medical assistant

clinical research assistant, prn Jobs in Miami

clinical research assistant, prn

clinical research assistant, prn (bilingual, registered nurse) Jobs in Miami

clinical research coord - psych (full time, days) Jobs in Miami

clinical research coordinator Jobs in Miami

clinical research coordinator

mci research assistant protocol support laboratory

Baptist Health South Florida

<p></p><div><p>Baptist Health is the region&rsquo;s largest not-for-profit healthcare organization, with 12 hospitals, over 28,000 employees, 4,500 physicians and 200 outpatient centers, urgent care facilities and physician practices across Miami-Dade, Monroe, Broward and Palm Beach counties. With internationally renowned centers of excellence in cancer, cardiovascular care, orthopedics and sports medicine, and neurosciences, Baptist Health is supported by philanthropy and driven by its faith-based mission of medical excellence. For 25 years, we&rsquo;ve been named one of Fortune&rsquo;s 100 Best Companies to Work For, and in the 2024-2025 U.S. News &amp; World Report Best Hospital Rankings, Baptist Health was the most awarded healthcare system in South Florida, earning 45 high-performing honors.</p><p>
What truly sets us apart is our people. At Baptist Health, we create personal connections with our colleagues that go beyond the workplace, and we form meaningful relationships with patients and their families that extend beyond delivering care. Many of us have walked in our patients&rsquo; shoes ourselves and that shared experience fuels out commitment to compassion and quality. Our culture is rooted in purpose, and every team member plays a part in making a positive impact &ndash; because when it comes to caring for people, we&rsquo;re all in.</p><h2 class="jobSectionHeader"><b>
Description:</b></h2><br>
The role involves assisting with the daily operations of clinical studies. Responsibilities may include managing research databases by collecting and organizing patient data entry into several platforms, creating data collection tools, preparing study materials, ensuring quality control of data during entry into various Clinical Trial Management Systems (CTMS), and requesting tissue samples for research protocols when applicable. The position also entails supporting research team members with administrative functions for clinical studies as assigned. Estimated pay range for this position is $21.24 - $25.70 / hour depending on experience.<h2 class="jobSectionHeader"><b>
Qualifications:</b></h2><br>
Degrees:
<ul><li>Associates.</li></ul>
Licenses &amp; Certifications:
<ul><li>Collab Inst Training Init.</li><li>
Basic Life Support.</li></ul>
Additional Qualifications:
<ul><li>Associates degree required.</li><li>
CITI-Collab Inst Training Init certification within 6 months of hire or job entry date.</li><li>
Medical terminology experience preferred.</li><li>
Advanced computer literacy in Microsoft Office.</li><li>
Must be able to work in a high-demand environment with the ability to take responsibility in meeting deadlines.</li><li>
Strong verbal and written communication skills.</li><li>
Phlebotomy certificate preferred.</li><li>
IATA laboratory packaging and shipping certification required within 6 months of job entry for Research Assistants who work in the laboratory.</li></ul>
Minimum Required Experience: 1 Year<p><br>
EOE, including disability/vets</p></div>

MCI Research Assistant, Protocol Support Laboratory

Integrity Clinical Research

<p><b>Job Overview</b></p><p>We are seeking a dependable and detail-oriented Clinical Research Phlebotomist to join our growing clinical research team.</p><p>This position will begin with a primary focus on phlebotomy and laboratory procedures for approximately 90 days due to maternity coverage. After successful completion of this period, the role will transition into a Clinical Research Coordinator (CRC) position with expanded responsibilities.</p><p>This is a long-term opportunity for candidates interested in building a career in clinical research.</p><p><b>Responsibilities</b></p><p>Phase 1: Phlebotomy &amp; Lab Operations (First 90 Days)</p><ul><li>Perform venipuncture and timed PK blood draws</li><li>Process, centrifuge, aliquot, and prepare specimens per protocol</li><li>Maintain accurate and timely documentation</li><li>Ensure compliance with lab manuals and protocol requirements</li><li>Monitor specimen storage and shipping requirements</li><li>Assist with patient intake and vital signs</li></ul><p>Phase 2: Clinical Research Coordinator Duties</p><ul><li>Coordinate study visits and patient scheduling</li><li>Conduct informed consent process</li><li>Document and report adverse events (AE/SAE)</li><li>Maintain regulatory binders and source documentation</li><li>Communicate with sponsors and monitors</li><li>Ensure strict adherence to study protocols and timelines</li></ul><p><b>Required Skills &amp; Qualifications</b></p><ul><li>Minimum 1 year phlebotomy experience</li><li>Comfortable performing multiple blood draws daily</li><li>Strong attention to detail and documentation accuracy</li><li>Ability to follow strict protocol timelines</li><li>Professional communication skills</li><li>Ability to work in a fast-paced clinical environment</li></ul><p>Preferred:</p><ul><li>Clinical research experience</li><li>Medical Assistant certification</li><li>GCP training</li><li>Bilingual (English/Spanish)</li></ul><p><b>Who This Role Is Ideal For</b></p><ul><li>Medical Assistants looking to grow into research</li><li>Entry-level CRCs seeking hands-on experience</li><li>Foreign Medical Graduates seeking U.S. research experience</li><li>Candidates interested in long-term clinical research careers</li></ul><p>Pay: $18.00 - $19.00 per hour</p><p>Work Location: In person</p>

Clinical Research Phlebotomist (Growth to CRC)

IQVIA

<div><div><div>Miami, United States of America | Part time | Office-based | R1531906</div></div><p></p><div><div><h3 class="jobSectionHeader"><b><br>
Site Research Assistant - Miami, FL</b></h3><div><b>
Work Set‑Up:</b> On‑site<br>
<b>Scheduled Weekly Hours:</b> 24 hours per week</div><h2 class="jobSectionHeader"><b>
About IQVIA</b></h2><div>
IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services dedicated to driving healthcare forward. We partner with leading pharmaceutical, biotechnology, and medical device companies to improve patient outcomes and accelerate innovation. Our teams combine deep scientific expertise with cutting‑edge technology to deliver high‑quality data and insights that shape the future of clinical trials.</div><h2 class="jobSectionHeader"><b>
Job Profile Summary</b></h2><div>
The Research Assistant plays a key role in supporting the conduct of clinical trial activities in accordance with all applicable regulations. Success in this role requires logical thinking, strong prioritization skills, adaptability in a fast‑paced environment, and excellent interpersonal and team‑building abilities.</div><h2 class="jobSectionHeader"><b>
Responsibilities</b></h2><ul><li>
Perform EDC data entry and query resolution.</li><li>
Develop strong working relationships and maintain effective communication with study team members.</li><li>
Collaborate with investigators and office staff to build trust and support clinical&ndash;research workflows.</li><li>
Assist with screening, pre‑screening referrals, recruiting, and enrolling research subjects.</li><li>
Manage patient/research participant scheduling and visit coordination.</li><li>
Collect participant history and coordinate follow‑up care and laboratory procedures.</li><li>
Adhere to IRB‑approved protocols and assist in the informed consent process.</li><li>
Promote participant safety and comply with protocol‑related requirements.</li><li>
Coordinate protocol‑related procedures, study visits, and follow‑up care.</li><li>
Comply with company and sponsor SOPs, guidelines, and regulatory expectations.</li><li>
Schedule subject visits and required protocol‑related procedures.</li></ul><h2 class="jobSectionHeader"><b>
Qualifications</b></h2><ul><li>
Minimum of an associate&rsquo;s degree or equivalent education and experience.</li><li>
At least 1 year of experience in a clinical research setting (preferred).</li><li>
Working knowledge of clinical trials and the principles of Good Clinical Practice (GCP).</li><li>
Understanding of protocols, study‑specific procedures, consent forms, and study schedules.</li><li>
Skill in required clinical procedures and familiarity with medical terminology.</li><li>
Strong attention to detail and organizational ability.</li><li>
Ability to establish and maintain effective working relationships with coworkers, managers, physicians, patients, and clients.</li><li>
Applicable certifications and licenses as required by company, state, country, or regulatory bodies.</li><li><b>
Must be able/comfortable doing community outreach, pre‑screening/recruitment, and EDC entry.</b></li><li><b>
Ability to support additional administrative tasks as needed.</b></li></ul><div><b><i>
Please note: This position is not eligible for sponsorship.</i></b></div></div><div><br>
#LI-CES and #LI-DNP #LI-HCP #ONSITE</div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div>
The potential base pay range for this role is $25.00-$39.00 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.</div></div><div></div>

Site Research Assistant - Miami, FL

Evolution Research Group

<div><p><b>About Company:</b></p><p><b>
Who is ERG?</b></p><p>
ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.</p><p><b>
About the Role:</b></p><p>
We are seeking a highly skilled and experienced PRN Paramedic to join our team at CPMI in Miami, FL. The Paramedic assists with the conduct of clinical trials through dispensing investigational drugs, the collection of biological samples, performing venipuncture, electrocardiograms, tube labeling, sample processing, documenting in subject charts, and other related tasks in accordance with the doctor&rsquo;s written orders. In executing these responsibilities, the Paramedic is guided by Good Clinical Practices (GCP).</p><p><b>
Responsibilities:</b></p><ul><li>
Dispense and collect investigational products, routine medications, and PRN medications while subjects are housed on the site observation unit as dictated by written orders.</li><li>
Perform appropriate research protocol procedures which may include but are not limited to vital signs, blood collection and processing, ECGs, and point of care laboratory tests.</li><li>
Perform basic lab procedures including but not limited to preparation of specimen tubes and labels, blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-ups.</li><li>
Ensure that biological specimens are disposed of appropriately.</li><li>
Maintain a clean, safe work environment.</li><li>
Study, learn and comply with ERG site standard operating procedures, and other policies, practices, and regulations where applicable.</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>
Minimum Qualifications:</b></p><ul><li>
Current certification as a Paramedic in the applicable state</li><li>
Minimum 1 year of clinical experience</li><li>
CPR certification</li><li>
Knowledgeable in medical terminology to communicate with physician office and staff.</li><li>
Excellent communication and interpersonal skills</li></ul><p><b>
Preferred Qualifications:</b></p><ul><li>
Uses safety/universal precautions to protect self, subjects and staff.</li><li>
Able to appropriately implement protocol and regulatory requirements in study conduct.</li><li>
Proficient in venipuncture, centrifugation, sample storage and performing electrocardiogram.</li><li>
Excellent documentation practices</li></ul><p><b>
Benefits Overview:</b></p><p>
Our comprehensive benefits package includes:</p><ul><li>
Health insurance</li><li>
Dental &amp; Vision Insurance</li><li>
Matching 401k Retirement Plan</li><li>
Paid Time Off (PTO)</li></ul></div>

PRN Paramedic

Nicklaus Children's Health System

<div><h2 class="jobSectionHeader"><div><b>Description</b></div></h2><p><b>
Job Summary</b></p>
<p>
The Clinical Research Nurse, CTO is part of a central team of specialized research professionals within the Nicklaus Children's Hospital Research Institute (NCH-RI). This research position reports directly to the NCH-RI Clinical Trials Office (CTO) Manager but works closely with Lead CRA's, Study Team (PI, Sub-I's, CRC', etc.), NCH-RI departments and Nicklaus Children's Hospital (NCH) department administrators, and other clinical research professionals to help ensure that clinical research and related activities are performed in accordance with all applicable Federal regulations, NCH/NCH-RI applicable policies and sponsor policies/requirements. This research position will also coordinate team activities to ensure studies are carried out according to protocol, standard operating procedures (SOPs) and applicable guidelines and regulations.</p>
<p><b>
Job Specific Duties</b></p>
<ul>
<li>Coordinates team activities to ensure studies are carried out according to protocol, standard operating procedures (SOPs) applicable guidelines and regulations, and within budget.<br>
</li>
<li>Plans logistical activity for procedures as per protocol and ensures thorough resource planning. Identifies risks on study and ensures that actions are implemented to mitigate risks identified.<br>
</li>
<li>Ensures study specific training materials, documents, and records are prepared and delivered or coordinate training, dry runs, simulations and tests as required.<br>
</li>
<li>Implements, monitors, and assesses the need for training programs to maintain staff skill proficiency, including annual validation and currency of required certifications and licenses.<br>
</li>
<li>Provides protocol-specific training to research study team and NCH hospital/department staff directly involved with the care/treatment of research patients.<br>
</li>
<li>Works with NCH-RI staff to assist with developing, updating and implementing new Research Standard Operating Procedures, guidance documents, standard work and work flows (related to early phase research).<br>
</li>
<li>Coordinates, plans, implements, and evaluates nursing care to clinical trial study participants including but not limited to Adverse Event reporting and other support activities.<br>
</li>
<li>Provides nursing-related care to clinical trial study participants as outlined (and applicable) in the study protocol.<br>
</li>
<li>Coordinates and executes the collection, compilation, and analysis of clinical research data from studies conducted by PIs and study teams at Nicklaus Children&rsquo;s and the NCH-RI.<br>
</li>
<li>Interacts with patients and families to recruit study subjects and ensures compliance with protocol guidelines and requirements of regulatory agencies.<br>
</li>
<li>Attends and participates in investigator meetings, pre-study visits/initiation or coordinator meetings. Produces quality documentation, including completion of assessments within the specified time.<br>
</li>
<li>Coordinates and responsible for the collection of blood samples (PK samples and other), cultures, tissues and other specimens as required by protocol.<br>
</li>
<li>Prepares oral presentations/written reports/data requests describing progress, trends and appropriate recommendations or conclusions as it relates to research at Nicklaus.
<br>
</li><li>Communicates with the Sponsor or representatives regarding scheduling and facilitation of study monitor visits and facilitates communication between PI and Sponsor or Sponsor&rsquo;s Representatives.<br>
</li>
<li>Reviews protocol and provides study feasibility input to the NCH-RI Leadership and Study Start-up Team. Works with QI/QA team to ensure quality standards are being met and reports adverse events, protocol deviations.<br>
</li>
<li>Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.<br>
</li>
<li>Assists with the design and implementation of protocols, forms/questionnaires and the preparation of amendments to protocols and/or modifications to study design as appropriate for local, Investigator Initiated studies.</li>
</ul><h2 class="jobSectionHeader"><div><b>Qualifications</b></div></h2>
<p><b>Minimum Job Requirements</b></p>
<ul>
<li>BSN &ndash; Bachelors of Science in Nursing<br>
</li>
<li>RN Licensure within the State of Florida or Multi-State Enhanced Nursing License Compact (eNLC) &ndash; maintain active and in good standing throughout employment<br>
</li>
<li>IATA certification completion required within 3 months of hire date<br>
</li>
<li>American Heart Association ACLS (Advanced Cardiovascular Life Support) certification required within 2 months of hire<br>
</li>
<li>American Heart Association PALS (Pediatric Advanced Life Support) certification completion required within 6 months of hire<br>
</li>
<li>American Heart Association BLS - maintain active and in good standing throughout employment<br>
</li>
<li>2-4 years of professional research or healthcare experience<br>
</li>
<li>1-3 years of Phase 1 clinical research experience</li>
</ul>
<p><b>Knowledge, Skills, and Abilities</b></p>
<ul>
<li>ARNP highly preferred<br>
</li>
<li>Clinical research certification (e.g., CCRC, CCRP, CRA) preferred<br>
</li>
<li>Bilingual in English/Spanish preferred<br>
</li>
<li>Pediatric Nursing experience in an acute care setting preferred<br>
</li>
<li>Experience in neurology, neurosurgery, or oncology preferred<br>
</li>
<li>Experienced with database management tools and/or REDCap preferred<br>
</li>
<li>In-depth knowledge of Phase I clinical trials<br>
</li>
<li>Demonstrated knowledge of clinical research trial design and execution<br>
</li>
<li>Experienced with electronic medical record and clinical trial management software applications<br>
</li>
<li>Strong written and verbal communication skills<br>
</li>
<li>Excellent interpersonal skills<br>
</li>
<li>Excellent problem-solving skills<br>
</li>
<li>Effective organizational and project management skills<br>
</li>
<li>Ability to pay close attention to detail<br>
</li>
<li>Ability to comprehend professional and scientific journals<br>
</li>
<li>Ability to apply principles of logical and scientific thinking to a wide variety of intellectual and practical problems<br>
</li>
<li>Ability to establish and maintain effective working relationships with coworkers, managers and clients<br>
</li>
<li>Proficiency in Microsoft Office including Access, Word, Excel, Outlook, and PowerPoint<br>
</li>
<li>Willing to work off-hours depending on the study requirements</li></ul><br>
<div></div>
<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>

Clinical Research Nurse (Full Time, Days)

<div><h2 class="jobSectionHeader"><div><b>Description</b></div></h2><p><b>
Job Summary</b></p>
<p>
Under direction of the Senior Manager of Clinical Trial Operations, the Clinical Research Coordinator (CRC) CTO manages and conducts the day-to-day activities of a research study. In general, the CRC ensures the study maintains in accordance with the protocol, applicable regulations, and Good Clinical Practice (GCP) and Institutional Review Board (IRB) requirements. Beyond administrative duties, responsibilities of a CRC may include subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, collection and reviewing study data to enter it into the study and site systems, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities.</p>
<p><b>
Job Specific Duties</b></p>
<ul>
<li>Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate.<br>
</li>
<li>Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records, coordinating the collection, and shipments of specimens as required by protocol.<br>
</li>
<li>Communicates study objectives/procedures to relevant hospital units involved with the study including the establishment of good rapport with the Principal Investigator &amp; providing required assistance.<br>
</li>
<li>Communicates with the Sponsor or their representatives, schedules and facilitates study monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor&rsquo;s Representatives.<br>
</li>
<li>Complies with the Research Finance Compliance policies and procedures including reporting requirements to research finance staff.<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>Responsible for speedy and adequate patient enrollment as determined by Research Management and Principal Investigator in all assigned studies.<br>
</li>
<li>Demonstrates and utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol.<br>
</li>
<li>Follows NCRI&rsquo;s Standard Operating Procedures, AAHRPP, HIPAA, and FDA guidelines for clinical research, and keeps updated in those procedures and/or guidelines.<br>
</li>
<li>Enters required data into CTMS in a timely manner, as stablished in department procedures.
<br>
</li><li>Provides new Protocols, Amendments, and study status updates to necessary research staff for digitization/entry into CTMS.<br>
</li>
<li>Keeps electronic patient files and required documents up-to-date within e-regulatory system.</li>
<li>Collaborates with study investigators to pre-screen and recruit patients to available clinical trials.</li>
</ul><h2 class="jobSectionHeader"><div><b>Qualifications</b></div></h2>
<ul><li></li></ul><p><b>
** Position is onsite in Miami **</b></p><p><b>
Minimum Job Requirements</b></p><ul><li>
Bachelor's degree and previous research experience (OR) Associate's degree and 2 years of research experience (OR) 3 years of research experience (OR) 5 years of healthcare experience</li></ul><p><b>
Knowledge, Skills, and Abilities</b></p><ul><li>
Experience in pediatric clinical research in a hospital setting highly preferred.<br>
</li><li>
Experience with relevant hospital equipment for each clinical trial project.<br>
</li><li>
Bilingual in English/Spanish preferred.<br>
</li><li>
Clinical research certification (CCRC, CCRP, CRA) and IATA certification preferred.<br>
</li><li>
Excellent communication skills in working with both children and adults.<br>
</li><li>
Excellent organizational skills, detail-oriented, people-oriented, flexible, and adaptable to change.<br>
</li><li>
Excellent time management skills.<br>
</li><li>
Knowledge of protocols and its process.<br>
</li><li>
Experience with software applications including word processing, scheduling and contact database, email, web browsing, hospital records, other database software and office equipment.<br>
</li><li>
Availability to work adjusted hours to accommodate subject visits.</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>

Clinical Research Coord - Psych (Full Time, Days)

Gastro Health

<div>
 <strong>
  Gastro Health is seeking a Full-Time Clinical Research Coordinator to join our team!
  <br/>
  <br/>
 </strong>
 Gastro Health is a great place to work and advance in your career. You'll find a collaborative team of coworkers and providers, as well as consistent hours.
 <br/>
 <br/>
 <strong>
  This Role Offers
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   A great work/life balance
  </li>
  <li>
   No weekends or evenings &ndash; Monday thru Friday
  </li>
  <li>
   Paid holidays and paid time off
  </li>
  <li>
   Rapidity growing team with opportunities for advancement
  </li>
  <li>
   Competitive compensation
  </li>
  <li>
   Benefits package
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Duties You Will Be Responsible For
  <br/>
  <br/>
 </strong>
 <strong>
  General Administrative
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Coordinates with Principal Investigator, local site, and Central Hub to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures.
  </li>
  <li>
   Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
  </li>
  <li>
   Assists Principal Investigator to assure that all key personnel or persons &lsquo;engaged&rsquo; in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
  </li>
  <li>
   Cooperates with compliance and monitoring efforts related to sponsored program administration and respond to any audit findings and implement approved recommendations.
  </li>
  <li>
   Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Protocol Preparation &amp; Review
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Attends investigator meetings as required or requested by the PI.
  </li>
  <li>
   Collaborates with the Regulatory Specialist to prepare IRB and any other regulatory submission documents as required by the protocol.
  </li>
  <li>
   Prepares other study materials as requested necessary. These study materials include, but are not limited to, the informed consent document, source documents, enrollment logs, and drug/device accountability logs.
  </li>
  <li>
   Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Conduct of Research
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Reviews and comprehends the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
  </li>
  <li>
   Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
  </li>
  <li>
   Develops and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.
  </li>
  <li>
   Conducts or participates in the informed consent process and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
  </li>
  <li>
   Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant&rsquo;s eligibility or exclusion.
  </li>
  <li>
   Registers each participant in CTMS to ensure billing of study procedures to the appropriate funding source.
  </li>
  <li>
   Coordinates participant tests and procedures.
  </li>
  <li>
   Collects data as required by the protocol. Assures timely completion of Source Documents.
  </li>
  <li>
   Maintains study timelines.
  </li>
  <li>
   Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Gastro Health Research Policy on Investigational Drug/Device Accountability.
  </li>
  <li>
   Completes study documentation and maintains study files in accordance with sponsor requirements and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
  </li>
  <li>
   Retains all study records in accordance with sponsor requirements and Gastro Health Research policies and procedures.
  </li>
  <li>
   Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
  </li>
  <li>
   Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Project Closeout
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Assists the Principal Investigator and Regulatory Specialist in submission of accurate and timely closeout documents to applicable federal agencies, and the sponsoring agency in accordance with federal regulations and sponsoring agency policies and procedures.
  </li>
  <li>
   Arranges secure storage of study documents that will be maintained according to Gastro Health Research policy or for the contracted length of time, whichever is longer.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Minimum Requirements
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Clinical research experience preferred
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  <li>
   Previous phlebotomy skills
  </li>
  <li>
   High School Diploma
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  </li>
 </ul>
 Interested in learning more? Click here to learn more about the location.
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 Gastro Health is the one of the largest gastroenterology multi-specialty groups in the United States, with over 130+ locations throughout the country. Our team is composed of the finest gastroenterologists, pediatric gastroenterologists, colorectal surgeons, and allied health professionals. We are always looking for individuals that share our mission to provide outstanding medical care and an exceptional healthcare experience. We offer a comprehensive benefits package to our eligible employees.
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 Gastro Health is proud to be an Equal Opportunity Employer. We do not discriminate based on race, color, gender, disability, protected veteran, military status, religion, age, creed, national origin, gender identity, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.
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 We thank you for your interest in joining our growing Gastro Health team!
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Clinical Research Coordinator

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