clinical research coordinator (crc)-ft

clinical research coordinator 1 Jobs in Miami

clinical research coordinator 1

clinical research coordinator 2 Jobs in Miami

clinical research coordinator 2

clinical research manager (crm) - spanish speaker Jobs in Miami

recruiting coordinator

lead clinical research coordinator

Doctors Research Network

Organization: Doctors Research Network<ul><li>Sponsor interactions, and study team communications.</li><li>Quality Assurance: Proactively identify and resolve study-related issues; maintain compliance with SOPs, FDA, GCP, and HIPAA standards.</li><li>Fluency in Spanish is required</li></ul>About Doctors Research NetworkDoctors Research Network is a leading clinical research organization committed to advancing science and improving patient outcomes through high-quality, ethical, and efficient clinical trials. Our network partners with top physicians, sponsors, and CROs to deliver cutting-edge research across a wide spectrum of therapeutic areas. We are seeking a highly skilled Senior Clinical Research Coordinator (CRC) to join our Miami team and help drive the success of our expanding research portfolio.Position OverviewThe Senior Clinical Research Coordinator will play a pivotal role in the planning, execution, and oversight of clinical trials, ensuring compliance with FDA regulations, GCP/ICH guidelines, IRB requirements, and study protocols. This individual will serve as a subject matter expert, mentor junior staff, and act as the primary liaison between investigators, sponsors, CROs, and patients.Key Responsibilities<ul><li>Protocol Management: Coordinate and manage all aspects of assigned clinical trials from start-up through closeout, ensuring strict adherence to protocol requirements.</li><li>Regulatory Compliance: Prepare, submit, and maintain IRB/EC submissions, regulatory documents, and essential study files.</li><li>Participant Oversight: Screen, consent, and enroll eligible participants; schedule visits; conduct study assessments; and maintain accurate source documentation.</li><li>Data Integrity: Ensure timely, complete, and accurate data entry into EDC systems; respond to queries promptly; and participate in data audits/monitoring visits.</li><li>Site Leadership: Serve as lead coordinator on complex studies; mentor and train CRCs, research assistants, and support staff.</li><li>Collaboration: Act as primary contact with sponsors and CROs; coordinate site visits, monitor.</li><li>Operational Efficiency: Assist with budgeting, study feasibility assessments, and resource allocation to optimize site performance.</li></ul>Qualifications<ul><li>Bachelor&rsquo;s degree in life sciences, nursing, or a related field required; advanced degree or RN preferred.</li><li>Minimum 3 years of clinical research coordination experience (multi-site or multi-therapeutic area preferred).</li><li>Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial operations.</li><li>Experience with EDC systems, CTMS, and eRegulatory platforms.</li><li>Excellent organizational skills with the ability to manage multiple trials simultaneously.</li><li>Proven track record of mentoring junior staff and leading site-level operations.</li><li>Exceptional interpersonal skills to engage patients, investigators, and sponsor/CRO partners effectively.</li><li>Bilingual (English/Spanish) a MUST.</li></ul>Why Join Us<ul><li>Opportunity to work on innovative, high-impact clinical trials with leading physicians and sponsors.</li><li>Collaborative and mission-driven environment focused on quality and patient care.</li><li>Competitive compensation.</li><li>Career advancement within a growing clinical research network.</li></ul>Job Type: Full-timePay: $24.00 - $30.00 per hourBenefits:<ul><li>Paid time off</li><li>Professional development assistance</li></ul>Experience:<ul><li>Clinical research: 3 years (Preferred)</li></ul>Language:<ul><li>Both English and Spanish (Required)</li></ul>License/Certification:<ul><li>Current GCP, IATA, Phlebotomy certification (Preferred)</li></ul>Work Location: In person

Senior Clinical Research Coordinator

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 1
The University of Miami/UHealth department of Neurology has an exciting opportunity for a Full Time Clinical Research Coordinator 1 to work at the UHealth Medical Campus. The Clinical Research Coordinator 1 (A) serves as an entry-level clinical research professional that has a foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. The incumbent is responsible for simple clinical research protocols and timelines.
Core Responsibilities
<ul><li>Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.
</li><li>Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
</li><li>Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.
</li><li>Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.
</li><li>Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.
</li><li>Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
</li><li>Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
</li><li>Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
</li><li>Knows the contents and maintenance of study-specific clinical research regulatory binders.
</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
<ul><li>Attend the scheduled clinical research meetings with Clinical Research Supervisor and fellow CRCs.
</li><li>Assists in keeping accurate accountability of clinical research costs: reimbursement/payments to study participants, payments to third parties, including but not limited to the costs of conducting clinical research at JHS, University of Miami facilities (Radiology, Research Pharmacy, Radiology, Laboratory, Clinical and Translational Research Services).
</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
</li><li>Minimum 1 year of relevant experience
</li></ul>Knowledge, Skills and Attitudes:
<ul><li>Skill in completing assignments accurately and with attention to detail.
</li><li>Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
</li><li>Ability to process and handle confidential information with discretion.
</li><li>Ability to work evenings, nights, and weekends as necessary.
</li><li>Commitment to the University&rsquo;s core values.
</li><li>Ability to work independently and/or in a collaborative environment.
</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 1

Evolution Research Group

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

Clinical Research Coordinator (CRC)-FT

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

<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 .
 The University of Miami/UHealth Department of OBGYN has an exciting opportunity for a full-time Clinical Research Coordinator 2 to work in Miami, FL. 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.
<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 JOB FUNCTIONS
<ul><li>Reviews and administers informed consent forms to study participants.
</li><li>Schedules patients for research-related visits and contacts patients for clinical follow-up requirements.
</li><li>Coordinates activities between departments to accomplish study goals.
</li><li>Assists investigators in study related tasks, follow-up visits, procedures, and assessments as required per protocol
</li><li>Maintains updated records of long-term follow-up participants, collect and required data on a timely manner respond to sponsor queries Retains records of payments to study participants.
</li><li>Completes patients&rsquo; data forms and reviews medical charts for patients&rsquo; vital signs and other medical data to complete case report forms.
</li><li>Complete and manage regulatory binder documents according to protocol and institutional requirement
</li><li>Complete study related activities such as device management, device insertion and removal.
</li><li>Maintains records of study results and study participants. Keeps an active pool of study candidates to ensure availability.
</li><li>Coordinates the implementation of multiple complex clinical research protocols.
</li><li>Develops SOPs and templates with guidance from the PI/Clinical Research Nurse Manager.
</li><li>Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.
</li><li>Manages and performs sample collection, processing, packing, and shipping according to protocol, applicable standards, and regulations.
</li><li>Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations.
</li><li>Develops and implements preventive/corrective actions.
</li><li>Develops, disseminates, and assures adherence to study-related clinical research best practices
</li><li>Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.
</li><li>Organizes/manages site visits and internal/external auditing activities as assigned.
</li><li>Coordinates research team meetings; assures communications across-the-board.
</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>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><li>Refer to department description for applicable certification requirements
</li><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>This is a core job profile description and is not reflective of all duties that may be assigned to a specific position in each individual department. The above statements are intended to describe the general nature and primary responsibilities of this core job profile. Specific duties and tasks may vary based upon departmental needs. Other duties may be assigned to the above consistent with the knowledge, skills, and abilities required for the job.
#LI-NN1
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

Gastro Health

<div>
 
 Gastro Health is seeking a Full-Time Research Assistant to join our team!
 
 
 
 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.
 
 
 
 This Role Offers
 
 
 
 <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
 
 
 </li>
 </ul>
 
 Duties You Will Be Responsible For
 
 
 
 <ul>
 <li>
 General Administrative Provides assistance to Clinical Research Coordinators, local site, and Central Hub in accordance with federal regulations and sponsoring agency policies and procedures in compliance with Good Clinical Practice.
 </li>
 <li>
 Performs activities in accordance with established policies and procedures related to clinical research study protocols, including but not limited to: answering phone calls, screening participants for eligibility, and registering subjects in Real Time.
 </li>
 <li>
 Responsible for organizing the lab, and maintaining inventory of clinical supplies such as lab kits, phlebotomy supplies.
 </li>
 <li>
 Assist in ensuring that study materials and lab kits are shipped and resupplied as requested.
 </li>
 <li>
 Supports members of study/project teams; reviews source documents, reviews clinical procedures, drafts new procedures or revisions to existing procedures.
 </li>
 <li>
 Participate in ongoing clinical and study specific training.
 </li>
 <li>
 Communicates, as necessary with vendors and supporting functions at site level.
 </li>
 <li>
 Any other task assigned by the Clinical Research Coordinators and Central Hub Protocol Preparation &amp; Review Attends investigator meetings as required or requested by the PI and Clinical Research Coordinator.
 </li>
 <li>
 Responsible for compiling source documents for active studies and ensuring source binders contain the appropriate documentation to screen upcoming patients. Prepares other study materials as requested necessary.
 </li>
 <li>
 Collects data as required by the protocol.
 </li>
 <li>
 Assures timely completion of Source Documents.
 </li>
 <li>
 Responsible for processing and shipping labs.
 </li>
 <li>
 Responsible for assisting in EDC completion.
 </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>
 Maintains effective and ongoing communication with the PI, Clinical Research Coordinators, and research participants during the course of the study.
 </li>
 <li>
 Supports members of study/project teams; reviews source documents, reviews clinical procedures, drafts new procedures or revisions to existing procedures.
 </li>
 <li>
 Works with the PI under the Clinical Research Coordinator to manage the day to day activities of the study including problem solving, communication and protocol management.
 </li>
 <li>
 Project Closeout Assists the Principal Investigator,
 </li>
 <li>
 Clinical Research Coordinator and Regulatory Specialist with archival of study records in accordance with federal regulation, Gastro Health Research policies, and sponsoring agency policies and procedures.
 
 
 </li>
 </ul>
 
 Minimum Requirements
 
 
 
 <ul>
 <li>
 High School Diploma
 </li>
 <li>
 Research experience preferred
 
 
 </li>
 </ul>
 Interested in learning more? Click here to learn more about the location.
 
 
 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.
 
 
 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.
 
 
 We thank you for your interest in joining our growing Gastro Health team!
</div>

Research Assistant

<div>TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
Join Our Team as a Clinical Research Manager (CRM) - home based in East Coast, US.
If you have a minimum of 5 years clinical operation experience in a CRO setting (plus no less than 1 year of CRM experience) with at least 1+ year of OPH experience and are fluent in Spanish and English - we want to hear from you!
About this role
As part of our CDS Ophthalmology team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals. 
 
The Clinical Research Manager (CRM) is is part of Clinical Operations Unit within TFS Clinical Development Services and will function operationally as a member of a Project Team being responsible of coordinating and overseeing the country and site management activities during study conduct, according to company policies, SOPs, and regulatory requirements in addition to financial and contractual obligations.
The CRM will be reporting to the Project Manager being responsible of certain aspects of project activities which may include country and site tracking, monitoring plans, review of monitoring reports and study monitoring resources management.
Key Responsibilities:<ul><li>
Project oversight and responsibility over clinical operations deliverables</li><li>
Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to the applicable SOPs, protocol requirements, study specific plans, ICH/GCP and all other applicable laws, rules, and regulations.</li><li>
Serve as primary Sponsor contact for operational project-specific issues and study deliverables.</li><li>
Lead, manage and guide CRAs ensuring all necessary project-specific training is provided, carried out, and documented.</li><li>
Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables.</li><li>
Development of Study Monitor plans, Monitor and Site Training plans, verification initiatives, coordinating Study Investigator Meetings and reviewing site and country Study Reports.</li><li>
Ensure study processes, procedures and expectations correspond to the practicality of conducting the trial from study feasibility through to close out.</li><li>
Serve as initial point of contact for the monitoring team and support them with investigative site personnel liaison.</li><li>
Implement monitoring/recruitment plans and support also the design of CRF completion guidelines.</li><li>
Perform co-monitoring visits as part of the monitoring team quality oversight.</li><li>
Review and approve site visit reports (PSV, SIV, MV and COV) with agreed and act as first point of contact for issue escalation ensuring the proper resolution and action plan definition and follow up.</li><li>
Review CRA Site Visits calendar ensuring monitoring visits (both remotely and on site) are being scheduled and conducted following monitoring plan frequency.</li><li>
Reviewing protocol deviations and data listings for studies to ensure reliable quality data are delivered and proactive identifies and solves issues/concerns.</li><li>
Leading and guiding the internal clinical study team and chairing study team meetings.</li><li>
Update the Project Manager with status of sites and countries and ensure a proper escalation of any issue detected at site/country level.</li><li>
Ensure documents remain current during the trial and ensure proper maintenance of Trial Master File being responsible of QC when delegated by Project Manager</li></ul>
Qualifications:<ul><li>
Degree in clinical, science or health related field</li><li>
5+ years of clinical research experience, as a CRA, including relevant on-site monitoring experience.</li><li>
Minimum of 5 years clinical operation experience in a CRO setting (plus no less than 1 year of CRM experience) with at least 1+ year of OPH experience - this is mandatory</li><li>
Able to work in a fast-paced environment with changing priorities.</li><li>
Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas.</li><li>
In-depth knowledge of applicable clinical research regulatory requirements Good Clinical Practice, ICH guidelines</li><li>
Ability to work independently as well as in a team matrix organization and multiple projects.</li><li>
Excellent English and Spanish written and verbal communication skills as well as computer skills</li><li>
Excellent organizational and leadership skills</li><li>
Ability and willingness to travel up to 20-30%</li></ul>
What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You&rsquo;ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
A Bit More About Us
Our journey began over 29 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.
Together we make a difference.</div>

Clinical Research Manager (CRM) - Spanish Speaker

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Clinical Research Manager (CRM) - Spanish Speaker