sub investigator

Civia Health

<div>
 
 Job Type:
 
 Full-time, on-site
 
 
 
 Reports to:
 
 Senior Manager, Site Management
 
 
 
 Join Us at Civia Health
 
 
 
 We&rsquo;re looking for a compassionate and experienced Nurse Practitioner to support our clinical research team in conducting Phase 2&ndash;4 trials, with a particular focus on metabolic conditions and GLP-1 therapies. If you thrive in a collaborative, patient-centered environment and are passionate about research-driven care, we&rsquo;d love to meet you.
 
 
 At Civia Health, you're not just taking a job: You're joining a mission to transform the way clinical research is done. Our purpose is bold: to bring clinical trials front and center in your community, make them accessible to everyday people, and empower underrepresented communities to participate.
 
 
 We&rsquo;re reinventing how clinical studies are run, delivering valid, scalable evidence with a consumer-first mindset. Too often, trials are expensive, fragmented, and overlook the experience of the participant. At Civia, we&rsquo;re changing that. Our leadership team are experienced industry leading, visionary professionals who know what&rsquo;s broken &mdash; and how to fix it.
 
 
 We treat participants like valued partners, not research subjects. That means supporting their agency, putting their needs, comfort, and enjoyment first &mdash; and rewarding them generously for their time and effort.
 
 
 
 What It Means To Work At Civia
 
 
 
 Every team member plays a crucial role in reshaping clinical research. You&rsquo;ll help make studies more human-centered, inclusive, and efficient. We're looking for people who are driven by purpose, inspired by innovation, and ready to roll up their sleeves to do meaningful work.
 
 
 At Civia, your contributions aren&rsquo;t just transactional, they&rsquo;re
 
 
 transformational
 
 
 .
 
 
 
 What You&rsquo;ll Do
 
 
 
 <ul>
 <li>
 Conduct study visits including medical assessments, physical exams, and protocol-specific procedures.
 </li>
 <li>
 Partner with principal investigators and research staff to ensure quality, safety, and regulatory compliance.
 </li>
 <li>
 Engage participants with empathy&mdash;providing clear education, answering questions, and ensuring comfort throughout the trial process.
 </li>
 <li>
 Identify, document, and report adverse events per protocol and regulatory standards.
 </li>
 <li>
 Maintain accurate, timely, and high-quality documentation in source records and EDC systems.
 </li>
 <li>
 Contribute to continuous improvement of workflows and study execution with a team-first mindset.
 </li>
 <li>
 Occasional travel may be required for audits, site visits, or team meetings.
 
 
 </li>
 </ul>
 
 What You Bring
 
 
 
 <ul>
 <li>
 Active, unrestricted Nurse Practitioner license.
 </li>
 <li>
 2+ years of clinical research experience (Phase 2&ndash;4 trials preferred).
 </li>
 <li>
 Experience with GLP-1 therapies or metabolic/endocrine research highly preferred.
 </li>
 <li>
 Strong knowledge of GCP/ICH guidelines; certification is a plus.
 </li>
 <li>
 Excellent clinical judgment, attention to detail, and communication skills.
 </li>
 <li>
 A collaborative spirit and commitment to doing what&rsquo;s best for the patient and the team.
 
 
 </li>
 </ul>
 
 What We Offer
 
 
 
 <ul>
 <li>
 Competitive compensation
 </li>
 <li>
 Medical, dental, and vision insurance
 </li>
 <li>
 Generous PTO and paid holidays
 </li>
 <li>
 Flexible scheduling options
 </li>
 <li>
 Professional development and continuing education support
 </li>
 <li>
 A mission-driven team that values respect, inclusion, and innovation
 
 
 </li>
 </ul>
 
 Ready to Make an Impact?
 
 
 
 <ul>
 <li>
 Mission with Meaning: Be part of a purpose-led team committed to health equity and real-world impact.
 </li>
 <li>
 Startup Energy, Proven Expertise: Work fast, adapt quickly, and help build something new; guided by seasoned visionary professionals who&rsquo;ve seen what needs to change.
 </li>
 <li>
 People First Culture: We care deeply about our patients, participants, and each other. Collaboration, transparency, and bold, straight-talking are core to how we work.
 </li>
 <li>
 Invested in Your Growth: We don&rsquo;t just hire for today; we&rsquo;re building the leaders and changemakers of tomorrow.
 
 
 </li>
 </ul>
 If you&rsquo;re ready to be part of something meaningful&mdash;and work with people who care deeply about doing good work&mdash;apply today by submitting your resume and cover letter to the link above. We&rsquo;re excited to learn more about you!
</div>

Nurse Practitioner/Sub-Investigator

Frontage Laboratories

<div></div><div>Assistant Clinical Research Coordinator
Title: Assistant Clinical Research Coordinator
Location: Secaucus, NJ, onsite
Reports to: Manager of Clinical Operations.
Full-time/ Hourly 
Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
The Assistant Clinical Research Coordinator Assists the Clinical Research Coordinator in developing strategies for implementing study procedures in compliance with the study protocol.
Roles &amp; Responsibilities:<div><ul><li>
Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures.</li><li>
Develops a strategy for implementing study procedures in compliance with the study protocol.</li><li>
Performs study procedures (e.g., obtain ECG recordings, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Clinical Research Coordinator, Principal Investigator, and Sub-Investigators.</li><li>
Records study data in the source documents. Evaluates and reviews study data to ensure accuracy and completeness.</li><li>
Assists the clinic team in transcribing study data from source documents to sponsor designated electronic case report forms.</li><li>
Resolves data queries in conjunction with the sponsor.</li><li>
Assists the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor.</li><li>
Assists with preparation of protocols, informed consents, amendments and other necessary documents for review by the sponsors and IRB.</li><li>
Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator.</li><li>
Maintains investigator/sponsor files in accordance with the FDA and GCP Guidelines.</li><li>
Assists in the screening of research subjects to evaluate their eligibility for a clinical study.</li><li>
Creates and performs QC procedures.</li><li>
Establishes and maintains source documentation for study protocols in conjunction with the Principal Investigator and Sub-Investigators.</li><li>
Other assigned.</li></ul></div><div></div> 
Education, Experience &amp; Skills Required:<div><ul><li>
At least 6 months&rsquo; experience supporting clinical research study conduct.</li></ul></div><ul><li>Must possess a general knowledge of applicable clinical research regulatory requirements; general knowledge of GCP and ICH guidelines is preferred.</li><li>Strong computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint.</li><li>Strong written and verbal communication skills.</li><li>Effective time management and organizational skills.</li><li>Attention to detail and accuracy in work.</li><li>Knowledge of applicable protocol requirements.</li></ul>
Salary: $25.00/hour
Benefits:<ul><li>
401k Employer Match with immediate vesting</li><li>
Vision Insurance</li><li>
Medical and Dental Insurance with multiple coverage options</li><li>
FSA (Medical, Dependent Care, and Commuter)</li><li>
Short Term Disability</li><li>
Long Term Disability</li><li>
Life Insurance</li><li>
Generous Paid Holidays and PTO</li></ul>
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.</div>

Assistant Clinical Research Coordinator/Equipment Supervisor

K2 Medical Research

<div>
 At
 
 K2 Medical Research
 
 , 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.
 
 
 K2 is seeking a
 
 Clinical Research Assistant
 
 to support our clinic out of
 
 Orlando (Maitland)
 
 
 , FL
 
 in our Phase I Healthy Studies Unit.
 
 
 The Clinical Research Assistant will support clinical trial performance and conduct 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.
 
 
 
 Primary Responsibilities
 
 
 
 <ul>
 <li>
 Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator.
 </li>
 <li>
 Assist the Site Director and Project Management team on projects as needed.
 </li>
 <li>
 Adhere strictly to the study protocol; obtain exemptions when necessary/appropriate.
 </li>
 <li>
 Communicate protocol issues to CRO and/or Sponsor, Site Administrator, Director, Principal or Sub-Investigator.
 </li>
 <li>
 Articulate all pertinent issues to the Pl or document by email/letter or during meetings.
 </li>
 <li>
 Collect initial psychiatric and medical information by interviewing patients and by accessing other appropriate sources.
 </li>
 <li>
 Ensure a flow of communication including telephone conferences between patient, study staff, referral sources, Sponsor and/or CRO, Monitor{s), Auditors and any marketing groups hired by the Sponsor.
 </li>
 <li>
 Utilize various psychiatric rating scales and maintaining interrater reliability with other clinicians at K2 Med.
 </li>
 <li>
 Perform clinical tasks including, but not limited to, vital signs, height and weight, ECG, phlebotomy, specimen packaging.
 </li>
 <li>
 Maintain timely K2 Medical Research source documentation as well as sponsor required information.
 </li>
 <li>
 Dispense and maintain accurate records of study medication.
 </li>
 <li>
 Educate patients and family regarding their study and clinical drug trials in general.
 </li>
 <li>
 Complete all monitor and sponsor queries in a timely manner.
 </li>
 <li>
 Provide appropriate community resource referrals to patients, caretakers, and family at conclusion of patient's participation in study.
 
 
 </li>
 </ul>
 
 Knowledge, Skills, And Abilities
 
 
 
 <ul>
 <li>
 Outstanding verbal and written communication skills.
 </li>
 <li>
 Excellent interpersonal and customer services skills.
 </li>
 <li>
 Strong time management and organizational skills In depth knowledge of industry regulations.
 </li>
 <li>
 Proven ability to and foster mentoring relationships.
 </li>
 <li>
 Ability to create momentum and foster organizational change.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 HS Diploma or GED Transcript required. Bachelor's degree strongly preferred.
 </li>
 <li>
 Prior experience in a clinical environment preferred. Experience in clinical research is ideal.
 </li>
 <li>
 LPN, RN, or other medical licensure or certification preferred.
 </li>
 <li>
 Applicants that don't meet 100% of the above qualifications but who have a combination of related education, applicable experience, demonstrated capability, and a genuine passion for success in this position may also be consider.
 
 
 </li>
 </ul>
 
 Your growth and well-being are our priority.
 
 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.
 
 
 
 Join the K2 Family: Where Compassion and Connection Lead the Way!
 
 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.
 
 
 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.
 
 
 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>

Research Assistant

Thomas Jefferson University & Jefferson Health

<div>Job Details
Works under direct supervision and assists research coordinators with organizing, gathering and compiling clinical research data.
 
Tracks and maintains credentialing documentation for staff and all researchers participating in clinical trials in accordance with IRB regulations. May provide clerical and technical support to ensure adherence to research protocols and quality of information received.
Job Description
<ul><li>Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson.
</li><li>Performs a variety of research, data base and clerical duties in support of clinical trials to assist investigators in organizing, gathering and compiling clinical research data.
</li><li>Organizes and maintains documentation required for clinical trial(s).
</li><li>Informs Principal Investigator and/or designated individual on any issues concerning patient&rsquo;s response to treatment/medication/ any adverse effects overall to patients.
</li><li>Assists Principal Investigator with IRB filings and annual reviews.
</li><li>May assist in the enrollment of human subjects. 
</li></ul><div><div>Minimum High School Diploma or equivalent.
</div></div><div><div>AND
</div></div><div><div>Experience in research or clinical setting preferred .
</div></div>Work Shift
Workday Day (United States of America)
Worker Sub Type
Regular
Employee Entity
Albert Einstein Medical Center
Primary Location Address
60 Township Line Road, Elkins Park, Pennsylvania, United States of America
Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University , home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health , nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.
Jefferson is committed to providing equal educational and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status.
Benefits
Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&amp;D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps ), have access to medical (including prescription) insurance.
For more benefits information,</div>

Clinical Research Assistant (Full time) Jefferson Moss-Magee Rehab, Elkins Park

Jefferson Health

<div>
 
 Job Details
 
 
 
 Works under direct supervision and assists research coordinators with organizing, gathering and compiling clinical research data. Tracks and maintains credentialing documentation for staff and all researchers participating in clinical trials in accordance with IRB regulations. May provide clerical and technical support to ensure adherence to research protocols and quality of information received.
 
 
 
 Job Description
 
 
 
 <ul>
 <li>
 Performs a variety of research, data base and clerical duties in support of clinical trials to assist investigators in organizing, gathering and compiling clinical research data.
 </li>
 <li>
 Organizes and maintains documentation required for clinical trial(s).
 </li>
 <li>
 Informs Principal Investigator and/or designated individual on any issues concerning patient&rsquo;s response to treatment/medication/ any adverse effects overall to patients.
 </li>
 <li>
 Assists Principal Investigator with IRB filings and annual reviews.
 </li>
 <li>
 May assist in the enrollment of human subjects.
 
 
 </li>
 </ul>
 Minimum High School Diploma or equivalent.
 
 
 
 AND
 
 
 
 
 Experience
 
 
 
 Experience in research or clinical setting preferred.
 
 
 
 Work Shift
 
 
 
 Rotating (United States of America)
 
 
 
 Worker Sub Type
 
 
 
 Regular
 
 
 
 Employee Entity
 
 
 
 Thomas Jefferson University
 
 
 
 Primary Location Address
 
 
 
 132 S 10th Street, Philadelphia, Pennsylvania, United States of America
 
 
 Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.
 
 
 Jefferson is committed to providing equal educa&shy;tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status.
 
 
 
 Benefits
 
 
 
 Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&amp;D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance.
 
 
 For more benefits information, please click here
</div>

Clinical Research Assistant (Part Time | Pharmacology/Experimental Therapeutics)

University of Miami

<div>Current Employees:
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet .
Clinical Research Coordinator 2
The University of Miami/UHealth department of Neurology has an exciting opportunity for a Full Time Clinical Research Coordinator 2 to work at the UHealth Medical Campus. The Clinical Research Coordinator 2 serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies. This role assists in the day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel.
 
 
CORE JOB FUNCTIONS
<ul><li>Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.
</li><li>Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.
</li><li>Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.
</li><li>Maintains study binders and filings according to protocol requirements, UM and department policy.
</li><li>Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.
</li><li>Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
</li><li>Assists in implementing protocol amendments under direct supervision of the Principal Investigator.
</li><li>Assists with study orientation and protocol related in-services to research team and clinical staff.
</li><li>Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule.
</li><li>Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators&rsquo; academic administrative personnel, and departments.
</li><li>Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.
</li><li>Adheres to cultural competency guidelines; implements strategies to meet study participants&rsquo; needs for language translation, health literacy, etc.
</li><li>Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
</li><li>Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
</li><li>Adheres to University and unit-level policies and procedures and safeguards University assets.
</li></ul>Department Specific Functions 
The Clinical Research Coordinator 2 is a mid-level professional working within the Neurology Stroke Division. This role involves assisting in the planning, coordination, implementation, monitoring, and evaluation of specific clinical research studies. The coordinator supports daily operations related to the execution of clinical research protocols, from initiation to close-out, ensuring compliance with regulatory and sponsor guidelines. Responsibilities include collaborating with study team members, faculty, and other staff or study sites to maintain participant safety and adherence to approved protocols.
Duties covered in this position encompass all aspects of clinical trial coordination, emphasizing regulatory compliance and participant safety. In addition, the Clinical Research Coordinator-2 must work closely with and maintain constant communication with the Study Principal Investigator and Senior Study Coordinators to ensure alignment and seamless execution of research activities.
The coordinator also manages administrative tasks, facilitates information flow, and organizes study activities and personnel.
Duties covered in this position encompass all aspects of clinical trial coordination, emphasizing regulatory compliance and participant safety. 
The Clinical Research Coordinator 2 is responsible for coordinating clinical research trials within the Neurology Stroke Division, including the following functions:
<ul><li>Complete and maintain the institution-required training essential to gain certification in research ethics, compliance, and regulatory standards to conduct human subject studies.
</li><li>Completion of all study-specific trainings and certifications.
</li><li>Screening participants for eligibility.
</li><li>Conducting the informed consent process.
</li><li>Enrolling participants and, as required, performing randomization according to the study protocol.
</li><li>Coordinate the follow up study visits following the protocol.
</li><li>Ensuring regulatory compliance throughout the study. Maintain study files according to protocol requirements, UM guidelines, and department policy.
</li><li>Entering study data into the electronic database in a timely manner.
</li><li>Assisting with investigational medication dispensing from the Research Pharmacy/Investigational Pharmacy.
</li><li>Communicate with the Research Pharmacy/Investigational Pharmacy to ensure the study medication is kept following the study specifications and maintain accurate study drug accountability.
</li><li>Monitors compliance with processing, storing and shipping participant specimens to central research laboratory as per the study protocol.
</li><li>Meeting with study monitors and maintaining all regulatory documents. Flexible hours may be necessary depending on clinic days.
</li><li>The CRC-2 may also collaborate with investigators in other divisions on sponsored research studies.
</li><li>Support multiple stroke research studies by performing various duties.
</li><li>Assist with the startup of new studies.
</li><li>Assist in onboarding and training new study team members.
</li><li>Provide guidance and oversight to junior research coordinators.
</li><li>Perform quality assurance (QA) on study binders in preparation for study monitor visits.
</li><li>Communicate with Research Pharmacy/Investigational Pharmacy to ensure proper management and accountability of study medication
</li><li>Demonstrate the ability to work independently or collaboratively within a team environment.
</li><li>Ability to work independently and/or in a collaborative environment.
</li><li>Ability to work in a fast-paced environment due to the limited time window for enrollment in acute Stroke clinical trials.
</li><li>Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
</li><li>Prepares local and Central IRB submissions including initial submission, continuing reviews, reportable events, and amendments. 
</li></ul> 
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
 
 
CORE QUALIFICATIONS
<ul><li>Bachelor&rsquo;s degree in relevant field required
</li><li>Minimum 2 years of relevant experience required 
</li></ul> 
Knowledge, Skills and Abilities:
<ul><li>Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
</li><li>Teamwork: Ability to work collaboratively with others and contribute to a team environment.
</li><li>Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
</li><li>Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.
</li></ul>The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
Job Status:
Full time
Employee Type:
Staff</div>

Clinical Research Coordinator 2

Cardiovascular Associates of America - CVAUSA

<div>
 
 
 Research Coordinator &ndash; Patient Screening &amp; Enrollment
 
 
 
 
 
 
 Location: On-site in Tucker, Georgia
 
 
 
 
 
 Organization:
 
 Clinical Research Program (Cardiovascular Focus)
 
 
 
 
 Great research starts with the right patients&mdash;and the clinical insight to identify them.
 
 
 
 
 We&rsquo;re seeking a
 
 Research Coordinator &ndash; Patient Screening &amp; Enrollment
 
 who brings both clinical judgment and operational precision to the front end of the clinical trial lifecycle. This role is ideal for someone who can interpret protocols, navigate medical records with confidence, and engage patients thoughtfully&mdash;even when that means initiating outreach.
 
 
 
 
 If you&rsquo;re comfortable combining clinical knowledge, technology, and patient communication to drive enrollment success, this role was built for you.
 
 
 
 
 The Role
 
 
 
 
 As the
 
 Research Coordinator &ndash; Patient Screening &amp; Enrollment
 
 , you will lead patient identification and enrollment coordination for industry-sponsored clinical trials. You&rsquo;ll apply clinical skills to review protocols and medical records, use EMR systems to develop eligibility lists, and communicate directly with patients to support enrollment goals.
 
 
 
 
 You&rsquo;ll work in close partnership with
 
 Principal Investigators (PIs)
 
 , clinical teams, and research leadership to ensure studies enroll efficiently, ethically, and on schedule.
 
 
 
 
 What You&rsquo;ll Do
 
 
 
 Clinical Screening &amp; Eligibility Assessment
 
 <ul>
 <li>
 
 
 Review clinical trial protocols and apply inclusion/exclusion criteria accurately.
 
 
 </li>
 <li>
 
 
 Conduct detailed medical record reviews to assess patient eligibility.
 
 
 </li>
 <li>
 
 
 Collaborate with PIs and sub-investigators to confirm eligibility determinations.
 
 
 </li>
 <li>
 
 
 Maintain precise documentation of screening decisions and eligibility status.
 
 
 </li>
 </ul>
 
 T
 
 echnology &amp; EMR-Based Identification
 
 
 <ul>
 <li>
 
 
 Use the electronic medical record (EMR) to identify potential study participants through chart review, reports, and registries.
 
 
 </li>
 <li>
 
 
 Develop and maintain screening and recruitment lists aligned with protocol criteria.
 
 
 </li>
 <li>
 
 
 Enter and track screening and enrollment activity in CTMS or other tracking systems.
 
 
 </li>
 </ul>
 
 
 Patient Outreach &amp; Engagement
 
 
 <ul>
 <li>
 
 
 Conduct direct patient outreach, including phone calls and follow-up communications, to introduce research opportunities.
 
 
 </li>
 <li>
 
 
 Confidently and professionally cold-call patients identified through EMR screening, using approved scripts and patient-centered communication.
 
 
 </li>
 <li>
 
 
 Educate patients about study participation, next steps, and scheduling expectations.
 
 
 </li>
 </ul>
 
 
 Scheduling &amp; Coordination
 
 
 <ul>
 <li>
 
 
 Schedule screening visits, study visits, and follow-up appointments in coordination with clinic workflows.
 
 
 </li>
 <li>
 
 
 Ensure visit schedules align with protocol requirements and investigator availability.
 
 
 </li>
 </ul>
 
 
 Enrollment Tracking &amp; PI Communication
 
 
 <ul>
 <li>
 
 
 Track enrollment progress against sponsor targets and timelines.
 
 
 </li>
 <li>
 
 
 Provide PIs and site leadership with regular updates on screening pipelines and enrollment performance.
 
 
 </li>
 <li>
 
 
 Identify and escalate barriers to enrollment and collaborate on solutions.
 
 
 </li>
 </ul>
 
 
 What We&rsquo;re Looking For
 
 
 <ul>
 <li>
 
 
 Clinical background or experience (e.g.,
 
 RN, LPN, MA, CRC
 
 , or equivalent clinical research experience).
 
 
 </li>
 <li>
 
 
 Demonstrated ability to read and interpret clinical trial protocols and medical records.
 
 
 </li>
 <li>
 
 
 Strong proficiency with EMR systems and comfort navigating complex patient data.
 
 
 </li>
 <li>
 
 
 Excellent communication skills, including comfort with outbound patient calls and cold outreach.
 
 
 </li>
 <li>
 
 
 Strong organizational and time-management skills with attention to detail.
 
 
 </li>
 <li>
 
 
 Experience with CTMS or research tracking tools (
 
 REALTIME-CTMS a plus
 
 ).
 
 
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 A proactive, patient-focused professional who takes ownership of enrollment outcomes.
 
 
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 Ideal Experience
 
 
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 Prior experience in patient screening, recruitment, or enrollment for clinical trials.
 
 
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 Cardiovascular or specialty clinic experience.
 
 
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 Experience working in a fast-paced clinical environment with multiple protocols.
 
 
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 Comfort balancing clinical judgment with enrollment goals and sponsor expectations.
 
 
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 Why This Role Matters
 
 
 
 
 Enrollment is the engine of clinical research. In this role, your clinical expertise, technical skills, and patient engagement directly determine whether studies succeed&mdash;and whether patients gain access to innovative therapies.
 
 
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Research Coordinator

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