&Oslash; Follow up with OGRA officials regarding submitted applications, approvals, and queries.&Oslash; Ensure accuracy, clarity, and professionalism in all official communications.&Oslash; Assist in preparing compliance reports and regulatory documentation.Qualifications:Bachelor&rsquo;s degree in Business Administration, or relevant field.2&ndash;3 years of experience in regulatory coordination.Skills &amp; Competencies:&Oslash; Strong letter drafting and business communication skills&Oslash; Good understanding of regulatory/compliance processes&Oslash; Attention to detail and accuracy&Oslash; Time management and deadline handling&Oslash; Proficiency in MS Office (Word, Excel, Outlook)&Oslash; Ability to coordinate with multiple departmentsPreferred Experience:&Oslash; Experience dealing with OGRA or other regulatory authorities&Oslash; Knowledge of oil &amp; gas sector regulationsDrop your cv at hr@jugroupofcompanies.com or whatsapp your cv : +92 326 8007056Job Type: Full-timePay: From Rs60,000.00 per monthWork Location: In personApplication Deadline: 15/05/2026

Relationship Officer (OGRA Coordination)

Intercoastal Medical Group

<div>About Company:
Founded in 1993, Intercoastal Medical Group is an association of more than 100 highly credentialed physicians encompassing many medical specialties serving Sarasota County and Manatee County, Florida with nine locations. Intercoastal is the premier provider of choice in the Sarasota / Bradenton area.
Intercoastal Medical Group also prides itself on offering this area&rsquo;s most current technology and resources. Extensive laboratory and diagnostic equipment and a day surgery center allow for fast and accurate diagnostic tests and procedures at conveniently located Intercoastal facilities.
We are always looking for qualified and compassionate professionals to join our team of dedicated providers and staff. If you enjoy working in a fast-paced environment where you can truly make a difference in the lives of patients, then Intercoastal Medical Group is the place for you.
About the Role:
The Clinical Research Coordinator II plays a pivotal role in the successful execution and management of clinical research studies within healthcare settings. This position is responsible for coordinating all aspects of clinical trials, ensuring compliance with regulatory requirements, and maintaining the integrity and accuracy of study data. The coordinator will serve as a liaison between investigators, study participants, sponsors, and regulatory bodies to facilitate smooth study operations. They will oversee participant recruitment, informed consent processes, and data collection while monitoring adherence to study protocols. Ultimately, this role contributes to advancing medical knowledge and improving patient care through rigorous clinical research.
Salary will commensurate with research experience and certifications.
Minimum Qualifications:<ul><li>
Bachelor&rsquo;s degree or higher in a health-related field.</li><li>
At least 3 years of experience coordinating clinical research studies in a healthcare or academic setting.</li><li>
Knowledge of clinical research regulations, including FDA, IRB, and GCP guidelines.</li><li>
Strong organizational skills with the ability to manage multiple studies simultaneously.</li><li>
Proficiency in electronic data capture systems and Microsoft Office Suite.</li></ul>
Preferred Qualifications:<ul><li>
Certification as a Clinical Research Coordinator (e.g., ACRP-CRC or SOCRA).</li><li>
Current licensure as a Licensed Practical Nurse or Registered Nurse; or current medical assistant certification</li><li>
Experience with neurology or other specialized therapeutic area clinical trials.</li><li>
Familiarity with statistical software and data analysis techniques.</li><li>
Demonstrated ability to work effectively in multidisciplinary teams and communicate with diverse stakeholders.</li></ul>
Responsibilities:<ul><li>
Coordinate and manage day-to-day activities of clinical research studies, including participant recruitment, screening, enrollment, and follow-up.</li><li>
Ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements such as FDA and IRB guidelines.</li><li>
Maintain accurate and detailed study documentation, including case report forms, regulatory binders, and electronic data capture systems.</li><li>
Collaborate with principal investigators, research staff, and external sponsors to facilitate study progress and resolve any issues.</li><li>
Monitor participant safety and report adverse events promptly according to protocol and regulatory standards.</li><li>
Schedule and conduct study visits, collect biological samples, and administer study-related procedures as required.</li><li>
Assist in the preparation and submission of regulatory documents and study reports.</li><li>
Train and mentor junior research staff and support continuous quality improvement initiatives within the research team.</li></ul>
Skills:
The Clinical Research Coordinator II utilizes strong organizational and communication skills daily to manage complex clinical trial logistics and ensure protocol adherence. Attention to detail is critical when maintaining accurate study documentation and handling regulatory submissions. Proficiency with electronic data capture systems and Microsoft Office tools supports efficient data management and reporting. Interpersonal skills enable effective collaboration with investigators, participants, and sponsors, fostering a cooperative research environment. Additionally, problem-solving abilities are essential to address challenges that arise during study conduct and to implement process improvements.<ul><li>Intercoastal is a drug free workplace and EEO compliant.</li></ul> 
Monday-Friday, 8am-5pm</div>

Clinical Research Coordinator II

AXCES Research Group

We are looking to hire a smart, motivated, and personable bad a$$ Research Coordinator to join our amazing team!The Clinical Research Coordinator (CRC) is responsible for the day‑to‑day coordination and execution of clinical research studies in compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. This role works closely with investigators, participants, sponsors, and regulatory bodies to ensure the successful conduct of clinical trials.Key Responsibilities<ul><li>Coordinate and manage clinical research studies from start‑up through study close‑out</li><li>Screen, recruit, consent, and enroll study participants in accordance with protocol requirements</li><li>Conduct study visits, collect source data, and ensure accurate and timely documentation</li><li>Maintain investigational product binders, essential documents, and study accountability records</li><li>Ensure compliance with study protocols, IRB requirements, GCP, and institutional policies</li><li>Enter and manage data in electronic data capture (EDC) systems</li><li>Coordinate laboratory specimens, imaging, and other study‑related procedures</li><li>Act as a liaison between investigators, study participants, sponsors, CROs, and regulatory authorities</li><li>Prepare for and support monitoring visits, audits, and inspections</li><li>Track study timelines, enrollment metrics, and adverse events</li><li>Assist with study start‑up activities including feasibility assessments and submissions</li></ul>Preferred Qualifications<ul><li>Clinical Research Coordinator certification (e.g., ACRP‑CRC, SOCRA‑CCRP)</li><li>Experience working with IRBs and regulatory submissions</li><li>Phlebotomy, ECG, or other clinical skills (if required for studies)</li><li>Detail-oriented self-starter</li><li>Excellent communication and people skills (bilingual English/Spanish preferred)</li></ul>Up to ~20% Travel may be required for this role.We do exciting and meaningful work - visit us at www.axceshealth.org for more information about what we do. We're looking forward to meeting you!Local applicants onlyPay: $25.00 - $30.00 per hourBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Health insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Work Location: In person

Clinical Research Coordinator

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8143 regulatory coordinator jobs Near Me

Clinical Research Regulatory Coordinator, School of Medicine/Internal Medicine/Cardiology

Clinical Research Regulatory Coordinator, School of Medicine/Internal Medicine/Cardiology

Patient Program Coordinator

Customs Coordinator

Relationship Officer (OGRA Coordination)

Clinical Research Coordinator II

Clinical Research Coordinator