clinical research specialist

University of Miami

<div><h2 class="jobSectionHeader">Current Employees:
</h2>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 using the Career worklet, please review this tip sheet .
The University of Miami/UHealth Department of SCCC CRS has an exciting opportunity for a Full Time Clinical Research Data Specialist to work at the UHealth campus in Miami, Fl.
CORE JOB SUMMARY
 
The Clinical Research Data Specialist assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures, under the supervision of the Principal Investigator (PI) and supervisor. The Clinical Research Data Specialist is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to SOPs, and all applicable regulations and guidelines.
 
 
CORE JOB FUNCTIONS
 
1. Extracts clinical data and research data from electronic medical records and other sources and enters this data in the clinical paper-based or electronic data capture system for each assigned study.
 
2. Manages a workload of studies commensurate to level of experience
 
3. Answers data clarifications (i.e., data queries) for each study.
 
4. Schedules and meets with study monitors and assures patient cases are ready for each monitor visit and items are addressed after each monitoring visit.
 
5. Develops source data worksheets specific to each assigned study.
 
6. Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit.
 
7. Assures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines.
 
8. Maintains logs (i.e., TAS submissions, Velos etc.) in a timely manner according to department SOPs.
 
9. Participates in site initiation visits (SIV), monitoring visits and participates in site disease group (SDG) team and PI oversight meetings as required.
 
10. Assists multidisciplinary team in research activities.
 
11. Maintains study binders and filings according to protocol requirements and department policy.
 
12. Adheres to all UM and department policies and procedures.
 
13. Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment.
 
14. Maintains screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.
 
15. Ensures work environment is organized and functions efficiently. Participates in a collaborative, empowered work environment as demonstrated through teamwork. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center.
 
16. Adheres to University and unit-level policies and procedures and safeguards University assets.
 
 
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
 
Education:
 
High School Diploma or equivalent/relevant experience, certification or license
 
 
Experience:
 
No previous experience required
 
 
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>Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders. 
<li>
</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 - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.
Job Status:
Full time
Employee Type:
Staff
Pay Grade:
A6</div>

Clinical Research Data Specialist

Johnson & Johnson

<div>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
MedTech Sales
Job Sub Function:
Technical Sales - MedTech (Commission)
Job Category:
Professional
All Job Posting Locations:
Boston, Massachusetts, United States of America, Chicago, Illinois, United States, Dallas, Texas, United States, Danvers, Massachusetts, United States of America, Los Angeles, California, United States of America, New York, New York, United States, Orlando, Florida, United States of America
Job Description:
About Cardiovascular
Fueled by innovation at the intersection of biology and technology, we&rsquo;re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that&rsquo;s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
This is a field-based role available in all states/cities within United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
We are searching for the best talent for Field Research Specialist.
Purpose: We are seeking an experienced, high caliber Field Research Specialist, this is a field-based position for the U.S. Preferred candidates will be located near a major airport and have a strong clinical background in procedural areas.
The Field Research Specialist is a dual-role position that combines field-based clinical research engagement, technical expertise in medical device support, and on call, bedside clinical support. This individual serves as a critical bridge between research operations, clinical trial execution, and procedural/device support.
This individual will be responsible for driving clinical trial enrollment, retention, and building trusted partnerships with investigators, coordinators, and multidisciplinary teams. They will optimize patient safety, mitigate trial enrollment barriers, and ensure robust data integrity. Collaborating cross-functionally with JNJ Heart Recovery stakeholders and leveraging strong relationships with clinical site personnel including physicians, nurses, and clinical research specialists, the FRS supports site selection and startup, drives patient recruitment, ensures protocol and data compliance, provides on call bedside technical/device support for clinical procedures, supports challenging technical/protocol troubleshooting scenarios, critical software or product testing, and site closeouts.
As a subject matter expert on clinical trial protocol and technologies, the Field Research Specialist acts a liaison between Abiomed and the medical community, constantly communicating important information to investigators and customers &ndash; and parlaying clinical trial experience, knowledge, and feedback (&ldquo;Voice of Investigator&rdquo;) to Abiomed cross-functional partners such as R&amp;D, medical affairs, marketing, sales, and education.
You will be responsible for:<ul><li>
Provides field support for clinical research related enrollment and procedures.</li><li>
Serve as a technology, protocol and clinical trial procedure expert and resource Abiomed stakeholders, physicians, and research personnel at the site.</li><li>
Develop and maintain in depth knowledge of clinical trial sites.</li><li>
Understand and assess investigators&rsquo; interests and qualifications.</li><li>
Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code.</li><li>
Maintain open communication and relationships with key site personnel including the Principal Investigator, Research Coordinator, as well as regulatory and legal personnel.</li><li>
Proactively and critically examine ways to enhance overall clinical trial performance.</li><li>
Facilitate communication between clinical trial sites and other Abiomed clinical staff (e.g., CRA, study team, Contracts Associate), as needed.</li><li>
Manage the following aspects of study progress, including, but not limited to:<ul><li>
Start Up</li><li>
Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.</li><li>
Facilitate contract/budget escalations as part of the start-up process</li><li>
Train facility staff regarding protocol requirements and technology.</li><li>
Develop site-specific strategies to promote appropriate patient enrollment. Identify site successes and challenges and assist in implementing troubleshooting techniques that promote study goal achievement.</li><li>
Provide ongoing feedback concerning all aspects of study progress, specifically enrollment and procedure related, for the purpose of developing and implementing strategies that will optimize patient safety and contribute to organizational and corporate goals/objectives.</li></ul></li><li>
Provide support for all study-related aspects to research partners, including but not limited to the following questions: technical, protocol, standard of care, clinical trial reimbursement, etc.</li><li>
Provides on call, bedside case coverage for multiple clinical trials and clinical trial sites.</li><li>
Provides back up support in the following areas, trouble shooting, in-service training to physicians and healthcare professionals.</li><li>
Responsible for product reporting and troubleshooting with customers and field personnel within the clinical research portfolio.</li><li>
Collaborate with and provide feedback to Clinical Scientists and study teams in the development of clinical study deliverables, such as protocol design, source documentation, work instructions, patient recruitment materials and product training.</li><li>
Identify and communicate best practices relevant to clinical trial execution.</li><li>
Seek opportunities to continue demonstrating and developing technical, research, and organizational leadership qualities.</li><li>
Collaborate with Clinical Affairs, Medical Affairs, R&amp;D, marketing, and commercial teams to support and advance key projects.</li><li>
Serve as a scientific interface with healthcare professionals.</li><li>
Act as resource in corporate product education as it relates to investigative technologies, as necessary: development, review, and initiation and maintenance of vault approval of training materials, presentations, regional and national product launches, and commercial field education.</li><li>
Develop collaborative cross-divisional team relationships.</li><li>
Provides engineering, education and clinical support in response to field-based inquiries on as needed basis.</li><li>
Transfers clinical trial knowledge and experience into meaningful input and feedback to cross functional partners in R&amp;D, medical affairs, marketing, sales, and education.</li><li>
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
</li></ul>Qualifications/Requirements
<ul><li>Bachelor&rsquo;s degree in engineering, nursing, biological sciences, a related field, equivalent or related certification in cardiology.</li><li>
Typically, a minimum of 5 years of relevant clinical experience, with in-depth knowledge of cardiology, and related cardiovascular technologies</li><li>
Direct patient support in Cath lab and operating room is a plus.</li><li>
Availability for to work on call for emergent clinical trial support required.</li><li>
Ability to work in a highly matrixed and geographically diverse business environment.</li><li>
Ability to leverage and/or engage others to accomplish projects.</li><li>
Advanced verbal and written communications with ability to effectively communicate at multiple levels in the organization. Exceptional presentation and influence skills.</li><li>
Required clinical research experience in medical devices.</li><li>
Knowledge of Good Clinical Practices and trials, including feasibility IDE.</li><li>
Multitasks, prioritizes, and meets deadlines in timely manner.</li><li>
Strong organizational and follow-up skills, as well as attention to detail.</li><li>
Ability to travel approximately 70% domestically.</li></ul>
Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Communication, Customer Centricity, Innovation, Market Expansion, Market Research, Medicines and Device Development and Regulation, Proactive Behavior, Problem Solving, Product Knowledge, Sales Engineering, Solutions Selling, Strategic Sales Planning, Sustainable Procurement, Vendor Selection</div>

Field Research Specialist

SearchPlus HR

A healthcare recruitment agency is seeking a Specialist / Consultant in Stroke Medicine in Sharjah. You'll diagnose and manage stroke patients, work with a multidisciplinary team, and contribute to clinical research. The ideal candidate will hold an MD or equivalent and have board certification in Stroke Medicine. This role offers a competitive salary and benefits including private health insurance and training opportunities.

Stroke Medicine Specialist: Lead Care & Research

Thomas Jefferson University & Jefferson Health

<div>Job Details
The Senior Academic Research Specialist leads the design, preparation, and implementation of research projects for Residents, Fellows, and Faculty across the Departments of Medicine and Surgery, ensuring high-quality scholarly output and timely project completion. This role provides advanced expertise in research methodology, data management, statistical analysis, and the development of abstracts, manuscripts, and presentations, while also contributing to resident education as adjunct faculty. The Specialist supports key academic initiatives&mdash;including the Internal Medicine Resident Research Symposium&mdash;and offers administrative and methodological guidance for conference participation and external presentations. Additionally, the Senior Academic Research Specialist plays a vital role in cultivating a strong research culture by mentoring trainees, supporting grant and funding activities, and upholding institutional standards for academic excellence.
Job Description
Essential Functions
<ul><li>Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson.
</li><li>Supervises and coordinates to completion, research projects for Residents, Fellows, and Faculty in the Departments of Medicine and Surgery by assisting in research design, proposal writing, and in creation of Institutional Review Board (IRB) documents.
</li><li>Supervises and coordinates to completion acquisition, analysis and submission of research data as it pertains to research projects for Residents, Fellows, and Faculty in Departments of Medicine and Surgery. Assists Residents, Fellows, and Faculty in the preparation of abstracts, manuscripts, posters and presentation materials to promote timely submission of completed research.
</li><li>Teaches research design and methods to Medicine and Surgery Residents at Jefferson Abington Hospital.
</li><li>Participates in semimonthly Resident Journal Club for the Department of Medicine and Department of Surgery as needed.
</li><li>Supervises Resident elective in Research and provides Resident evaluation and performance assessment to measure skill achievement for purposes of promotion and requirement completion.
</li><li>Possesses knowledge of research design, survey instruments and statistics. Develops survey instruments and data collection methods for entry into statistical program databases. Analyzes data with appropriate parametric and non-parametric statistics using available software such as SPSS. Teaches and supervises use of graphical displays of data in research presentations and publications to assist Residents, Fellows, and Faculty.
</li><li>Coordinates submission for and is administrative support for Internal Medicine Resident Research Symposium. Serves as key administrative support for external conferences and presentations involving Resident research.
</li>Assists in grant writing or other research funding activities to support Resident Research projects. 
<li>
</li></ul> 
Competencies (Knowledge, Skills, and Abilities Required):
<ul><li>Strong interpersonal and communication skills required;
</li><li>Facile with computerized statistical analysis software required;
</li><li>Demonstrated skills in team building.
</li></ul>Minimum Education and Experience Requirements:
Education:
<ul><li>Master&rsquo;s degree in science or related field; PhD degree preferred.
</li></ul>AND
Experience:
10+ years&rsquo; experience in academic research support and design activities; must have experience in medical-related or clinical research. Teaching experience required; 
<ul><li>
</li></ul> 
Minimum Certifications, Registration or License Requirements:
CITI training; licensed clinician preferred 
<ul><li>
</li></ul> 
Additional Information
<ul><li>Experience with grant writing and manuscript writing strongly preferred.
</li></ul>Work Shift
Workday Day (United States of America)
Worker Sub Type
Regular
Employee Entity
Abington Memorial Hospital
Primary Location Address
1200 Old York Road, Abington, 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, please click here</div>

Sr. Academic Research Spclist

Bristol Myers Squibb

Working with Us 
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 
 
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . 
 
Job Title
 
Clinical Trial Registration Sr. Specialist 
Division
 
Research &amp; Development
 
Functional Area Description
 
Global Development Operations / Trial Delivery Support (TDS) / Trial Risk and Integrity Management (TRIM)/ CT Transparency &amp; Submission
 
Position Summary / Objective
 
The Clinical Trial Registration Sr. Specialist will report to the Clinical Trial Registration Lead, prepare and provide operational support for the registration and maintenance of clinical trials into public registries in US, EU and other countries as required. 
Position Responsibilities
 
Drives the processes for assigned protocol registration activities, resulting in timely, high-quality information posted on clinical trial registries (Clinicaltrials.gov and EU PAS).
 
 
Liaises with clinical team reviewers (Global Trial Managers, Operations Leads, Statisticians, Clinical Trial Physicians, Clinical Scientists, Development Leads, Patent Attorneys) and other stakeholders on all assigned trials to ensure trial registrations are accurate, consistent with the protocol and other source data, and reported in adherence to NIH guidelines.
 
 
Provides maintenance support to CT Registration Lead for assigned records, to ensure the consistent accuracy of information disclosed on Clinicaltrials.gov.
 
 
Submits registration updates to Clinicaltrials.gov on behalf of clinical team, within global regulatory timelines.
 
 
Maintains study trackers and ensures they are up to date every week.
 
 
Educates stakeholders, as needed, on NIH detailed review criteria for registrations as well as on the purpose and format of the different fields in the protocol registration form.
 
 
Support registration of clinical trials in public registries beyond US/EU as needed.
 
Degree Requirements
 
Bachelor's degree, preferably in a Science-related field
 
Experience Requirements
 
Minimum of 3 years overall work experience, preferably in a biopharmaceutical or CRO company
 
 
Work experience in quality, regulatory, compliance, clinical research or drug development highly desirable
 
 
Work experience in clinical trial transparency or clinical trial execution work, or work experience related to quality and compliance in clinical research preferred
 
Key Competency Requirements
 
Demonstrated Excel and analytical skills
 
 
Ability to work in a multi-functional team and across multiple therapeutic areas
 
 
Demonstrated ability to work independently and seek out support when needed&quot;&quot;
 
 
Written and oral communication skills&quot;&quot;
 
 
Strong organizational skills with the ability to multitask and prioritize, and take on new initiatives and improvement efforts. 
 
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
 
 
Uniquely Interesting Work, Life-changing Careers 
With a single vision as inspiring as Transforming patients' lives through science&trade; , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 
 
On-site Protocol 
 
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
 
 
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
 
 
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
 
 
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
 
 
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. 
 
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
 
 
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Clinical Trial Registration Specialist

Virginia Commonwealth University

<div><div><div><h3 class="jobSectionHeader">Sr. Clinical Research Coordinator - School of Medicine, Neurology
</h3><div><div><ul><li>45001106
</li></ul></div><div><ul><li>907 Floyd Avenue, MCV Main Campus, Virginia, United States, 23284
</li></ul></div><div><ul><li>Research
</li></ul></div><div><ul><li>Staff
</li></ul></div><div></div><div><ul><li>School Of Medicine MBU</li></ul></div></div><div> 
</div><div>Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU&rsquo;s sponsored research, the School of Medicine is internationally recognized for patient care and education. Virginia Commonwealth University is an equal opportunity employer. 
 
https://vcujobs.com/why-richmond

Benefits: All full-time university staff are eligible for VCU&rsquo;s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave granted up front, generous tuition benefits, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more.

Unit: School of Medicine

Department: Neurology

Duties &amp; Responsibilities:

This position would serve as the Sr. Clinical Research Coordinator for the Center for Inherited Myology Research Program. This program is responsible for developing disease modifying and other innovative therapies for individuals with muscular dystrophy. In this role, the incumbent works with a group that leads an international network aimed at achieving this objective. 
For all clinical research studies assigned, the Sr. Clinical Research Coordinator is responsible for coordinating clinical research activities in a compliant and efficient manner from study initiation to close out. Under the direction of the Principal Investigator (PI), collaborates with all members of the clinical research team to ensure all federal, state, university and protocol requirements are followed, institutional research objectives are met, and that ethical obligations are kept. Core responsibilities are listed below along with other tasks and duties as assigned.

Core Responsibilities:

Responsibility 1 (30%): Research and Clinical Trial Coordination/Study Conduct
<ul>
<li>Independently coordinate study recruitment activities: pre-screening, screening</li>
<li>Access allowable data capture/retrieval systems and interact with a variety of health care delivery systems to identify potential study participants</li>
<li>Conduct and document the initial and ongoing informed consent process for research participants throughout study participation and follow up</li>
<li>Coordinate the enrollment of participants, coordinate and file randomization documents; notifying applicable individuals of registration/randomization (PI, participant, study team, pharmacist, etc.)</li>
<li>Support the PI and other study staff in following study participants through all study activities to ensure that the study is conducted in compliance with all requirements</li>
<li>Support the orientation and training of new research team members and other staff</li>
<li>Work with PI and program staff to ensure all required study close-out activities are complete</li>
<li>For assigned studies, coordinate clinical research processes and documentation which may include: filing and office organization, creation of job aids, conducting protocol related training, research participant scheduling, ordering of study materials and supplies, and scheduling of meetings</li>
</ul>
Responsibility 2 (25%): Regulatory and Compliance Requirements
<ul>
<li>Understand and adhere to all human subject protection and IRB regulations required for clinical research</li>
<li>Understand duty to report obligations related to research conduct, and the appropriate university channels for reporting concerns</li>
<li>Participate in meetings with internal and sponsor appointed monitors to ensure accuracy of subject data and compliance with research protocol and regulatory requirements</li>
<li>Coordinate auditing and monitoring activities for assigned studies</li>
</ul>
Responsibility 3 (25%): Data Management
<ul>
<li>Assist PI and study team members in the management of study data for new and ongoing clinical research studies assigned</li>
<li>Maintain study files according to GCP guidelines and in audit ready condition</li>
<li>For assigned studies, ensure subject data is entered into sponsor case report forms, databases and VCU systems in a timely manner and in accordance with sponsor and university</li>
<li>Review and respond to all queries within required time frames, seeking input from PI&rsquo;s and other study staff as appropriate</li>
</ul>
Responsibility 4 (20%): Clinical Skills
<ul>
<li>Complete VCUHS orientation and training modules as required for the department and clinical research projects</li>
<li>Conduct applicable clinical activities only as approved and required for each clinical research project</li>
<li>All clinical skills must be conducted in VCUHS approved clinical areas only. Any protocol required clinical skill requires current VCUHS competency verification/documentation prior to performing each activity</li>
<li>Must maintain all required VCU and VCUHS competencies related to performing research related clinical skills</li>
<li>Cannot perform any tasks that by state or local law require a license to perform, unless such license is on file and approved by VCU and VCUHS</li>
<li>Phlebotomy, vital signs, electrocardiograms and point of care testing will be a routine part of the job; hence the requirement for formal clinical education, experience and an active license</li>
</ul>
Qualifications:

Minimum Qualifications
<ul>
<li>Bachelor&rsquo;s Degree (health or life sciences, nursing or similar) or equivalent related 5+ years experience</li>
<li>Ability to obtain Clinical Research Coordinator certification (CCRC, CCRP, CCRA) within one year of hire date</li>
<li>Ability to obtain CNA, CMA or EMT within 6 months of hire date</li>
<li>Highly competent with computer software, including database, spreadsheet and word processing applications</li>
<li>Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU</li>
</ul>
Preferred Qualifications
<ul>
<li>Master&rsquo;s Degree (health or life sciences, nursing or similar)</li>
<li>RN, LPN, CAN, CMA or EMT with active license</li>
<li>Experience in human subjects research in participants with neurological disorders</li>
<li>Familiarity with eTMF software, RedCap, RedCap Cloud and/or other EDC</li>
<li>Experience administering validated survey instruments</li>
</ul>
Salary Range: $70,000 - $80,000

FLSA Exemption Status: Exempt 
 
Hours per Week: 40

Restricted Position: Yes

ORP Eligible: No

Flexible Work Arrangement: Fully Onsite

Contact Information: 
Contact Name: Kelly Barnes 
Contact Email: Kelly.Cecil@vcuhealth.org</div></div></div></div>

Sr. Clinical Research Coordinator - School of Medicine, Neurology

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Sr. Clinical Research Coordinator - School of Medicine, Neurology