lead clinical research coordinator

Nicklaus Children's Health System

<div><h2 class="jobSectionHeader"><div><b>Description</b></div></h2><p><b>
Job Summary</b></p>
<p>
Under direction of a Research Clinical Trial Operations leader, the Lead Clinical Research Coordinator CTO will independently coordinate and will be accountable for the overall administration and outcome of multiple clinical studies within the Clinical Trials Office, requiring advanced-level knowledge and skills, involving human subjects that are being conducted within the Nicklaus Children's Research Institute. Ensures processes are in place and roles are defined in order for studies to be conducted smoothly and compliantly, avoiding delays or errors with patient registration/enrollment and/or documentation and in accordance with protocol requirements. Responsible for subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, report writing, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities. Provides guidance, training, and mentorship to Clinical Research Coordinators, Research Assistants and/or other support personnel.</p>
<p><b>
Job Specific Duties</b></p>
<ul>
<li>Serves as a subject-matter expert and resource for the research team on the compliant conduct of assigned studies.<br>
</li>
<li>Facilitates communication between investigators and Clinical Research Coordinators on subject-matter or technical matters.<br>
</li>
<li>Oversees study conduct including all support data collection for study start-up activities.<br>
</li>
<li>Oversees collection, maintenance, and reporting of accurate patient data for submissions to sponsors, maintaining patient records, and coordinating the collection and shipments of specimens as required by protocol.<br>
</li>
<li>Reviews and confirms subject study eligibility with PI/Sub-I of assigned studies.<br>
</li>
<li>Oversees study registration, patient screening/enrollment, and overall study requirements.<br>
</li>
<li>Registers and enrolls research participants.<br>
</li>
<li>Aggregates, tracks, trends, and reports research study and patient screening/enrollment data as required.<br>
</li>
<li>Interacts with patients and families to recruit (screen, consent, and enroll) study subjects and ensures compliance with the protocol.<br>
</li>
<li>Complies with the Research Finance Compliance policies and procedures including time and effort reporting for grants.<br>
</li>
<li>Submits protocol amendments and other documents requiring IRB submission to the Research Regulatory Affairs team and notifies CTMS support staff for protocol digitization.<br>
</li>
<li>Enters Research Patient information into CTMS within 72 hours of enrollment, patient visit, or patient-related event.<br>
</li>
<li>Pre-screens potential research participants and enters information into CTMS within real time (if possible) or within 24 hours.<br>
</li>
<li>Compiles accurate CTMS metrics data for updating SAC CTO slides and runs weekly enrollment reports for management review.<br>
</li>
<li>Updates study statuses in CTMS and ensures study enrollment changes are communicated to Research Regulatory Affairs team and CTO Management.<br>
</li>
<li>Attends meetings with Research management, research team, and/or PI/Sub-Is and is prepared to discuss research portfolio and/or patient status.</li>
</ul><h2 class="jobSectionHeader"><div><b>Qualifications</b></div></h2>
<p><b>Minimum Job Requirements</b></p>
<ul>
<li>Bachelor's degree or higher and 5 years of research experience (OR) 9 years of research experience</li>
<li>Clinical research certification through SOCRA or ACRP (CCRC, CCRP, CRA) required within 1 year in position</li><br>
</ul>
<p><b>Knowledge, Skills, and Abilities</b></p>
<ul>
<li>Knowledge of rules and regulations governing the designated research.<br>
</li>
<li>Ability to use logical and scientific thinking to interpret technical data and solve a broad range of problems.<br>
</li>
<li>Bilingual in English/Spanish.<br>
</li>
<li>Excellent communication skills in working with both children and adults.<br>
</li>
<li>Software applications experience including word processing, scheduling and contact database, email, web browsing, hospital records, other database software and office equipment.<br>
</li>
<li>Experience with relevant hospital equipment for each clinical trial project.<br>
</li>
<li>Experience working on clinical trials, interventional studies all phases.
</li><li>Advanced knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).<br>
</li>
<li>Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.<br>
</li>
<li>Ability to train, guide, and mentor peers.<br>
</li>
<li>Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.<br>
</li>
<li>Ability to respond calmly under stressful conditions.<br>
</li>
<li>Ability to maintain confidentiality of sensitive information.<br>
</li>
<li>Ability to effectively work in a team.<br>
</li>
<li>Excellent interpersonal skills.<br>
</li>
<li>Excellent time management skills.</li></ul><br>
<br>
<br>
<h2 class="jobSectionHeader"><div><b>Job:</b></div></h2>
Research<br>
<h2 class="jobSectionHeader"><div><b>
Department:</b></div></h2>
RI - ADMINISTRATION-2100-380950<br>
<h2 class="jobSectionHeader"><div><b>
Job Status:</b></div></h2>
Full Time</div>

Lead Clinical Research Coordinator - Onsite

Key Clinical Research

<p><b>Job Summary</b><br/>We are seeking an experienced Clinical Research Coordinator to join our growing research team. The Clinical Research Coordinator plays a pivotal role in the management and execution of clinical trials. This position involves overseeing the day-to-day operations of research studies, managing all aspects of assigned clinical trials in accordance with Good Clinical Practice (GCP), FDA regulations, IRB policies and internal standard operating procedures (SOP's). This role requires a detail-orientated, organized professional that thrives in a fast- paced environment and has strong interpersonal and problem -solving skills.</p><p><b>Duties</b></p><ul><li>Coordinate and manage all aspects of assigned clinical trials from initiation through close out.</li><li>Ensure adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements.</li><li>Conduct patient recruitment, prescreening, screening, and informed consent processes.</li><li>Serve as the primary liaison between sponsors, CRO's, monitors and internal staff.</li><li>Monitor patient progress throughout the study, documenting any adverse events or changes in condition.</li><li>Collect, record and maintain accurate source documentation and case report forms.</li><li>Prepare for and participate in monitoring visits, audits and inspections</li><li>Maintain comprehensive records of study activities, including medical terminology relevant to the research.</li><li>Collaborate with physicians, nurses, and other healthcare professionals to facilitate effective communication regarding study protocols.</li></ul><p>Qualifications</p><ul><li>Bachelor&rsquo;s degree in a relevant field; nursing experience is a plus.</li><li>Strong understanding of clinical development processes and regulatory requirements.</li><li>Proficient in medical terminology and data collection methodologies.</li><li>Ability to perform blood sampling and phlebotomize patients safely and effectively is a plus.</li><li>Ability to manage multiple studies with minimal supervision from leadership.</li><li>Excellent organizational skills with the ability to supervise staff effectively.</li><li>Strong communication skills to interact with patients, healthcare professionals, and research teams.</li><li>Prior experience in a clinical research setting is highly desirable.</li><li>Certified Clinical Research Coordinator (CCRC) preferred.</li></ul><p>This role is essential for advancing medical knowledge through rigorous research practices while ensuring the safety and well-being of participants involved in clinical trials.</p><p>Job Type: Full-time</p><p>Pay: $21.89 - $28.77 per hour</p><p>Expected hours: 40 per week</p><p>Benefits:</p><ul><li>401(k)</li><li>Health insurance</li><li>Paid time off</li></ul><p>Work Location: In person</p>

Clinical Research Coordinator

The IMA Group

<div><div><div><b>Company Overview</b><br>
The Clinical Research Division at The IMA Group is a dynamic hub of expertise and innovation, committed to advancing healthcare through meaningful clinical trials and studies. Our dedicated team collaborates with industry leaders to conduct patient-focused research across diverse therapeutic areas. Guided by ethical practices and strict regulatory standards, we are driving groundbreaking medical solutions that shape the future of healthcare.</div><div></div><div><b>
Job Summary:</b><br>
</div><div></div><div><b>
IMA Clinical Research</b> is excited to welcome a <b>Clinical Research Coordinator (CRC)</b> with phlebotomy experience to our growing NYC team! In this role, you&rsquo;ll be at the heart of medical discovery, coordinating and managing clinical trials that bring new treatments to patients who need them most. You&rsquo;ll oversee studies in compliance with FDA requirements and GCP guidelines while working closely with investigators, sponsors, and clinical staff.</div><div>
</div><div><b>
Why join us?</b> You&rsquo;ll gain hands-on experience with innovative studies, grow your career in clinical research, and be part of a mission-driven team advancing tomorrow&rsquo;s medicine. The starting salary for this position is $60,000&ndash;$65,000 annually, based on experience.</div><div></div><div><b>
Key Responsibilities</b></div><ul><li><div>
Coordinate and manage clinical trials according to sponsor protocols and SOPs.</div></li><li><div>
Gain and maintain in-depth knowledge of study protocols and procedures.</div></li><li><div>
Serve as a key liaison with sponsors, CROs, monitors, IRBs, labs, and clinical teams.</div></li><li><div>
Support investigators and staff in ensuring successful study execution.</div></li><li><div>
Ensure timely reporting of adverse and serious adverse events per protocol.</div></li><li><div>
Maintain accurate and timely documentation in compliance with ALCOA principles.</div></li></ul><div></div><div><b>
Qualifications &amp; Skills</b></div><ul><li><div>
Minimum <b>2 years of clinical research and phlebotomy experience</b>.</div></li><li><div>
Clinical Research Coordinator certification (CCRC) preferred.</div></li><li><div>
Bachelor&rsquo;s degree required; Master&rsquo;s degree or equivalent experience preferred.</div></li><li><div>
Skilled in managing multiple projects independently.</div></li><li><div>
Strong communication, problem-solving, and leadership abilities.</div></li><li><div>
Clinical healthcare experience (e.g., vitals, diagnostic tests) is a plus.</div></li></ul><div></div><div><b>
What We Offer</b><br>
At IMA, we invest in our people and their futures:</div><ul><li><div><b>
Comprehensive Health Coverage</b>: Medical, Dental, and Vision insurance.</div></li><li><div><b>
Work-Life Balance</b>: Generous PTO, holidays, and floating holiday.</div></li><li><div><b>
Retirement Planning</b>: 401k with employer match.</div></li><li><div><b>
Financial &amp; Educational Support</b>: Tuition reimbursement and student loan repayment assistance (tax-free).</div></li><li><div><b>
Family Benefits</b>: Paid parental and maternity leave.</div></li><li><div><b>
Security &amp; Protection</b>: Company-paid life insurance, ADD, LTD, STD, plus voluntary coverage options.</div></li></ul></div><div></div><div><b><i>
The IMA Group is an Affirmative Action/Equal Opportunity Employer</i></b></div><div>
</div><div>
Our Government Services Division supports local, state, and federal agencies and delivers professional and objective medical and psychological examinations as well as ancillary services. Our Payer Services Division meets the evaluation and screening needs of Carriers, TPAs, Public Entities and Employers and includes behavioral health and physical medicine specialty services, working with a wide range of organizations within the workers' compensation, disability, liability, and auto markets. Our Clinical Research Division performs all types of Phase II-IV clinical trials in multiple therapeutic areas through a flexible nationwide network of site locations and virtual capabilities.</div><div></div><div>
#LI-EG1 #LI-ONSITE</div></div>

Clinical Research Coordinator- Manhattan, NY

University of Arizona

<div></div><div><div><div><div><div><b>Posting Number</b></div> <div>req24272
</div></div><br>
<div><div><b>Department</b></div> <div>Psychiatry
</div></div><br>
<div><div><b>Department Website Link</b></div> <div>https://psychiatry.arizona.edu/</div>
</div><br>
<div><div><b>Location</b></div> <div>University of Arizona Health Sciences
</div></div><br>
<div><div><b>Address</b></div> <div>Tucson, AZ USA
</div></div><br>
<div><div><b>Position Highlights</b></div>
<div><p>This clinical research coordinator position is responsible for coordinating a clinical trial patient through all protocol-required procedures. This includes, but is not limited to, obtaining consent, screening, collecting and entering data, and performing follow-up for all patients enrolled in assigned clinical trials. The coordinator serves as the liaison between regulatory, research, clinic, clinical faculty, and research sponsor staff to carry out the required events outlined in the protocol calendars, including data entry. The coordinator is involved in carrying out the clinical research protocols from the time the project is initiated through study closure. It is expected that this person will have, or develop, a knowledge base of the assigned disease areas and of clinical research coordinator responsibilities in the sleep, circadian, and mental health areas.</p>
<i>
Outstanding U of A benefits include health, dental, and vision insurance plans; life insurance and disability programs; paid vacation, sick leave, and holidays; UA/ASU/NAU tuition reduction for the employee and qualified family members; state retirement plan; access to UA recreation and cultural activities; and more!</i>
<p>The University of Arizona has been recognized for its innovative work-life programs.</p></div><br>
</div><br>
<div><div><b>Duties &amp; Responsibilities</b></div>
<div><ul><li>Administer clinical tests and questionnaires as part of clinical research protocols (assessments of sleep, circadian rhythms, mental health, cognitive functioning).</li><li>
Data entry for clinical study protocols and preparation of reports.</li><li>
Prepare documents for submission to Research Intake and IRB, including protocols and consent forms, working with faculty, residents, external sponsors and internal departments.</li><li>
Assist in research coordination to include administrative support schedule coordination, intake and maintaining records/files.</li><li>
Since some research activities will take place during evenings and/or weekends, a willingness to occasionally work those hours is required.</li><li>
Conduct and review recruitment activities, including community-based recruitment and activities in coordination with Psychiatry clinics.
</li><li>Work closely with participants to assist them through the various protocol elements of the research study.</li><li>
Assist with administrative tasks associated with the program. This includes assistance with all various administrative tasks within the research program with a concentration surrounding purchasing and receipts.</li></ul><p><b>
Knowledge, Skills &amp; Abilities:</b></p><ul><li>
Demonstrated strong interpersonal, communication, and problem-solving skills.</li><li>
Excellent organizational skills.</li><li>
Attention to detail.</li><li>
Ability to multitask using time management skills.</li><li>
Comfortable with navigating electronic databases.</li><li>
Other tasks as assigned.</li></ul><p></p><p><i><br>
This job posting reflects the general nature and level of work expected of the selected candidate(s). It is not intended to be an exhaustive list of all duties and responsibilities. The institution reserves the right to amend or update this description as organizational priorities and institutional needs evolve.</i></p></div><br>
</div><br>
<div><div><b>Minimum Qualifications</b></div>
<ul><li>Bachelor's degree or equivalent advanced learning attained through experience required.</li><li>
Up to 1 year of relevant work experience may be required.</li></ul>
</div><br>
<div><div><b>Preferred Qualifications</b></div><ul>
<li>Experience working or volunteering directly with patients in a healthcare setting, or human subject experience.</li>
<li>Experience working with people with mental health conditions and/or sleep or circadian research.</li>
<li>Comfort in administering sensitive mental health assessments.</li>
<li>CCRC training.</li>
<li>Experience with federal regulation adherence.</li>
</ul>
</div><br>
<div><div><b>FLSA</b></div> <div>Exempt
</div></div><br>
<div><div><b>Full Time/Part Time</b></div> <div>Full Time</div>
</div><br>
<div><div><b>Number of Hours Worked per Week</b></div> <div>40
</div></div><br>
<div><div><b>Job FTE</b></div> <div>1.0
</div></div><br>
<div><div><b>Work Calendar</b></div> <div>Fiscal</div>
</div><br>
<div><div><b>Job Category</b></div> <div>Research</div>
</div><br>
<div><div><b>Benefits Eligible</b></div> <div>Yes - Full Benefits
</div></div><br>
<div><div><b>Rate of Pay</b></div> <div>$47,356.00 - $59,195.00
</div></div><br>
<div><div><b>Compensation Type</b></div> <div>salary at 1.0 full-time equivalency (FTE)
</div></div><br>
<div><div><b>Grade</b></div> <div>6
</div></div><br>
<div><div><b>Compensation Guidance</b></div> <div>The <b>Rate of Pay Field</b> represents the University of Arizona&rsquo;s good faith and reasonable estimate of the range of possible compensation at the time of posting. The University considers several factors when extending an offer, including but not limited to, the role and associated responsibilities, a candidate&rsquo;s work experience, education/training, key skills, and internal equity.
<br>
<br>
The <b>Grade Range</b> represent a full range of career compensation growth over time. The university offers compensation growth opportunities within its career architecture. To learn more about compensation, please review our Applicant Compensation Guide and our Total Rewards Calculator.
</div></div><br>
<div><div><b>Career Stream and Level</b></div> <div>PC1</div>
</div><br>
<div><div><b>Job Family</b></div> <div>Clinical Research
</div></div><br>
<div><div><b>Job Function</b></div> <div>Research
</div></div><br>
<div><div><b>Type of criminal background check required:</b></div> <div>Name-based criminal background check (non-security sensitive)
</div></div><br>
<div><div><b>Number of Vacancies</b></div> <div>1
</div></div><br>
<div><div><b>Target Hire Date</b></div>
</div><br>
<div></div><div><div><b>Expected End Date</b></div>
</div><br>
<div></div><div><div><b>Contact Information for Candidates</b></div> <div>Shivani Mann, shivani@arizona.edu
</div></div><br>
<div><div><b>Open Date</b></div> <div>10/24/2025</div>
</div><br>
<div><div><b>Open Until Filled</b></div> <div>Yes</div>
</div><br>
<div><div><b>Documents Needed to Apply</b></div> <div>Resume and Cover Letter</div>
</div><br>
<div><div><b>Special Instructions to Applicant</b></div>
</div><br>
<div></div><div><div><b>Notice of Availability of the Annual Security and Fire Safety Report</b></div> <div>In compliance with the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act (Clery Act), each year the University of Arizona releases an Annual Security Report (ASR) for each of the University&rsquo;s campuses. These reports disclose information including Clery crime statistics for the previous three calendar years and policies, procedures, and programs the University uses to keep students and employees safe, including how to report crimes or other emergencies and resources for crime victims. As a campus with residential housing facilities, the Main Campus ASR also includes a combined Annual Fire Safety report with information on fire statistics and fire safety systems, policies, and procedures.
<br>
Paper copies of the Reports can be obtained by contacting the University Compliance Office at cleryact@arizona.edu.</div></div></div></div></div>

Clinical Research Coordinator I

Evolution Research Group

<div><p><b>About Company:</b></p><p>
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I&ndash;IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.</p><p><b>
Why join us?</b> We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.</p><p><b>
Job Description:</b></p><p>
The Clinical Research Coordinator II is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC II completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.</p><p><b>
Responsibilities:</b></p><p><b>
General</b></p><ul><li>
Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.</li><li>
Develop draft source documents and review the documents for accuracy and clarity prior to study start up.</li><li>
Develop a mechanism for subject recruitment and ongoing communications with PCP and nursing staff as appropriate.</li><li>
Review with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.</li><li>
Manage studies with sponsor, and Principal Investigator to ensure compliance with protocol requirements.</li><li>
Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.</li><li>
Serve as a mentor and trainer for support staff and new employees once the Clinical Research Coordinator has been approved to do so by the Site Director.</li><li>
Communication of all protocol related issues/problems to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial.</li><li>
Contribute to the SOP review and development as delegated by the Site Director.</li></ul><p><b>
Study Management</b></p><ul><li>
Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.</li><li>
Attend the investigator meeting for each assigned protocol, as appropriate.</li><li>
Completion of IRB study renewals and maintain copies of all IRB communications.</li><li>
In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.</li><li>
Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator</li><li>
Review and obtain informed consent from potential study volunteers.</li><li>
Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations.</li><li>
Maintain organized, accurate and complete study records including but not limited to regulatory documents, signed informed consents, IRB correspondence/approvals, source documentation, drug dispensing logs, subject logs and study-related communications.</li><li>
Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.</li><li>
Ensure timely and accurate CRF completion for each study subject.</li><li>
Perform study close-out procedures.</li><li>
Store study records appropriately</li><li>
Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG&rsquo;s objectives.</li></ul><p><b>
Skills and Qualifications:</b></p><ul><li><b>
Education and experience</b><ul><li>
High School Diploma or its equivalent; College degree preferred.</li><li>
Two (2) to four (4) years of experience OR certification as a Clinical Research Coordinator</li><li>
Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.</li><li>
Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff.</li><li>
Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.</li><li>
Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.</li></ul></li><li><b>
Requirements</b><ul><li>
Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.</li><li>
Excellent communication skills (interpersonal, written, verbal)</li><li>
Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)</li></ul></li></ul></div>

Clinical Research Coordinator-FT CRC

General Dynamics Information Technology

<div><div>Type of Requisition:</div>
Regular<div></div><div>
Clearance Level Must Currently Possess:</div>
None<div></div><div>
Clearance Level Must Be Able to Obtain:</div>
None<div></div><div>
Public Trust/Other Required:</div>
NACLC (T3)<div></div><div>
Job Family:</div>
Science and Research<div></div><div>
Job Qualifications:</div><div>
Skills:</div>
Clinical Research, Human Subjects Research, IRB (Inactive)<div>
Certifications:</div>
None<div>
Experience:</div>
3 + years of related experience<div>
US Citizenship Required:</div>
No<div></div><div>
Job Description:</div><div>
GDIT&rsquo;s Military Health Team is hiring a Clinical Research Coordinator to support research projects for the Traumatic Brain Injury Center of Excellence (TBICoE) located at Naval Medical Center San Diego.</div><div></div><div>
MISSION:</div><div><i>
TBICoE unifies a system of TBI health care, reliably advancing the science for the warfighter and ready to meet future brain health challenges</i></div><div></div><div>
HOW YOU WILL MAKE AN IMPACT:</div><div>
The CRC is responsible for coordinating and assuring integrity of all activities associated with conducting TBICoE clinical investigations in the area of TBI. S/he will ensure compliance with local, state, and/or federal regulatory</div><div>
requirements.</div><ul><li>
Coordinates and assures integrity of all activities associated with conducting TBICoE TBI clinical investigations as it relates to compliance with local, state, and/or federal regulatory requirements.</li><li>
Assists Principal / Associate Investigators in the preparation and submission of clinical protocols, consent forms and other documents to the scientific review committee, IRB and other regulatory organizations.</li><li>
Prepares requests for actions/proposals to include assisting with and providing coordination for grant proposal applications and their associated documentations and requirements as needed. Facilitates the flow and approval processes for relevant projects as needed or requested.</li><li>
Maintains regulatory files related to TBICoE clinical investigations.</li><li>
Communicates with research participants, staff, regulatory affairs and data management groups, laboratory and clinical investigators, management and outside collaborators.</li><li>
Recruits, interviews, and screens TBICoE clinical research study volunteers, administers and obtains informed consent.</li><li>
Assists in the collection and analysis of data to evaluate volunteer eligibility for enrollment.</li><li>
May assist with TBI Program/Quality Improvement initiatives at their site.</li><li>
Assists in the collection, analysis and interpretation of laboratory and clinical data obtained during a medical evaluation, report significant values, findings and events that require prompt attention to clinical investigators.</li><li>
Assists with the documentation and reporting of adverse events, completes and reviews subject eligibility criteria, protocol compliance, omissions, and errors and submits these forms as required.</li><li>
Prepares and maintains written and electronic volunteer databases/logs.</li><li>
Performs data extraction and chart reviews of patients&rsquo; and/or research participant&rsquo;s medical records or other relevant record/systems, as applicable.</li><li>
Ensures that research records are stored and secured properly and that inventory and records are updated and properly maintained.</li><li>
Conducts data verification as indicated, documents, assists the investigator and protocol coordinator with questions, may transcribe and resolve queries of data on study forms (hardcopy and/or electronic).</li><li>
Prepares documents, under direction of project leads. Trains incoming staff on study procedures and SOPs.</li><li>
Assists with statistical analyses and descriptive data capture under direction of project leads. Works with the site senior clinical research director and other senior research leads for the collection, documentation and analysis of metrics to ensure a successful research program.</li><li>
Must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.</li><li>
US citizenship with the ability to pass a T3 security investigation.</li></ul><div></div><div>
WHAT YOU'LL NEED TO SUCEED (REQUIRED):</div><ul><li>
Bachelor's degree or higher in biology, psychology or related science.</li><li>
Must have Human Subjects training completed.</li><li>
3+ years clinical investigations experience.</li><li>
Knowledge of standard qualitative and quantitative data collection techniques.</li><li>
Good writing and analytical skills</li><li>
familiarity with social science research methodology.</li><li>
Ability to work comfortably with computer software, including Microsoft Word, Excel, Outlook and PowerPoint.</li></ul><div></div><div>
WHAT WOULD BE EVEN BETTER (PREFERRED):</div><ul><li>
Master&rsquo;s degree preferred.</li><li>
Certification as a Clinical Research Coordinator (CCRC), Clinical Research Professional (CCRP) and/or Clinical Research Associate (CCRA) preferred (must maintain Continuing Education credit sufficient to maintain certification when applicable).</li><li>
Previous experience supporting the Traumatic Brain Injury Center of Excellence.</li><li>
Previous experience with transcranial direct current stimulation.</li><li>
Previous experience with EEG.</li><li>
TBI research experience.</li><li>
Prior experience within the DoD/VA systems of care preferred.</li></ul><div></div><div>
SKILLS &amp; ATTTIBUTES FOR SUCESS:</div><ul><li>
Excellent communication skills, excellent organizational skills, basic clinical acumen, knowledge of universal precautions, organizational skills and proficiency in research conduct.</li><li>
Ability to follow general instructions, work in a team environment.</li></ul><div></div><div>
ENVIRONMENTAL DETAILS:</div><ul><li>
Must be able to sit and stand for long periods of time.</li><li>
May encounter patients who are confused, agitated, or abusive.</li><li>
Office and clinical environment.</li></ul><div></div><div>
#GDITFedHealthJobs</div><div>
#MilitaryHealthGDITJobs</div><div>
#GDITClinicalResearchJobs</div><div>
#GDITHealth</div><div>
#gditpriority</div><div></div>
The likely salary range for this position is $69,264 - $92,000. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.<div></div><div>
Scheduled Weekly Hours:</div>
40<div></div><div>
Travel Required:</div>
None<div></div><div>
Telecommuting Options:</div>
Onsite<div></div><div>
Work Location:</div>
USA CA San Diego<div></div><div>
Additional Work Locations:</div><div></div><div>
Total Rewards at GDIT:</div>
Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.<div></div>
We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.<div></div>
Join our Talent Community to stay up to date on our career opportunities and events at<div><div>
gdit.com/tc</div>.</div><div></div>
Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans</div>

Clinical Research Coordinator (Traumatic Brain Injury Research)

Centricity Research

<div><p><b>Clinical Research Coordinator I (CRC I)</b></p><p><b>
Join Us at Centricity Research!</b></p><p>
Centricity Research is one of the largest clinical research networks in North America. We are a fully centralized Integrated Research Organization (IRO) specializing in conducting Phase I-IV clinical trials in over 35 therapeutic areas: inpatient and outpatient; pharmaceutical, biotechnology, and medical device trials.<br>
</p><br>
<p><b>About the Role</b></p><p>
We&rsquo;re looking for a Clinical Research Coordinator I (CRC I) to support the successful execution of clinical studies by managing a mix of administrative and clinical tasks. In this role, you&rsquo;ll work closely with Investigators to ensure study activities are organized, compliant, and aligned with protocol requirements. The CRC I brings strong attention to detail and a solid grasp of study protocols, helping keep research operations running smoothly, accurately, and on time.</p><p><b><br>
What You&rsquo;ll Do</b></p><p><b>
Study Coordination &amp; Participant Safety</b></p><ul><li>
Ensure the safety and well-being of all study participants</li><li>
Conduct study visits in line with protocol, GCP, and internal SOPs</li><li>
Collect study-specific assessments (e.g., vitals, ECGs) and maintain documentation accuracy</li><li>
Obtain and maintain proper informed consent</li></ul><p><b>
Recruitment, Screening &amp; Enrollment</b></p><ul><li>
Promote and support recruitment initiatives to identify eligible study participants</li><li>
Screen participants according to protocol inclusion/exclusion criteria</li><li>
Guide participants through the consent process and ensure proper documentation</li><li>
Schedule and coordinate study visits across the full lifecycle of participation</li></ul><p><b>
Study Execution &amp; Data Collection</b></p><ul><li>
Perform clinical tasks such as phlebotomy, sample processing/shipping, point-of-care testing, and participant monitoring</li><li>
Accurately complete source documentation, CRFs, queries, and maintain CTMS records</li><li>
Dispense and track investigational products according to protocol</li><li>
Collect and report adverse events, including timely SAE reporting</li><li>
Participate in site feasibility questionnaires (FQs) and pre-study visits (PSVs) to support site readiness and study start-up activities</li></ul><p><b>
Quality, Compliance &amp; Site Support</b></p><ul><li>
Prepare for monitoring visits, audits, and maintain regulatory files</li><li>
Perform regular quality control checks on source data and documents</li><li>
Support lab supply inventory, equipment maintenance, and administrative needs</li><li>
Assist with community engagement and outreach events as needed</li></ul><p>
</p><p><b>You Might Be a Great Fit If You:</b></p><ul><li>
Have a bachelor&rsquo;s degree in a health, science, or research-related field (or equivalent combination of education and experience)</li><li>
Have 2&ndash;4 years of experience in a healthcare setting and are comfortable with clinical tools like blood pressure monitors, ECG machines, and weight scales (nice to have, but not required)</li><li>
Have phlebotomy experience &mdash; or are open to learning it where permitted by law (we&rsquo;ll provide the training).Understand basic medical terminology, or are eager to learn it quickly</li><li>
Are passionate about contributing to clinical trials that impact global health</li><li>
Are organized, detail-oriented, and skilled at multitasking in a fast-paced environment</li><li>
Are proactive, collaborative, and take ownership of your work</li><li>
Value open communication and thrive in a team-driven environment</li></ul><p>
</p><p><b>Why Centricity Research?</b></p><p><b>
Our Mission</b></p><p>
We connect people to scientific advancements through groundbreaking research within a deeply human experience.</p><p><b><br>
Our Core Values</b></p><ul><li><b>
Quality</b>: We aim for excellence and integrity in everything we do - because lives depend on it.</li><li><b>
Care</b>: We show up for each other, our customers, and our mission - always going the extra mile.</li><li><b>
Be the Change You Seek</b>: We're adaptable, forward-thinking, and constantly improving - for the betterment of all.</li><li><b>
One Team</b>: We collaborate, support one another, and succeed together.</li><li><b>
Grow for Good</b>: We grow with purpose - to expand access to research and improve global health.</li><li><b>
Own It</b>: We take initiative, deliver results, and follow through - with passion and accountability.</li></ul><p>
</p><p><b>Benefits</b></p><ul><li>
Comprehensive health, dental, and vision insurance</li><li>
Enhanced EAP &ndash; mental health support</li><li>
Flexible PTO + paid holidays</li><li>
Continuing education reimbursement</li><li>
401(k) / RRSP with company match and immediate vesting</li></ul><p>
</p><p><b>Ready to Apply?</b></p><p>
We&rsquo;d love to hear from you &ndash; apply now!</p><p>
We&rsquo;re an equal opportunity employer committed to building a diverse and inclusive workplace. We welcome applicants from all backgrounds and will provide accommodations during the hiring process upon request.</p></div><p></p>

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