lead clinical research coordinator

UT Southwestern Medical Center

Lead Clinical Research Coordinator- Psychiatry Department - Molecular Imaging Division
 WHY UT SOUTHWESTERN?
 With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report , we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!
 
JOB SUMMARY
 UT Southwestern Medical Center’s Molecular Imaging in Psychiatry Program seeks a Lead Clinical Research Coordinator to help build and lead the operational backbone for PET and MRI studies designed to clarify the biology of psychiatric and neurologic disease and accelerate the development of imaging biomarkers to meaningfully improve diagnosis and treatment.
 The Lead CRC will provide primary stewardship of tightly coordinated visits, managing imaging and clinical data, ensuring regulatory compliance, and collaborating with teams in Psychiatry, Radiology, and the Advanced Imaging Research Center. This role may include 1–2 direct reports, offering leadership experience and a clear pathway for continued career growth as the program expands. The role also offers high ownership, direct exposure to advanced imaging operations, and opportunities to contribute to publications, conference abstracts, and other dissemination activities as studies mature. Ideal candidates bring strong communication skills, confidence in complex imaging settings, and a track record of proactive, independent execution. Previous Experience with Molecular Imaging Protocols is highly preferred
 
BENEFITS
 UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
 PPO medical plan, available day one at no cost for full-time employee-only coverage
 100% coverage for preventive healthcare-no copay
 Paid Time Off, available day one
 Retirement Programs through the Teacher Retirement System of Texas (TRS)
 Paid Parental Leave Benefit
 Wellness programs
 Tuition Reimbursement
 Public Service Loan Forgiveness (PSLF) Qualified Employer
 Learn more about these and other UTSW employee benefits!
 
EXPERIENCE AND EDUCATION
 
Required
 Education
 Bachelor's Degree in medical or science related field
 
Experience
 4 years of clinical research experience with Bachelor's Degree
 Prior experience in the UTSW clinical research mentoring program is highly desirable, and participation in the UTSW clinical research mentoring program may count as additional experience.
 May consider additional years of experience or advanced degree in lieu of education or experience, respectively.
 
Preferred
 Experience
 Experience supporting PET or MRI research studies, particularly involving investigational radiotracers or pharmacokinetic modeling. Familiarity with Institutional Review Board (IRB) and FDA Investigational New Drug (IND) regulatory processes.
 Prior exposure with arterial or venous blood sampling in human studies.
 Working knowledge of REDCap or equivalent databases and familiarity with imaging data management systems or NIH Data Archive submissions.
 Previous experience with Molecular Imaging Protocols
 
Licenses and Certifications
 (BLS) BASIC LIFE SUPPORT may be required based on research study protocols or affiliate location requirements.
 (CPRAED) CPR AED may be required based on research study protocols or affiliate location requirements.
 ACRP of SOCRA certification a plus.
 
JOB DUTIES Recruit, screen, consent, and schedule research participants according to IRB-approved protocols. Coordinate complex PET/MR imaging visits and blood sampling procedures in collaboration with chemistry, imaging, and clinical teams. Provide compassionate participant support, including assistance for individuals with cognitive impairment or psychosis, ensuring safety and comfort during all study procedures. Conduct accurate data entry, de-identification, and quality control for imaging and clinical data. Collaborate with imaging physicists to review PET/MR data for completeness and quality assurance. Prepare datasets for upload to the NIH Data Archive and maintain appropriate data documentation. Track and document biospecimen processing, including arterial plasma samples and radiotracer metabolism assays. Maintain regulatory documentation for IRB, FDA (IND), and institutional audits; assist with submissions, renewals, and amendments. Ensure compliance with Good Clinical Practice (GCP), HIPAA, and radiation safety requirements. Serve as liaison between psychiatry investigators, PET/MR technologists, radiochemistry staff, radiology fellows, physicists, and biologists to coordinate scheduling and communication. Contribute to development of standard operating procedures (SOPs) for imaging workflows, data handling, and participant logistics. Assist in training and onboarding future coordinators as the research team expands.
 Maintains required subject documentation for each study protocol.
 Directly interacts with clinical research participants, as required, for the research study (non-clinical and clinical procedures). Interacts via telephone, telehealth or in-person.
 Coordinates regulatory documentation for research studies that includes maintaining information to comply with industry standards, University policies, FDA requirements or other hospital policies.
 Coordinates and schedules procedures as per research study. A non-licensed coordinator may pend study order sets with oversight by PI.
 Screens, recruits, enrolls and follows subjects according to research protocol guidelines (non-clinical and clinical procedures). May also assist with the consent processes.
 Maintains and coordinates data collection information required for each study that may also include developing CRF's (case report form) or data collection tools.
 Assists in developing and implementing research studies, may include writing clinical research protocols.
 Conducts research procedures according to the protocol with proper training and check offs to maintain scope of service.
 May provide supervision to other members of the research team as necessary.
 May perform research billing activities, as needed, based on size of department (including linking patient calendars
 Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
 Assists PI/supervisor with daily activities of the research team and functions as a liaison between clinical research investigators and various organizations/departments and agencies including, but not limited to HRPP, FDA, Sponsored Programs, and affiliated hospitals.
 Coordinates data management and collection for national (larger/more complex) research studies.
 Serves as lead in preparing annual reports for federal, state, and or/or local agencies on assigned studies.
 Prepares protocols for Institutional Review Board (IRB) submission. May also submit amendments and continuing review documents.
 Assists and monitors and/or maintain research study budgets. Assists the PI with the fiscal management of the trial. Ensures that the patient care charges are allocated appropriately for various research studies.
 Provides in-service training to all study team members and communicates to involved groups.
 Reviews research study protocols to ensure feasibility requirements of the study.
 Assists in developing website or other social media for marketing/recruiting based on assigned clinical research study.
 Enters data in the assigned clinical trial management system, electronic medical record and/or other required data entry systems.
 Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
 Performs other duties as assigned.
 SECURITY AND EEO STATEMENT
 
Security
 This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.
 
EEO
 UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.

Lead Clinical Research Coordinator, Psychiatry Molecular Imaging

Advanced Dermatology and Cosmetic Surgery

We are seeking an experienced Clinical Research Coordinator (CRC) Team Lead to join our dynamic research team. This role is pivotal in supporting clinical trials by working closely with the Principal Investigator (PI) and reporting directly to the Clinical Research Administrator. In addition to standard CRC responsibilities, the Team Lead will oversee site operations, provide guidance to coordinators, and assist with administrative duties to ensure compliance and efficiency in clinical research activities.
 
Key Responsibilities
 <ul>
<li>Coordinate with PI, department, and administration to ensure compliance with federal regulations and sponsor policies.</li>
<li>Assist PI with study feasibility assessments and protocol review.</li>
<li>Prepare and maintain study materials, regulatory binders, and source documentation.</li>
<li>Train and supervise CRCs and research assistants; maintain training logs.</li>
<li>Develop and implement recruitment strategies in line with IRB requirements.</li>
<li>Conduct informed consent processes and maintain accurate documentation.</li>
<li>Manage investigational drug/device accountability and study supply inventory.</li>
<li>Track enrollment, maintain timelines, and communicate effectively with sponsors and participants.</li>
<li>Review and approve budget negotiations; attend weekly leadership meetings.</li>
<li>Act as liaison between site coordinators and research leadership team.</li>
</ul>
Qualifications
 <ul>
<li>Education: CRC certification required.</li>
<li>Experience: Minimum 2 years as a Clinical Research Coordinator with site management experience.</li>
<li>Skills:</li>
<li>Strong organizational and problem-solving abilities.</li>
<li>Excellent communication and interpersonal skills.</li>
<li>Ability to interpret protocols and regulatory requirements.</li>
<li>Proficiency in documentation and compliance standards.</li>
</ul>
Additional Requirements
 <ul>
<li>Ability to work in a demanding environment with required occasional weekend work and travel.</li>
<li>Physical ability to perform tasks such as sitting, bending, and lifting up to 25 lbs</li>
</ul>
Benefits (Eligible for Fulltime Employees*)
 Med/Dent/Vision plus ancillary benefits
 Vacation/PTO
 401k
 
NOTE: This job description may not include all duties assigned to the employee and may be updated and modified by Management, without notice, according to operations at any given time.

Clinical Research Coordinator Team Lead - Spartanburg, SC

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>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: $23.00 - $27.00 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

Headlands Research

<div><div>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.</div> 

<h1 class="jobSectionHeader">
Clinical Research Coordinator (CRC)</h1>

 Location: Scottsdale, AZ | Site Name: Headlands Research - Scottsdale | Full-Time | Clinical Research 


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.

We're seeking a Clinical Research Coordinator (CRC) for our clinical research site located in Scottsdale, AZ. 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.

Type: Regular Full-time Employee 
Schedule: Mondays through Fridays, 8:00am - 4:30pm 
Location: Onsite in Scottsdale, AZ (no capabilities for remote or hybrid work) 
Reports to: Site Director 
Benefits: 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.
<h2 class="jobSectionHeader">
 What We Offer</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> 


<h2 class="jobSectionHeader"> Why Join Us?</h2>

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. 


Responsibilities:
<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> 


Requirements:
<ul>
<li>Required: High school diploma or GED</li>
<li>Preferred: Bachelor's Degree</li>
<li>Experience:
<ul><li>Minimum of 1 year of experience as a Clinical Research Coordinator</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>
</ul></li></ul><ul><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> 


 Apply now to become a part of a team that's changing the future of healthcare&mdash;one trial at a time.</div>

EmVenio Research

<div>Clinical Research Coordinator<div>
Put your talents to work at PCM! Whether you work in our Home Care, Clinical Research, Impairments, or Catastrophic Care division, you will support our mission to deliver care and other services that enhance the quality of life of our clients. Be a part of our dynamic client-focused team and make a difference in your career!
As an on-site Clinical Research Coordinator (CRC), you will provide technical and administrative support to your assigned clinical operations team in the field as well as direct patient care of research study participants. You work with a high attention to detail, reviewing documentation, coordinating clinical study project details, and maintaining data systems - all with a sense of urgency aligned with that of our customers. The position will involve the conduct of trial coordinator activities for EmVenio Research' decentralized network. This will include assessing and following trial participants along with other trial protocol-related activities. In this role the CRC is accountable for the regulatory compliance and performance of assigned mobile clinics and clinician teams conducting decentralized trials as well as patient engagement, and screening. Additional focus will be on timely and accurate EDC data entry and query resolution.
QUALIFICATIONS<ul><li>
Bachelor's degree (B. A. / B. S.) from four-year college or university or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities
</li><li>Two (2) years research experience strongly preferred. Phlebotomy and ECGs experience not required, but preferred.
</li><li>ACRP or SOCRA Clinical Research Certification (Preferred), Clinical Research Training Certification (Preferred)
</li><li>Excellent computer skills, proficient in MS Word, Excel, PowerPoint and ability to obtain knowledge and master all clinical trial database systems.
</li><li>Proven ability to successfully coordinate multiple studies adhering to regulatory and institutional guidelines.
</li></ul><ul><li>Proven ability to communicate effectively within an interdisciplinary team to ensure safe, efficient, quality patient care, both in-person and virtually.
</li></ul><ul><li>Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
</li></ul><ul><li>Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency.
</li></ul><ul><li>Flexibility to reprioritize workload to meet changing project timelines.
</li></ul><ul><li>Responsible for adhering to FDA Good Clinical Practices, FDA regulations, EmVenio Research/Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout.
</li></ul><ul><li>Ability to successfully complete EmVenio Research clinical training program.
</li></ul><ul><li>Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
</li></ul><ul><li>Must have strong interpersonal skills to be able to interact with multiple people on many different levels.
</li></ul><ul><li>May be responsible for basic clinical assessments.
</li></ul>ESSENTIAL FUNCTIONS/AREAS OF ACCOUNTABILITY<ul><li>
Complete study tasks as outlined by trial protocol
</li></ul><ul><li>Ensures documentation is accurate according to EmVenio guidelines and protocols is required
</li></ul><ul><li>Achieves EmVenio standards for quality, customer service, productivity and teamwork through participation in Risk and Quality Improvement programs, clinical meetings and other meetings as required
</li></ul><ul><li>Works collaboratively with nurses, physicians, nurse practitioners, physician assistants, clinical research specialists, leaders, family members, key care givers and any ancillary medical personnel as appropriate
</li></ul><ul><li>Communicates with key stakeholders such as the Principal Investigator, clinical trials team and quality department, regulatory
</li></ul><ul><li>Certain assignments may require provider to perform ECGs, draw blood (Phlebotomy), process and ship lab specimen, etc.
</li></ul><ul><li>Consults with the Site Manager and virtual Clinical Research Coordinator to ensure compliance with guidelines
</li></ul><ul><li>Reviews the medical and social history of members
</li></ul><ul><li>Assist in building the community research site network and developing relationships within that community
</li></ul><ul><li>Participates in recruitment of participants to include personally engaging the general public face to face in local across hard-to-reach communities, attending community events, speaking with physicians and people across diverse cultures and backgrounds to support meeting participant enrollment targets
</li></ul><ul><li>Documenting recruiting efforts and outreach progress
</li></ul><ul><li>Facilitates conversations with potential participants through both inbound and outbound calls sometimes serving as their first introduction to research
</li></ul><ul><li>Participates in all mandatory compliance, patient engagement and other training programs, seeks guidance for compliance-related concerns and adheres to all applicable laws, regulations and EmVenio policies and procedures
</li></ul><ul><li>Maintains positive control of all PHI information
</li></ul><ul><li>Participates in required training and education programs
</li></ul><ul><li>Ensures adherence to clinical trial protocols and supports the clinical trials team in ensuring that trials are conducted and comply with all regulatory, state, national and internationally accepted guidelines for Good Clinical Practice (ICH GCP).
</li></ul><ul><li>Ensures timely and accurate data collection and completion of case report forms relevant to clinical trials or research projects.
</li></ul><ul><li>Assists in liaising with monitors of clinical trials and available to monitor and/or audit when required, with full patient documentation available.
</li></ul><ul><li>Assists in educating EmVenio Research staff and participants regarding the designated clinical trial and procedures and relevant investigations associated with the designated clinical trial and to raise the profile of research throughout the EmVenio Research.
</li></ul><ul><li>Any other duties needed to help drive EmVenio's purpose, fulfill our mission, and abide by our core values.
</li></ul>The typical base pay range for this role is USD $54,080 - $74,880 per year.
Individual base pay depends on various factors, in addition to primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience, skills and other market-based factors.
Available Benefits Include<ul><li>
Medical</li><li>
Dental</li><li>
Vision</li><li>
401(k)</li><li>
Company Paid Short Term Disability</li><li>
Flexible Spending Account (FSA)</li><li>
Health Savings Account (HSA)</li><li>
Paid Time Off</li><li>
Voluntary Benefits
</li></ul>Please contact Carson Moreira-Rego at (866) 776-0127 x387 or at Carson.Moreira-Rego@procasemanagement.com today to learn more about our opportunities where you can make a difference in your own career!
Professional Case Management is an Equal Opportunity Employer.</div></div>

M3 Wake Research

<div>
 
 M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.
 
 
 
 
 Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.
 
 
 
 
 Due to our continued growth, we are hiring for a
 
 Clinical Research Coordinator
 
 at
 
 Wake Research,
 
 an M3 company. This position is on-site and located in
 
 Raleigh, NC
 
 .
 
 
 
 
 
 
 Job Description
 
 
 
 
 The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
 
 
 
 
 
 Essential Duties and Responsibilities:
 
 
 
 
 <ul>
 <li>
 Assisting trial Investigator in screening and review of potential study participants eligibility
 </li>
 <li>
 Maintaining case report forms, charts and documentation
 </li>
 <li>
 Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants
 </li>
 <li>
 Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements
 </li>
 <li>
 Collecting and entering data as necessary
 </li>
 <li>
 Assist management with potential new hire selection and shadowing process
 </li>
 <li>
 Assist with study start-up, maintenance, and close-out of studies as needed for those on the team
 </li>
 <li>
 Ability to be flexible with study assignments
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Clinical Research Coordinator with 1-2 years of experience
 </li>
 <li>
 Phlebotomy experience is highly preferred
 </li>
 <li>
 Previous experience as a medical assistant, LPN, or RN
 </li>
 <li>
 Excellent verbal &amp; written communication skills
 </li>
 <li>
 Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking
 </li>
 <li>
 Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines
 </li>
 <li>
 Extensive clinical trial knowledge through education and/or experience
 </li>
 <li>
 Successful completion of GCP Certification and Advanced CRC preferred
 </li>
 <li>
 Detail-oriented
 </li>
 <li>
 Familiarity with the Code of Federal Regulations as they pertain to human subject protection
 </li>
 <li>
 Strong interpersonal skills
 
 
 </li>
 </ul>
 
 Additional Information
 
 
 
 
 
 About M3:
 
 
 
 
 
 M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we&rsquo;ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.
 
 
 
 
 Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.
 
 
 
 
 Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.
 
 
 
 
 
 Benefits:
 
 
 
 
 
 A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:
 
 
 
 <ul>
 <li>
 401(k), 401(k) matching
 </li>
 <li>
 Dental insurance
 </li>
 <li>
 Disability insurance
 </li>
 <li>
 Employee assistance program
 </li>
 <li>
 Flexible spending account
 </li>
 <li>
 Health insurance
 </li>
 <li>
 Life insurance
 </li>
 <li>
 Paid time off
 </li>
 <li>
 Vision insurance
 </li>
 </ul>
 
 *M3 reserves the right to change this job description to meet the business needs of the organization
 
 
 
 
 
 
 
 
 
 
 
</div>

Care Access

<div><div>About Care Access

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.

With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.

To learn more about Care Access, visit www.CareAccess.com.</div><h3 class="jobSectionHeader">
How This Role Makes A Difference</h3>
<div>The Travel Clinical Research Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinical research process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access to the community, Sponsors, CROs, and study participants and their family members.
</div>
<div></div><div>The Travel Clinical Research Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations.
</div><h3 class="jobSectionHeader">How You'll Make An Impact</h3>
<div><ul><li>Study Preparation:
<ul><li>Ability to understand and follow institutional SOPs
</li><li>Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.
</li><li>Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct
</li><li>Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff
</li><li>Assist with planning and creation of appropriate recruitment and marketing materials
</li><li>Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc.</li>
<li>Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies
</li><li>Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives
</li><li>Assist in the creation or review of protocol specific source documents
</li><li>Determine facility, equipment and outsource vendor requirements and availability
</li><li>Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance</li>
<li>Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks
</li></ul></li><li>Study Management:
<ul><li>Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety.</li>
<li>Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies
</li><li>Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records
</li><li>Collect and evaluate concomitant medications
</li><li>Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual.</li>
<li>Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings
</li><li>Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave
</li><li>Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
</li><li>Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access team in an ongoing fashion
</li><li>Maintain effective relationships with study participants and other Care Access personnel
</li><li>Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access personnel and management
</li><li>Strong and clear communication skills, both verbally and in writing
</li><li>Accept accountability for actions and function independently
</li></ul></li><li>Patient Coordination:
<ul><li>Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment
</li><li>Obtain informed consent per Care Access SOP and document process when revised ICF discussed with patient during course of the trial
</li><li>Administer delegated study questionnaires, where appropriate.
</li><li>Collect and evaluate medical records with the support of medically qualified members of the study team.</li>
<li>Complete visit procedures and ensure proper specimen collection, processing and shipment in accordance with protocol
</li><li>Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
</li><li>Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion
</li><li>Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs)</li>
<li>Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol
</li><li>Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround
</li><li>Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance.
</li><li>Monitor patient progress on study medication
</li></ul></li><li>Documentation:
<ul><li>Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP
</li><li>Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion.
</li><li>Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart
</li><li>Accurately transcribe data to CRF or EDC.
</li><li>Resolve data management queries and correct source data as needed
</li><li>Record protocol exemptions and deviations as appropriate with sponsor.
</li><li>Complete Note(s)-to-File for patient chart and regulatory filing if necessary
</li><li>Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing
</li><li>Maintain copies of patient-specific correspondence in source charts
</li><li>Assist regulatory personnel with completion of continuing/final review reports
</li></ul></li><li>Perform other duties as assigned.
</li></ul></div><h3 class="jobSectionHeader">The Expertise Required</h3>
<div><ul><li>Bilingual proficiency required: Must be fluent in both English and Spanish, with the ability to effectively communicate (written and verbal) in both languages.</li>
<li>Excellent working knowledge of clinical trials, medicine and research terminology
</li><li>Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+
</li><li>Ability to communicate and work effectively with a diverse team of professionals
</li><li>Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
</li><li>Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel.</li>
<li>Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc.</li>
<li>Critical thinker and problem solver
</li><li>Friendly, outgoing personality; maintain a positive attitude under pressure
</li><li>High level of self-motivation and energy
</li><li>Excellent professional writing and communication skills
</li><li>Ability to work independently in a fast-paced environment with minimal supervision
</li></ul>Certifications/Licenses, Education, and Experience:
<ul>
<li>BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred
</li><li>RN or LPN preferred
</li><li>Research Professional Certification- CRCC or exam eligibility preferred
</li><li>A minimum of 3 to 4 years Clinical Research experience
</li><li>A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred.
</li></ul></div><h3 class="jobSectionHeader">How We Work Together</h3>
<ul><li>Travel: Extensive travel required. Candidates must be willing to travel 75% of the time nationwide.
<ul><li>Duties may require travel for a two-week stretch, followed by one week home.
</li><li>Frequency and length of travel may depend on the length and location of study.</li>
<li>Must possess a valid driver's license and be able to operate rental vehicles provided for work-related travel.</li>
</ul>
</li></ul><div>The expected salary range for this role is $70,000 - $100,000 USD per year for full time team members.
<h3 class="jobSectionHeader">
Benefits &amp; Perks (US Full Time Employees)</h3>
<ul><li>Paid Time Off (PTO) and Company Paid Holidays</li>
<li>100% Employer paid medical, dental, and vision insurance plan options</li>
<li>Health Savings Account and Flexible Spending Accounts</li>
<li>Bi-weekly HSA employer contribution</li>
<li>Company paid Short-Term Disability and Long-Term Disability</li>
<li>401(k) Retirement Plan, with Company Match</li>
</ul>
</div><div>Diversity &amp; Inclusion

We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.

If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com

Mandatory Employer Disclosures: 
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction. 
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment. 
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment. 
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29&ndash;38 of Title 28 of the Rhode Island General Laws. 
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.</div></div>

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