clinical trial coordinator

Headlands Research

<div><div><p>At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion.</p></div><br>
<p></p>
<p>
 <b>Location:</b> Myrtle Beach, SC | Site Name: Headlands Research - Trial Management Associates | Full-Time | Clinical Research</p>
<p>
Are you an experienced clinical research professional with a passion for advancing medicine? Join a leading, integrated clinical research network dedicated to high-quality data, patient-centered care, and innovation in clinical trials.</p>
<p>
We're seeking a full-time <b>Clinical Research Coordinator</b> (CRC) for our clinical research site located in <b>Myrtle Beach, SC</b>. The CRC will manage and execute Phase I-IV clinical studies in accordance with FDA regulations, GCP/ICH guidelines, and sponsor protocols. This role is ideal for someone who thrives in a fast-paced environment and is eager to make an impact in the clinical research industry.</p><br>
<p></p>
<p><b>
Type:</b> Regular Full-time Employee<br>
<b>Schedule:</b> M-Th 7 AM - 4:30 PM | F: 7:30 AM - 11:30 AM<br>
<b>Location:</b> Onsite in Myrtle Beach, SC (no capabilities for remote or hybrid work)<br>
<b>Reports to:</b> Site Director<br>
<b>Benefits:</b> Our benefits package for full-time employees includes health insurance (medical, dental, and vision), Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA), Paid Time Off (PTO), a variety of disability, accident, and life insurance options, as well as many more.</p><br>
<p></p>
<h2 class="jobSectionHeader"><b>
 </b><b>What We Offer</b></h2>
<ul><li>Competitive pay + annual performance incentives</li>
<li>Medical, dental, and vision insurance</li>
<li>401(k) plan with company match</li>
<li>Paid time off (PTO) and company holidays</li>
<li>A mission-driven culture focused on advancing medicine and improving patient outcomes</li></ul><br>
<p></p>
<h2 class="jobSectionHeader"><b>
 </b><b>Why Join Us?</b></h2>
<p>
You'll be part of a growing, mission-driven organization that values its people. At our core, we're committed to bringing innovative medical treatments to patients faster&mdash;while creating an environment where employees thrive. If you're passionate about clinical research and ready to make a difference, we'd love to hear from you.</p><br>
<p></p>
<p></p>
<p><b>Responsibilities:</b></p>
<ul>
<li>Coordinate all aspects of assigned clinical trials from site initiation to study close-out</li>
<li>Conduct subject visits and ensure timely, accurate documentation following ALCOA-C standards</li>
<li>Maintain compliance with study protocols, GCP/ICH guidelines, FDA regulations, IRB policies, and company SOPs</li>
<li>Manage subject recruitment, informed consent, and retention strategies</li>
<li>Ensure timely data entry and resolution of EDC queries</li>
<li>Report and follow up on all adverse events, serious adverse events, and deviations</li>
<li>Collaborate with investigators, lab teams, sponsors/CROs, and internal stakeholders</li>
<li>Prepare for and participate in monitoring visits, audits, and inspections</li>
<li>Maintain regulatory documentation and ensure proper training is completed for all study amendments and systems</li>
<li>Execute study procedures such as phlebotomy, ECGs, and sample processing within scope (as trained)</li>
<li>Attend investigator meetings and provide cross-functional support as needed</li>
<li>Maintain working knowledge of study protocols, laboratory manuals, equipment calibration, and inventory control</li></ul><br>
<p></p>
<p><b>
Requirements:</b></p>
<ul>
<li>Bachelor's degree OR 2 years of college in a health-related program OR experience and training in conducting clinical trials with knowledge of ICH GCP</li>
<li>Previous experience as a Clinical Research Coordinator required</li>
<li>Industry-sponsored trial experience strongly preferred (vaccine study experience a plus)</li>
<li>Familiarity with electronic data capture (EDC), IVRS, and other trial platforms</li>
<li>Deep understanding of FDA, ICH-GCP regulations, and clinical trial procedures</li>
<li>Proficiency in medical terminology and clinical documentation practices</li>
<li>Strong interpersonal, verbal, and written communication skills</li>
<li>Organized, detail-oriented, and capable of managing multiple priorities</li>
<li>Proficient in Microsoft Office and other clinical research systems</li></ul><p></p><div><div><div><br>
<div>
<p></p><div><div><div><div><div><div><div><div><div><p><i>Headlands Research will never ask a candidate for personal identifiable information (date of birth, social security number, driver's license information, etc) via email or messenger tools, or for a financial deposit of any kind.</i></p>
</div>
</div></div></div></div></div><p><i>Headlands Research is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, age, sex, national origin, disability status, genetic information, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.</i></p>
</div>
</div></div></div></div></div><div><div><h3 class="jobSectionHeader"><b>Need Assistance?</b></h3>
<div>
<div><div><div><p><i>Headlands Research is committed to providing access and reasonable accommodation in its employment for individuals with disabilities. To request disability accommodation in the application process, contact </i><i>recruiting@headlandsresearch.com for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.</i></p></div></div></div></div></div></div></div></div><p></p>

Clinical Research Coordinator

LCC Medical Research Institute, LLC

<p><b>Job Overview</b></p><p>We are seeking an experienced Clinical Research Coordinator to join our clinical research team. The ideal candidate must have at least 3 years of clinical research experience and be fully bilingual in English and Spanish. This role requires strong organization, patient communication skills, attention to detail, and the ability to support day-to-day study operations in compliance with protocol, GCP, and site procedures.</p><p><b>Responsibilities</b></p><ul><li>Coordinate daily clinical trial activities from screening through follow-up.</li><li>Review protocols and support study startup, recruitment, prescreening, and scheduling.</li><li>Obtain and document informed consent as delegated and permitted.</li><li>Maintain accurate source documentation and study records.</li><li>Enter and resolve data in EDC systems.</li><li>Coordinate subject visits, labs, ECGs, vitals, questionnaires, IP accountability support, and study-specific procedures.</li><li>Communicate with participants, caregivers, sponsors, CROs, monitors, vendors, and investigators.</li><li>Prepare for monitoring visits and assist with query resolution.</li><li>Track recruitment, enrollment, visit windows, deviations, and study action items.</li><li>Ensure study activities follow GCP, protocol requirements, and site SOPs.</li></ul><p><b>Requirements</b></p><ul><li>Minimum 3 years of experience as a Clinical Research Coordinator or similar clinical research role.</li><li>Fluent bilingual communication skills in English and Spanish, spoken and written.</li><li>Experience with sponsor/CRO monitoring visits, EDC systems, source documentation, and regulatory binders.</li><li>Strong knowledge of GCP and clinical trial conduct.</li><li>Excellent organization, follow-up, and time-management skills.</li><li>Comfortable communicating with patients and study participants.</li><li>Ability to work on-site and manage multiple studies/tasks.</li><li>Proficiency with Microsoft Office or Google Workspace.</li></ul><p><b>Preferred Qualifications</b></p><ul><li>Experience in CNS, psychiatry, neurology, metabolic, nephrology, or outpatient studies.</li><li>Phlebotomy, ECG, vitals, lab processing, or IATA training.</li><li>CCRC certification or other clinical research certification.</li><li>Experience with recruitment and prescreening workflows.</li></ul><p><b>Compensation</b></p><p>Depending on experience.</p><p><b>Schedule</b><br/>Monday to Friday, [8am to 5 pm]. Occasional flexibility may be required based on study visits.</p><p><b>How to Apply</b><br/>Please submit your resume through Indeed. Qualified candidates may be contacted for a phone screening and interview.</p><p>Pay: Up to $72,000.00 per year</p><p>Work Location: In person</p>

Houston Methodist

<div>At Houston Methodist, the Research Coordinator position is responsible for coordinating the day-to-day activities of research protocols as well as assessing and determining qualification of patients for research studies. This position ensures accurate data collection, documentation, organization and safety of research participants.
<div><b>FLSA STATUS</b><br>
Exempt<br>
<br>
<b>QUALIFICATIONS</b><br>
<br>
<b>EDUCATION</b><ul><li>
Bachelor&rsquo;s degree
</li></ul><br>
<b>EXPERIENCE</b><ul><li>
Two years&rsquo; research experience
</li></ul><br>
<b>SKILLS AND ABILITIES</b><ul><li>
Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
</li><li>Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
</li><li>Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
</li><li>Sufficient in clinical and research data entry
</li><li>Capable of handling challenging/difficult situations
</li>Demonstrates sound judgment and executes analytical skills<br>
<li>
</li></ul><br>
<br>
<b>ESSENTIAL FUNCTIONS</b><br>
<br>
<b>PEOPLE ESSENTIAL FUNCTIONS</b><ul><li>
Under the direction of higher level staff, conducts screening and interviews to evaluate patient eligibility in study.
</li><li>Promotes a positive work environment and contributes to a dynamic, team focused work unit that actively helps one other to achieve optimal department results. Collaborates with all members of the patient care team by actively communicating and reporting pertinent information as it relates to assigned system(s) in a comprehensive manner.
</li><li>Provides contributions towards improvement of department scores for employee engagement.
</li></ul><br>
<b>SERVICE ESSENTIAL FUNCTIONS</b><ul><li>
Responds promptly and accurately to customer complaints, inquiries, and requests for information and coordinate appropriate follow-up calls and/or appointments.
</li><li>Schedules research subject appointments for tests and procedures, such as laboratory tests, x-rays, and other studies specific for the research protocol.
</li><li>Compiles patient information, process, document and enter accurate information in Source Documents, Case Report Forms, Electronic Data Capture portals and Clinical Trial Management System following established procedures.
</li></ul><br>
<b>QUALITY/SAFETY ESSENTIAL FUNCTIONS</b><ul><li>
Maintains records for clinical study and regulatory documents.
</li><li>Under the direction of Research Nurse/Clinical Trial Manager/Physician, captures and reports Adverse Events (A/E) or Serious Adverse Events (SAE) to necessary regulatory authorities.
</li><li>Assists management with research records and regulatory maintenance.
</li></ul><br>
<b>FINANCE ESSENTIAL FUNCTIONS</b><ul><li>
Uses resources efficiently; does not waste supplies. Evaluates and reports on inventory levels. Self-motivated to independently manage time effectively and prioritize daily tasks.
</li><li>Maintains inventory of supplies necessary for the study.
</li></ul><br>
<b>GROWTH/INNOVATION ESSENTIAL FUNCTIONS</b><ul><li>
Maintains working knowledge of the research process and in the conduct of IRB approved research protocols. Follows International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines.
</li>Seeks opportunities to expand learning beyond baseline competencies with a focus on continual development. Completes and updates My Development plan on an on-going basis.<br>
<li>
</li></ul><br>
<br>
<b>SUPPLEMENTAL REQUIREMENTS</b><br>
<ul><b>
WORK ATTIRE</b><li><ul><li>
Uniform: No
</li><li>Scrubs: Yes
</li><li>Business professional: No
</li><li>Other (department approved): Yes
</li></ul></li><br>
<b>ON-CALL*</b><br>
<li><ul><li><i>Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below.</i></li></ul></li><li><ul><li>
On Call* No
</li></ul></li><br>
<b>TRAVEL**</b><br>
<i>**Travel specifications may vary by department**</i><li><ul><li>
May require travel within the Houston Metropolitan area No
</li><li>May require travel outside Houston Metropolitan area No
</li></ul></li></ul></div><b>QUALIFICATIONS</b><br>
<br>
<b>EDUCATION</b><ul><li>
Bachelor&rsquo;s degree
</li></ul><br>
<b>EXPERIENCE</b>
Two years&rsquo; research experience<br>
<ul><li>
</li></ul><br>
<p><b>Company Profile:</b></p><p>
Houston Methodist Academic Institute oversees the Education Institute and Research Institute. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&amp;M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports clinical research protocols and extramurally funded translational research programs.</p><p>
Houston Methodist is an Equal Opportunity Employer.</p></div>

Research Coordinator I - Baytown

East River Medical Imaging

<div><p>Reports To: Senior Director, Strategic Initiatives</p>
<p><b>Summary</b></p>
<p>At East River Medical Imaging, P.C., our mission is to consistently provide the highest quality and availability of diagnostic imaging and therapy with compassion and comfort for our patients. Our physicians are leaders in subspecialized radiology and are committed to advancing patient care through innovative imaging, theranostics, and clinical research.</p>
<p>The <b>Theranostics &amp; Research Coordinator</b> plays a vital role in supporting both the growing Theranostics Program and the clinical research portfolio at East River Medical Imaging. This position is responsible for coordinating patient care, scheduling research and therapeutic procedures, supporting study start-up activities, managing clinical trial data transfers, maintaining regulatory and study documentation, and serving as a liaison between patients, research sponsors, study sites, and clinical staff.</p>
<p>The Coordinator serves as a primary operational contact for the Pluvicto&reg; therapy program and assists in ensuring an exceptional patient experience throughout the treatment journey. The role also supports East River-sponsored and investigator-initiated research studies through participant coordination, documentation management, informed consent support, and adherence to Good Clinical Practice (GCP), institutional policies, and protocol requirements.</p>
<p>This position requires exceptional attention to detail, strong organizational and communication skills, the ability to work independently, and a passion for advancing patient care through clinical research and precision medicine.</p>
<p></p><p><b>Essential Duties &amp; Responsibilities</b></p>
<p><b><i>Theranostics Program Coordination</i></b></p>
<ul><li>Serve as a primary coordinator for the Theranostics Program, including Pluvicto&reg; therapy and future radiopharmaceutical therapies.</li>
<li>Coordinate patient scheduling across consultations, imaging appointments, dosimetry studies, laboratory testing, treatment administration, and follow-up visits.</li>
<li>Monitor patient readiness for treatment by coordinating required bloodwork, insurance approvals, and physician documentation.</li>
<li>Coordinate radiopharmaceutical dose ordering and scheduling with vendors and internal clinical teams.</li>
<li>Communicate appointment details, preparation instructions, and treatment expectations to patients and caregivers.</li>
<li>Act as a patient advocate by addressing questions, facilitating communication, and supporting a best-in-class patient experience.</li>
<li>Collaborate closely with physicians, nurses, technologists, and administrative staff to ensure efficient treatment workflows.</li>
<li>Track patient milestones and ensure timely completion of protocol-required procedures and assessments.</li>
<li>Escalate clinical, scheduling, or operational concerns to appropriate team members.</li>
</ul>
<p><b><i>Clinical Research Operations</i></b></p>
<ul><li>Support study start-up activities, including feasibility assessments, site qualification activities, investigator documentation, training records, and study activation processes.</li>
<li>Coordinate research imaging appointments and protocol-specific procedures.</li>
<li>Maintain study calendars, visit schedules, and participant tracking logs.</li>
<li>Facilitate communication with sponsors, CROs, research coordinators, and participating research sites.</li>
<li>Support participant recruitment, scheduling, and retention activities.</li>
<li>Assist with informed consent discussions and documentation in accordance with applicable regulations and delegated responsibilities.</li>
<li>Coordinate protocol-related communications between Principal Investigators, radiologists, research staff, technologists, and nursing personnel.</li>
<li>Ensure accurate and timely completion of study documentation.</li>
</ul>
<p><b><i>Data Management &amp; Imaging Transfers</i></b></p>
<ul><li>Perform protocol-specific image and data transfers in accordance with study requirements.</li>
<li>De-identify and anonymize imaging data prior to transfer in compliance with HIPAA, sponsor requirements, and study protocols.</li>
<li>Upload imaging studies and supporting documentation to sponsor portals, imaging core labs, and research databases.</li>
<li>Maintain transfer logs and documentation demonstrating data integrity and regulatory compliance.</li>
<li>Troubleshoot data transfer issues and coordinate resolution with sponsors, CROs, core laboratories, and internal IT resources.</li>
<li>Ensure adherence to study timelines and sponsor requirements for imaging submissions.</li>
</ul>
<p><b><i>Regulatory &amp; Quality Support</i></b></p>
<ul><li>Support maintenance of regulatory binders, study files, delegation logs, training documentation, and essential research records.</li>
<li>Assist with internal audits, sponsor monitoring visits, and regulatory inspections.</li>
<li>Review study procedures, policies, and protocol amendments to support operational compliance.</li>
<li>Ensure compliance with Good Clinical Practice (GCP), HIPAA, institutional policies, and applicable regulatory requirements.</li>
<li>Participate in quality improvement initiatives related to research and theranostics operations.</li>
</ul>
<p></p><p><b>Competencies</b></p>
<p><b><i>Attention to Detail</i></b></p>
<p>Demonstrates exceptional accuracy in scheduling, documentation, data management, regulatory compliance, and patient coordination activities.</p>
<p><b><i>Communication</i></b></p>
<p>Communicates effectively and professionally with patients, research sponsors, investigators, research sites, physicians, nurses, technologists, and administrative staff.</p>
<p><b><i>Organization &amp; Time Management</i></b></p>
<p>Successfully manages multiple priorities, deadlines, protocols, and patient schedules in a fast-paced environment.</p>
<p><b><i>Patient-Centered Service</i></b></p>
<p>Demonstrates compassion, empathy, professionalism, and commitment to delivering an exceptional patient experience.</p>
<p><b><i>Problem Solving</i></b></p>
<p>Identifies issues proactively, gathers relevant information, develops solutions, and follows through to resolution.</p>
<p><b><i>Adaptability</i></b></p>
<p>Responds effectively to changing priorities, protocol amendments, evolving workflows, and new technologies.</p>
<p><b><i>Collaboration</i></b></p>
<p>Builds strong working relationships across multidisciplinary teams and contributes to shared organizational goals.</p>
<p></p><p><b>Qualifications</b></p>
<p>To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.</p>
<p><b>Education &amp; Experience</b></p>
<p><b><i>Required</i></b></p>
<ul><li>Bachelor's degree in a health sciences, clinical research, healthcare administration, nursing, public health, or related field.</li>
<li>Minimum of 5 years of healthcare experience, clinical operations experience, or healthcare administration experience.</li>
<li>Experience working with patients in a clinical or healthcare setting.</li>
<li>Strong understanding of medical terminology.</li>
<li>Excellent verbal and written communication skills.</li>
<li>Proficiency in Microsoft Office applications.</li>
</ul>
<p><b><i>Preferred</i></b></p>
<ul><li>Prior experience in radiology, clinical research, research coordination, oncology, nuclear medicine, or therapeutic services.</li>
<li>Knowledge of human subjects research regulations and clinical trial operations.</li>
<li>Experience supporting investigational studies, radiopharmaceuticals, or oncology patient populations.</li>
<li>Experience with clinical trial management systems, research databases, imaging core laboratory submissions, or sponsor portals.</li>
<li>Bilingual skills strongly preferred.</li>
<li>Good Clinical Practice (GCP) training and certification.</li>
</ul>
<p><b><i>Training Requirement</i></b></p>
<ul><li>GCP certification preferred upon hire.</li>
<li>If not already certified, successful completion of Good Clinical Practice (GCP) training is required within the first three months of employment.</li>
</ul>
<p></p><p><b>Skills</b></p>
<ul><li>Exceptional organizational and project coordination skills.</li>
<li>Strong independent work ethic and ability to manage responsibilities with minimal supervision.</li>
<li>Excellent attention to detail and documentation accuracy.</li>
<li>Ability to communicate professionally with patients, physicians, sponsors, research sites, nurses, and technologists.</li>
<li>Ability to maintain confidentiality and handle sensitive health information.</li>
<li>Strong analytical, problem-solving, and critical-thinking skills.</li>
<li>Ability to manage competing priorities while maintaining quality and compliance.</li>
<li>Commitment to continuous learning and professional development.</li>
</ul>
<p></p><p><b>Computer Skills</b></p>
<p>To perform this job successfully, an individual should have experience with:</p>
<ul><li>Microsoft Outlook, Word, Excel, and Teams</li>
<li>RIS/PACS systems</li>
<li>Electronic medical record systems</li>
<li>Research sponsor portals and imaging transfer platforms</li>
<li>Clinical trial databases and tracking tools</li>
<li>Secure file transfer and data management systems</li>
</ul>
<p></p><p><b>Work Environment</b></p>
<p>The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities to perform the essential functions.</p>
<p>This position works primarily in a healthcare and research environment and may occasionally enter patient care and imaging areas. The employee may be exposed to moving mechanical equipment, medical devices, and controlled clinical environments. The noise level is generally moderate.</p>
<p></p><p><b>Physical Demands</b></p>
<p>While performing the duties of this position, the employee is regularly required to communicate, use a computer, walk, stand, reach, and perform administrative and coordination tasks. Occasional lifting of materials up to 25 pounds may be required.</p>
<p>Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.</p>
<p></p><p>The above description is intended to outline the general nature and level of work performed by individuals assigned to this position and is not intended to be an exhaustive list of responsibilities, duties, or qualifications. East River Medical Imaging reserves the right to modify job responsibilities and assignments as business needs evolve.</p></div>

Theranostics & Research Coordinator

Brown University Health

<div><ul><li>Job ID: JR-112254
</li><li>Entity: Rhode Island Hospital
</li><li>Location Name: Rhode Island Hospital
</li><li>City, State: Providence, RI
</li><li>Work Type: FULL TIME
</li><li>Hours Per Week: 40
</li><li>Shift: Day
</li><li>Posted Date: 7/30/2026
</li></ul><div><h2 class="jobSectionHeader"><b>SUMMARY</b></h2>
<p>
The Sr. Research Regulatory Coordinator is responsible for clinical studies through the regulatory portion of the trial submission process to maintaining the regulatory integrity of assigned clinical trials from approval to closure. The Sr. Research Regulatory Coordinator performs multiple tasks in order to meet compliance requirements in research. This position will be overseeing clinical research regulatory requirements for the department. The Sr. Research Regulatory Coordinator will provide support in managing the clinical trials within the department, instructs and advises other staff in regulatory/compliance issues and collaborates with investigators to resolve all regulatory inquiries. The Sr. Research Regulatory Coordinator shall work closely with department leadership.</p>
<p>
Brown University Health employees are expected to successfully role model the organization&rsquo;s values of <b>Compassion</b>, <b>Accountability</b>, <b>Respect</b>, and <b>Excellence</b> as these values guide our everyday actions with patients, customers and one another.</p>
<p>
In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include:</p>
<ul>
<li>Instill Trust and Value Differences</li>
<li>Patient and Community Focus and Collaborate</li>
</ul><h2 class="jobSectionHeader"><b>RESPONSIBILITIES</b></h2>
<p>
The Sr. Research Regulatory Coordinator is responsible for all duties listed under the Regulatory Coordinator position, such as:</p>
<ul>
<li>Develops protocols with the Principle Investigator and provides recommendations on research plan</li>
<li>Coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) including communicating with ancillary committees, study team, business office, contract research organizations, and sponsors</li>
<li>Prepare and maintain study specific regulatory binder(s) and documents</li>
<li>Serves as the regulatory subject matter expert through all phases of a clinical study, including regulatory documents and/or processes related to clinical trials conduct</li>
<li>Initiates and leads special projects, to include process improvement and regulatory training</li>
<li>Ensures proper regulatory compliance in accordance with sponsoring agency requirements</li>
<li>Liaises with sponsors, investigators and team members, providing trial information and updates as required in written, oral and meeting format, adhering to appropriate timelines</li>
</ul>
<p>Additionally, the Sr. Research Regulatory Coordinator position will be responsible for the following:</p>
<ul>
<li>Coordinates and facilitates the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications. Manages the preparation of annual reports to the FDA, as necessary. Manages and updates clinical trial/study information located on the clinicaltrials.gov website, as needed</li>
<li>Ensuring the collection and maintenance of credentialing information for study personnel. Such include conflict of interest forms (COI), CV&rsquo;s, MLs, HSP and GCP training</li>
<li>Coordinate audits and site visits with monitors concerning compliance of regulatory documents. Responsible for preparing for institutional, federal, and sponsor audits and assist with the drafting of audit responses</li>
<li>Assist with training of all regulatory affairs personnel with regards to regulatory compliance. Act as a mentor for new employees and find ways to improve the department&rsquo;s mentorship program</li>
<li>Work directly with department leadership to examine opportunities for regulatory innovation and promote the use of novel approaches within the project team to resolve issues and problems</li>
<li>Compile regulatory-related metrics for use by department leadership</li>
<li>Performs other duties as assigned</li>
</ul><h2 class="jobSectionHeader"><b>MINIMUM QUALIFICATIONS</b></h2>
<h3 class="jobSectionHeader"><b>BASIC KNOWLEDGE</b></h3>
<ul><li>Bachelor&rsquo;s degree in health-related or scientific field is required; Master&rsquo;s degree preferred</li>
<li>SoCRA (Society of Clinical Research Associates) certified or eligible within 18 months of hire</li>
<li>Sound knowledge of all federal, local and state guidelines pertaining to Clinical Research</li>
<li>Must be an independent person, who is capable of making sound judgment pertaining to regulatory issues and have the ability to work independently within the scope of the job requirements. Must demonstrate strong leadership and organizational skills</li>
</ul>
<p>Must possess the following skills:</p>
<ul>
<li><p>Detail-oriented and excellent organizational skills</p>
</li>
<li><p>Strong self-starter</p>
</li>
<li><p>Interpersonal skills</p>
</li>
<li><p>Strong problem-solving skills</p>
</li>
<li><p>Team-oriented</p>
</li>
<li><p>Excellent oral and written communication skills</p>
</li>
<li><p>Proficient in Microsoft Office and in various database applications</p>
</li>
<li><p>Comprehensive knowledge of FDA guidelines</p>
</li>
<li><p>Ability to foster smooth communications and teamwork among clinical research faculty, fellows and staff as well as external organizations necessary</p>
</li>
</ul><h3 class="jobSectionHeader"><b>EXPERIENCE</b></h3>
<ul><li>3-5 years in direct clinical trial administration experience or relevant clinical development and regulatory experience</li>
<li>Past experience in federal, state and/or local programmatic regulations compliance</li>
</ul><h2 class="jobSectionHeader"><b>WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS</b></h2>
<p>
This position is a sedentary position. One must be able to transport paperwork to another building (sometimes up to 10 lbs.) at one time. Bending and stooping may also be requirements for filing of paperwork. Standing to copy may also be required.</p>
<h2 class="jobSectionHeader"><b>
INDEPENDENT ACTION</b></h2>
<p>
This position requires a quick-thinker, who can independently make basic and sometimes complex decisions pertaining to the completion and transmission of required regulatory documentation to internal departments as well as external agencies, including, but not limited to study sponsors, local and federal agencies. The candidate should be able to answer protocol regulatory inquiries from researchers and physicians, as well as from the local Institutional Review Board. This person should also be able to work with outside monitors and work independently. He/she should be able to answer inquiries related to regulatory issues, and if not known, communicate with the correct person to determine the answer.</p>
<h2 class="jobSectionHeader"><b>
SUPERVISORY RESPONSIBILITY</b></h2>
<p>
One to three regulatory staff members.</p>
<h2 class="jobSectionHeader"><b>
Pay Range</b></h2>
<p>
$64,480.00-$106,412.80</p>
<h2 class="jobSectionHeader"><b>
Location</b></h2>
<p>
Rhode Island Hospital - 593 Eddy Street Providence, Rhode Island 02903</p>
<h2 class="jobSectionHeader"><b>
Work Type</b></h2>
<p>
M-F 8am-4:30pm</p>
<h2 class="jobSectionHeader"><b>
Work Shift</b></h2>
<p>
Day</p>
<h2 class="jobSectionHeader"><b>
Daily Hours</b></h2>
<p>
8 hours</p>
<h2 class="jobSectionHeader"><b>
Driving Required</b></h2>
<p>
Yes</p>
<p><i>
Brown University Health is committed to providing equal employment opportunities and maintaining a work environment free from all forms of unlawful discrimination and harassment.</i></p></div></div>

Sr Research Regulatory Coordinator 1

K2 Medical Research

<div>
 This is an
 <strong>
  evergreen requisition
 </strong>
 , meaning we don't have an immediate opening, but we're actively seeking talented professionals for upcoming opportunities. By applying, your information will be reviewed and considered for future roles as they become available. If you're interested in a future with K2 Medical Research, we encourage you to apply!
 <br/>
 <br/>
 At
 <strong>
  K2 Medical Research
 </strong>
 , we are transforming healthcare by delivering tomorrow&rsquo;s treatments today. As a rapidly growing clinical research organization across Florida, Tennessee, and Rhode Island, we lead multiphasic trials in therapeutic areas ranging from neurodegenerative to cardiometabolic medicine. Our culture is grounded in clinical excellence and a patient-first mission. We are seeking mission-driven individuals ready to play a meaningful role in bringing life-changing treatments to the patients who need them most.
 <br/>
 <br/>
 <strong>
  K2
 </strong>
 is pooling for experienced
 <strong>
  Psychometric Raters
 </strong>
 and
 <strong>
  C
 </strong>
 <strong>
  linical Research Coordinator/Project Managers,
 </strong>
 to potentially support our clinic out of
 <strong>
  Winter Garden
 </strong>
 <strong>
  , FL
 </strong>
 .
 <br/>
 <br/>
 These positions will support clinical trial performance and ensure conduct is congruent to the philosophy and mission of K2 Medical Research. Promote good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of federal regulations and K2 Medical Research guidelines (SOPs) for the enrollment and maintenance of subjects in clinical trials, and by collecting, recording, and maintaining source and sponsor documentation.
 <br/>
 <br/>
 <strong>
  Positions And Responsibilities/Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   The Psychometric Rater is responsible for administering and interpreting quantitative and qualitative tests as part of a clinical team investigating treatments for disease states including Alzheimer&rsquo;s, Mild Cognitive Impairment, Depression, and Parkinson&rsquo;s. This position ensures data collection is in congruence with company philosophy and specific scale administration guidelines. Key responsibilities include conducting diagnostic assessments and caregiver interviews, preventing rater drift, and supervising study lead duties for at least four studies. The ideal candidate will demonstrate situational awareness and empathy when working with patients of diminished mental capacity. A minimum of a BS/BA in Psychology is required (Master&rsquo;s preferred), along with at least 2 years of psychometric or clinical research experience. Being a Certified Psychometrist and bilingual (English/Spanish) is strongly preferred.
  </li>
  <li>
   The Clinical Research Coordinator/Project Manager takes a lead role in the end-to-end execution of clinical trials, ensuring strict adherence to study protocols, GCP, and FDA guidelines. This role is responsible for the comprehensive management of assigned studies&mdash;from attending investigator meetings and coordinating with the Principal Investigator to managing complex communications with CROs, Sponsors, and monitors. Key duties include performing clinical tasks such as phlebotomy and ECGs, administering psychiatric rating scales, maintaining interrater reliability, and managing study medication and source documentation. The ideal candidate possesses a Bachelor&rsquo;s degree, strong medical or research experience, and the leadership skills necessary to mentor staff and drive organizational momentum. Bilingual proficiency in Spanish and English is highly desired. Master's level degree highly preferred.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Your growth and well-being are our priority.
 </strong>
 Our comprehensive benefits package for full-time employees includes medical, dental, and vision options, supplemental insurance plans, 401(k) with immediate employer match, generous paid time off, and paid holidays. Most notably, we support a healthy work-life balance through a four-day work week, consisting of 10-hour shifts from Monday through Thursday. Fridays are reserved only for critical business needs or administrative tasks; otherwise, they are your chance to kick-start your weekend.
 <br/>
 <br/>
 <strong>
  Join the K2 Family: Where Compassion and Connection Lead the Way!
 </strong>
 At K2 Medical Research, people come first and we're seeking warm, wonderful humans who effortlessly click with everyone, from our incredible patients to brilliant physicians and dedicated research staff.
 <br/>
 <br/>
 We are an equal opportunity employer. We celebrate what makes you uniquely you and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital, or veteran statuses.
 <br/>
 <br/>
 We value the differences among our team members and are committed to providing reasonable accommodations for qualified individuals with disabilities. If you require a reasonable accommodation to participate in the job application or interview process, please contact Talent@k2med.com. We are here to ensure you have the support and tools you need to shine.
</div>


Winter Garden Clinic Positions (Future Openings • Connect Early)

City of Hope

<div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><b>Associate Clinical Research Coordinator</b></div><div>
Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope&rsquo;s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.</div><div>
Reporting to the Supervisor of Clinical Research Division at City of Hope Duarte Medical Center, we offer multiple full-time on-site positions within the Clinical Trial Office (CTO). As an Associate Clinical Research Coordinator (ACRC), you'll play a pivotal role in ensuring the integrity of research studies. From data abstraction and completion of case report forms to facilitating sponsor visits and maintaining audit-ready data, your responsibilities encompass meticulous coordination. You'll oversee the readiness of laboratory kits and patient-specific equipment for visits, ensuring strict compliance with research protocols. Your duties extend to coordinating biospecimen collection, transportation, and shipment while collaborating with Biospecimen Coordinators to maintain meticulous records. With a focus on maintaining updated patient data in the clinical research management system, your contribution will be integral to the success of diverse research endeavors at City of Hope.</div><div><b>
As a successful candidate, you will:</b></div><ul><li>
Work under the supervision of the Manager, Study Investigators, and Senior Manager, with a focus on protocol-specific duties required by research protocols.</li><li>
Ensure adherence to protocol for specimen collection and sponsor-specific equipment procedures, guaranteeing accurate documentation.</li><li>
Identify and promptly communicate important protocol and data management issues to the supervisor.</li><li>
Uphold Good Clinical Practices, FDA Rules, NIH guidelines, HIPAA regulations, ICH guidelines, and institutional policies for clinical trials.</li><li>
Enter accurate and up-to-date data into the clinical research management system (CRMS) for study patients.</li><li>
Collaborate within the clinical research team, maintaining positive and effective communication while seeking ways to improve job performance and surroundings.</li></ul></div></div></div><div><div><div>
Qualifications - External</div></div></div></div></div></div><div><div><div>
Qualifications - External</div></div></div></div></div></div><div><div><div>
Qualifications - External</div></div></div></div></div></div><div><div><div>
Qualifications - External</div></div></div></div></div></div><div><div><div>
Qualifications - External</div></div></div></div></div></div><div><div><div>
Qualifications - External</div></div></div></div><div><p><b>
Your qualifications should include:</b></p><ul><li>
Bachelor&rsquo;s degree. Experience may substitute for minimum education requirements. (Associate Degree plus minimum of 2 years of experience).</li><li>
At least one year of experience related to the management and conduct of oncology clinical trials in an academic setting, or six months experience as a Project Coordinator or Biospecimen Coordinator in the CTO.</li><li>
Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.</li><li>
Good Clinical Practice (GCP) and Health Information Portability and Accountability ACT (HIPAA)-to be provided by COH if not already completed.</li></ul><p><b>
City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.</b></p><p><b>
City of Hope is an equal opportunity employer.</b></p><p><b>
To learn more about our Comprehensive Benefits, please</b><b> </b><b>CLICK HERE</b><b>.</b></p></div></div>

Assoc Clinical Research Coord

Search 4848+ Clinical trial coordinator jobs near you this August. New roles added regularly across leading industries. Apply today.

4848 clinical trial coordinator jobs Near Me

Clinical Research Coordinator

Clinical Research Coordinator

Research Coordinator I - Baytown

Theranostics & Research Coordinator

Sr Research Regulatory Coordinator 1

Winter Garden Clinic Positions (Future Openings • Connect Early)

Assoc Clinical Research Coord