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clinical trial coordinator

Houston Methodist

<div>At Houston Methodist, the Research Coordinator position is responsible for coordinating the day-to-day activities of research protocols as well as assessing and determining qualification of patients for research studies. This position ensures accurate data collection, documentation, organization and safety of research participants.
<div>FLSA STATUS 
Exempt 
 
QUALIFICATIONS 
 
EDUCATION<ul><li>
Bachelor&rsquo;s degree
</li></ul> 
EXPERIENCE<ul><li>
Two years&rsquo; research experience
</li></ul> 
SKILLS AND ABILITIES<ul><li>
Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
</li><li>Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
</li><li>Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
</li><li>Sufficient in clinical and research data entry
</li><li>Capable of handling challenging/difficult situations
</li>Demonstrates sound judgment and executes analytical skills 
<li>
</li></ul> 
 
ESSENTIAL FUNCTIONS 
 
PEOPLE ESSENTIAL FUNCTIONS<ul><li>
Under the direction of higher level staff, conducts screening and interviews to evaluate patient eligibility in study.
</li><li>Promotes a positive work environment and contributes to a dynamic, team focused work unit that actively helps one other to achieve optimal department results. Collaborates with all members of the patient care team by actively communicating and reporting pertinent information as it relates to assigned system(s) in a comprehensive manner.
</li><li>Provides contributions towards improvement of department scores for employee engagement.
</li></ul> 
SERVICE ESSENTIAL FUNCTIONS<ul><li>
Responds promptly and accurately to customer complaints, inquiries, and requests for information and coordinate appropriate follow-up calls and/or appointments.
</li><li>Schedules research subject appointments for tests and procedures, such as laboratory tests, x-rays, and other studies specific for the research protocol.
</li><li>Compiles patient information, process, document and enter accurate information in Source Documents, Case Report Forms, Electronic Data Capture portals and Clinical Trial Management System following established procedures.
</li></ul> 
QUALITY/SAFETY ESSENTIAL FUNCTIONS<ul><li>
Maintains records for clinical study and regulatory documents.
</li><li>Under the direction of Research Nurse/Clinical Trial Manager/Physician, captures and reports Adverse Events (A/E) or Serious Adverse Events (SAE) to necessary regulatory authorities.
</li><li>Assists management with research records and regulatory maintenance.
</li></ul> 
FINANCE ESSENTIAL FUNCTIONS<ul><li>
Uses resources efficiently; does not waste supplies. Evaluates and reports on inventory levels. Self-motivated to independently manage time effectively and prioritize daily tasks.
</li><li>Maintains inventory of supplies necessary for the study.
</li></ul> 
GROWTH/INNOVATION ESSENTIAL FUNCTIONS<ul><li>
Maintains working knowledge of the research process and in the conduct of IRB approved research protocols. Follows International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines.
</li>Seeks opportunities to expand learning beyond baseline competencies with a focus on continual development. Completes and updates My Development plan on an on-going basis. 
<li>
</li></ul> 
 
SUPPLEMENTAL REQUIREMENTS 
<ul>
WORK ATTIRE<li><ul><li>
Uniform: No
</li><li>Scrubs: Yes
</li><li>Business professional: No
</li><li>Other (department approved): Yes
</li></ul></li> 
ON-CALL* 
<li><ul><li>Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below.</li></ul></li><li><ul><li>
On Call* No
</li></ul></li> 
TRAVEL** 
**Travel specifications may vary by department**<li><ul><li>
May require travel within the Houston Metropolitan area No
</li><li>May require travel outside Houston Metropolitan area No
</li></ul></li></ul></div>QUALIFICATIONS 
 
EDUCATION<ul><li>
Bachelor&rsquo;s degree
</li></ul> 
EXPERIENCE
Two years&rsquo; research experience 
<ul><li>
</li></ul> 
Company Profile:
Houston Methodist Academic Institute oversees the Education Institute and Research Institute. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&amp;M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports clinical research protocols and extramurally funded translational research programs.
Houston Methodist is an Equal Opportunity Employer.</div>

Research Coordinator I

American Oncology Network

<div>Location:
Oncology Consultants
Pay Range:
$19.66 - $34.59<h1 class="jobSectionHeader">
Job Description Summary</h1>
Responsible for the performance of the research study under the medical supervision of the Principal Investigator. The Clinical Research Coordinator I (non-RN) is responsible for the overall successful implementation and ongoing management of the research studies. Ability to perform basics tasks and exhibit the knowledge of key aspects of clinical research at an essential or foundational level
Primary responsibility includes study designs with entry-level complexity (phase 4, observational/registry trial design) and associated study procedures. Administratively and clinically manage an average 5 clinical trials open to accrual annually and/or active (on study treatment) patient volume 2-10 annually.
Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.<h1 class="jobSectionHeader">
Primary Key Performance Areas</h1>
KPA 1 &ndash; Protocol Comprehension and Implementation: Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements.<ul><li>
Identify and explain key protocol elements and perform study tasks under direct supervision</li><li>
Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires</li><li>
Identifies and explains inclusion/exclusion criteria and the process of subject identification, prescreening, screening and re-screening</li><li>
Knowledge of the required elements of an informed consent form and the essential elements of the informed consent process.</li><li>
Review of diagnostic tests and related documentation required per protocol</li><li>
Follows process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events. Document different types of adverse events under direct supervision</li><li>
Ensures proper storage, dispensing, handling and destruction processes for investigational products.</li><li>
Follows process for handling investigational products that have been compromised.</li></ul>
KPA 2 &ndash; Regulatory and Data Integrity<ul><li>
Follows Institutional Review Board (IRB) / Independent Ethics Committee (IEC) review, approval and reporting requirements for the site. Maintains site credentials and ensures updated GCP, licenses remain on file
</li><li>Comply with reporting of safety related subject discontinuation and safety concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC.</li><li>
Collect, record and report accurate data and demonstrate per FDA guidelines, and review them against the patient&rsquo;s medical record for completeness and accuracy under direct supervision</li><li>
Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials</li><li>
Prepare documents for monitoring visits under direct supervision. Review visit monitoring follow-up reports / letters and perform requested activities.</li><li>
Escalates issues of protocol non-compliance to study PI and research department leadership</li></ul>
KPA 3 &ndash; Research Financial Practices: Budget/Contract execution and practices research billing compliance
<ul><li>Identifies elements of a study budget as it relates to execution of a protocol.</li></ul><h1 class="jobSectionHeader">
Position Qualifications/Requirements</h1>
Education<ul><li>
High school education required</li><li>
Some college is preferred</li></ul>
Previous Experience<ul><li>
Prior research or related medical science experience</li></ul>
Core Capabilities<ul><li>
Analysis &amp; Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.</li><li>
Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.</li><li>
Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.</li><li>
Customer Service &amp; Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.</li><li>
Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required.</li><li>
Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.</li></ul>
Computer Skills<ul><li>
Proficiency in MS Office Word, Excel, Power Point, and Outlook required.</li><li>
Prior experience with electronic medical records (EMR) is preferred</li><li>
Prior experience with clinical trial data entry systems (EDC) preferred</li><li>
Prior Clinical Trial Management Systems (CTMS) preferred.</li></ul><h2 class="jobSectionHeader">
Travel: 0%</h2>
Standard Core Workdays/Hours: Monday to Friday 8:00 AM &ndash; 5:00 PM.<h3 class="jobSectionHeader">
#AONC</h3></div>

Clinical Research Coordinator

Baylor College of Medicine

<div><div><div><div><h2 class="jobSectionHeader">Summary</h2></div><div>
The Department of Psychiatry is seeking a full-time research professional to support Primary Investigators (PIs) in the execution of clinical research studies. The selected candidate will work closely with PIs to support study operations, including data collection, data management, and assistance with data analysis. Responsibilities also include generating accurate analytical results and preparing findings in clear, well-organized written formats. 
This role requires the ability to work 100% on-site and flexibility to occasionally work early mornings or weekends based on patient visits.<div> 
This position is located on-site at Ben Taub Hospital&rsquo;s NeuroPsychiatric Center (NPC), 1502 Ben Taub Loop, Houston, TX 77030.</div></div></div><div><div><h2 class="jobSectionHeader"> 
Job Duties</h2></div><div><ul><li>
Independently manage 3&ndash;5 reliance psychiatric clinical trials (depression, anxiety, tardive dyskinesia, Alzheimer&rsquo;s disease, bipolar disorder, substance use disorders, and schizophrenia) as primary or backup study coordinator from start-up through close-out.</li><li>
Oversee patient enrollment, including recruitment, pre-screening, chart review, and informed consent.</li><li>
Serve as primary liaison between the Principal Investigator and study participants; educate participants on study protocols, risks/benefits, procedures, and expectations.</li><li>
Create source documents and collect medical, psychiatric, and medication histories.</li><li>
Administer cognitive batteries including MCCB, BACS, DSST, SCoRS, VRFCAT, WRAT-4, and ToL.</li><li>
Conduct psychiatric structured interviews including MINI, SCID, PANSS, HAM-D, MADRS, BPRS, C-SSRS, HAM-A, TLFB, PWC-20, ATRQ, CIWA-Ar, SDS, YMRS, MOAA-S, CADSS, MMSE, and CGI-I/S.</li><li>
Perform movement disorder scales including AIMS, BARS, and SAS.</li><li>
Collect vital signs, perform EKGs and venipuncture, and process and ship biological specimens.</li><li>
Monitor participant safety; document adverse events, serious adverse events, and protocol deviations in accordance with regulatory guidelines.</li><li>
Maintain participant retention through consistent communication and follow-up.</li><li>
Ensure accurate and timely data entry and query resolution.</li><li>
Register trial participants and research related visits in CTMS and generate invoices.</li><li>
Prepare for and participate in audits, site qualification, site initiation, monitoring, and closeout visits.</li><li>
Complete feasibility questionnaires and study start-up packets for new clinical trials.</li><li>
Coordinate with sponsors and CRO to facilitate protocol activities and maintain current study documentation.</li><li>
Maintain Investigator Site File for protocol amendments, investigators brochure, FDA Form 1572, delegation logs, training logs, and study manuals.</li><li>
Submit investigator applications to central IRBs. Prepare initial submissions, amendments, and renewals in Brain and e-Protocol systems.</li><li>
Perform additional research-related duties as assigned.</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Minimum Qualifications</h2></div><div><ul><li>
Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.</li><li>
Two years of relevant experience.</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Preferred Qualifications</h2></div><div><ul><li>
Master&rsquo;s degree or higher required (MD strongly preferred).</li><li>
Background in psychology, social work, or a related clinical field.</li><li>
Experience with assessments, particularly psychiatric or cognitive testing.</li><li>
Research experience preferred, especially in clinical or pharmaceutical studies.</li><li>
Exposure to patient-facing clinical environments.</li><li>
Familiarity with Epic is a plus.</li></ul></div></div></div> 
Work Authorization Requirement:
This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment. 
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</div>

Research Coordinator III - Psychiatry and Behavioral Sciences

<div>Location:
Oncology Consultants
Pay Range:
$15.83 - $26.38
RESPONSIBILITIES<ul><li>
Responsible for the submission of clinical trial data of research</li><li>
Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.</li></ul> 
QUALIFICATIONS
Education:<ul><li>
High school education required</li><li>
Some college is preferred</li></ul>
Certifications/Licenses:<ul><li>
Professional clinical research certification is preferred</li><li>
Valid state Driver&rsquo;s License for travel to satellite offices and offsite meetings. Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy is required.</li></ul>
Previous Experience:<ul><li>
3-5 years prior research experience preferred</li></ul>
Core Capabilities:<ul><li>
Analysis &amp; Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.</li><li>
Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.</li><li>
Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.</li><li>
Customer Service &amp; Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.</li><li>
Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required.</li><li>
Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.</li></ul>
Computer Skills:<ul><li>
Proficiency in MS Office Word, Excel, Power Point, and Outlook required.</li><li>
Prior experience with electronic medical records (EMR) is preferred</li><li>
Prior experience with clinical trial data entry systems (EDC) preferred</li><li>
Prior Clinical Trial Management Systems (CTMS) preferred.</li></ul>
Standard Core Workdays/Hours: Monday to Friday 8:00 AM &ndash; 5:00 PM.
#AONA</div>

Research Data Coordinator

UTHealth Houston

<div>The UTHealth Department of Pediatrics is seeking a Clinical Research Coordinator (CRC) I for the Social Needs Assistance for Hospitalized Kids (SNAK) Trial. This multisite trial examines the comparative effectiveness of 2 hospital-based interventions designed to address families&rsquo; social and economic issues. Under the supervision of the Primary Investigator (PI), the incumbent will work closely with study team including community liaison, and investigator team to coordinate the data collection and operations of clinical research studies under the guidelines of research protocols, UTHealth and regulating agency policies.
The study involves recruiting participants from hospital ward at Children&rsquo;s Memorial Hermann Hospital (CMHH) (at Texas Medical Center Campus). The key responsibilities of this position will be to provide support for participant recruitment, enrollment, and retention; study data collection; and connecting families to community-based resources. The individual will be responsible for activities related to patient follow-up including scheduling and administering surveys, managing study data, and incentive distribution.
Preferred Qualifications<ul><li>
Fully bilingual in Spanish and English (both speaking and writing).</li><li>
Experience and comfort working with children, adolescents, and families.</li><li>
Experience administering and distributing surveys with REDCap.</li><li>
Experience working with patients and families in healthcare settings.</li><li>
Experience extracting data from medical records and transfer it to data collection forms or directly into databases.</li></ul><ul><li>
Knowledge of any of the following: UTHealth policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, the UTHealth mission statement and purpose for research, UTHealth research policies and guidelines, policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.), and medical terminology.</li><li>
Experience applying the following regulations and guidelines:</li></ul><div>
Good Clinical Practice Guidelines</div><div>
Health Information and Accountability Act (HIPAA)</div><div>
The Protection of Human Research Subjects</div><div>
CHR regulations for recruitment and consent of research subjects</div>
Other duties may include but are not limited to; updating the research databases used to collect data, entering data, tracking participants, and other study-related participation; attending and actively participating in regular team meetings; monitoring study supplies; maintaining research files; and performing other related duties as assigned.
The incumbent would develop and maintain positive working relationships and partnerships with participants, colleagues, study recruitment sites, and other study collaborators. The individual will interact with multiple investigators, physicians, nurses, and community partners to ensure the successful implementation of on-going studies.
Shift Details: Monday &ndash; Friday. May require availability for 1&ndash;2 weekend days per month.
What we do here changes the world. UTHealth Houston is Texas&rsquo; resource for healthcare education, innovation, scientific discovery, and excellence in patient care. That&rsquo;s where you come in.
Once you join us you won't want to leave. It&rsquo;s because we reward our team for the excellent service they provide. Our total rewards package includes the benefits you&rsquo;d expect from a top healthcare organization (benefits, insurance, etc.), plus:<ul><li>
100% paid medical premiums for our full-time employees</li><li>
Generous time off (holidays, preventative leave day, both vacation and sick time &ndash; all of which equates to around 37-38 days per year)</li><li>
The longer you stay, the more vacation you&rsquo;ll accrue!</li><li>
Longevity Pay (Monthly payments after two years of service)</li><li>
Build your future with our awesome retirement/pension plan!</li></ul>
We take care of our employees! As a world-renowned institution, our employees&rsquo; wellbeing is important to us. We offer work/life services such as...<ul><li>
Free financial and legal counseling</li><li>
Free mental health counseling services</li><li>
Gym membership discounts and access to wellness programs</li><li>
Other employee discounts including entertainment, car rentals, cell phones, etc.</li><li>
Resources for child and elder care</li><li>
Plus many more!</li></ul>
Position Summary:
Assists with the day-to-day administrative project management and may provide scientific direction for research projects of considerable scope and complexity. 
Position Key Accountabilities:<ul><li>
Assists with the day-to-day project management coordination for research projects to include personnel, facilities, supplies in support of research project desired outcomes, budgets, and timeliness.</li><li>
Assists in the preparation of progress reports and grant proposals to both private foundations and governmental agencies; works closely with the Office of Sponsored Projects on the submission of grants.</li><li>
Assists with the preparation of budgets, initiates re-budgeting requests based on needs of research staff, and authorizes expenditures for multiple projects. Attends research-planning meetings to assist in the preparation of budget drafts for departmental leadership approval.</li><li>
Prepares annual progress reports and applications for various committees and ensures that all staff has received the proper training/attended the appropriate training courses.</li><li>
Maintains confidential records of collected data, ensures accuracy and integrity of data. Data may include patient data and departmental programmatic data.</li><li>
Prepares draft reports and communications for the departmental program/division leadership.</li><li>
Interacts with representatives from state, federal, and private agencies regarding proposals and funded projects.</li><li>
Provides work administrative direction and guidance to administrative staff personnel within department.</li><li>
May review contracts and develop training.</li><li>
Other duties as assigned.</li></ul> 
Certification/Skills:
Excellent communication skills both written and verbal. 
Working knowledge of MS Office.
Minimum Education:
Bachelor&rsquo;s degree in a related field or relevant experience in lieu of education.
Minimum Experience:
None
Physical Requirements:
Exerts up to 20 pounds of force occasionally and/or up to 10 pounds frequently and/or a negligible amount constantly to move objects. 
This position may include work involving potentially hazardous chemical, biological or radioactive agents.
Security Sensitive:
This position is a security-sensitive position pursuant to Texas Education Code &sect;51.215 and Texas Government Code &sect;411.094. To the extent that a position requires the holder to research, work on, or have access to critical infrastructure as defined in Texas Business and Commerce Code &sect;117.001(2), the ability to maintain the security or integrity of the infrastructure is a minimum qualification to be hired for and to continue to be employed in that position. Personnel in such positions, and similarly situated state contractors, will be routinely reviewed to determine whether things such as criminal history or continuous connections to the government or political apparatus of a foreign adversary might prevent the applicant, employee, or contractor from being able to maintain the security or integrity of the infrastructure. A foreign adversary is a nation listed in 15 C.F.R. &sect;791.4.
Residency Requirement:
Employees must permanently reside and work in the State of Texas.</div>

Research Coordinator I - Pediatrics (Hospital Medicine)

<div>We are hiring a Research Coordinator III (full-time) to join UTHealth Houston School of Public Health in Houston, Tx. In this role, you will will have the opportunity to supervise and execute vector control studies. The goal of this project is to develop CRISPR-based strategies to manage mosquito populations and reduce the impact of vector-borne diseases. Ideal candidate should have bioinformatic skills analyzing RNA sequencing and microbiome data.
What we do here changes the world. UTHealth Houston is Texas&rsquo; resource for healthcare education, innovation, scientific discovery, and excellence in patient care. That&rsquo;s where you come in.
Once you join us you won't want to leave. It&rsquo;s because we reward our team for the excellent service they provide. Our total rewards package includes the benefits you&rsquo;d expect from a top healthcare organization (benefits, insurance, etc.), plus:<ul><li>
100% paid medical premiums for our full-time employees</li><li>
Generous time off (holidays, preventative leave day, both vacation and sick time &ndash; all of which equates to around 37-38 days per year)</li><li>
The longer you stay, the more vacation you&rsquo;ll accrue!</li><li>
Longevity Pay (Monthly payments after two years of service)</li><li>
Build your future with our awesome retirement/pension plan!</li></ul>
We take care of our employees! As a world-renowned institution, our employees&rsquo; wellbeing is important to us. We offer work/life services such as...<ul><li>
Free financial and legal counseling</li><li>
Free mental health counseling services</li><li>
Gym membership discounts and access to wellness programs</li><li>
Other employee discounts including entertainment, car rentals, cell phones, etc.</li><li>
Resources for child and elder care</li><li>
Plus many more!</li></ul>
Position Summary:
Provides day to day administrative project management and may provide scientific direction for research projects of considerable scope and complexity. The Department of Epidemiology, at the UTHealth School of Public Health is seeking an exceptional 
candidate for Research Coordinator III position. This person will have the opportunity to supervise and 
execute vector control studies. The goal of this project is to develop CRISPR-based strategies to 
manage mosquito populations and reduce the impact of vector-borne diseases. Specifically, the 
Research Coordinator III position will employ Drosophila and Aedes aegypti insects to develop genetic 
tools that will increase our available toolkit for controlling mosquito populations. This position will involve 
day-to-day administrative project management and may provide scientific direction for research projects 
of considerable scope and complexity to technicians in the laboratory. 
Position Key Accountabilities:<ul><li>
Provides coordination between lab members, facilities, and supplies in support of research project desired 
outcomes, budgets, and timeliness.</li><li>
Assists in the preparation of progress reports and grant proposals to both private foundations and 
governmental agencies working closely with the PI.</li><li>
Attends research planning meetings to prepare budget drafts for departmental leadership approval.</li><li>
Maintains confidential records of collected data, ensures accuracy and integrity of data.</li><li>
Provides work administrative direction and guidance to research and/or administrative staff personnel being the bridge between the PI and human resources personnel.</li><li>
Other duties as needed.</li></ul> 
Certification/Skills:<ul><li>
Excellent communication skills both written and verbal.</li><li>
Working knowledge of MS Office.</li><li>
Certification from the Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Research Administrators Certification Council (RACC), Certified IRB Professional (CIP) or, Regulatory Affairs Certification (RAC), preferred.</li><li>
Depending on clinical trial, if nursing type duties are required, an RN license issued by the state of Texas is required.</li></ul>
Minimum Education:<ul><li>
Bachelor&rsquo;s degree in a related field or relevant experience in lieu of education.</li></ul>
Minimum Experience:<ul><li>
Five (5) years of relevant experience. May substitute required experience with equivalent years of education beyond the minimum education requirement.</li></ul>
Preferred:
Mosquito experience and molecular biology.
Physical Requirements:
Exerts up to 20 pounds of force occasionally and/or up to 10 pounds frequently and/or a negligible amount constantly to move objects. 
This position may include work involving potentially hazardous chemical, biological or radioactive agents.
Security Sensitive:
This position is a security-sensitive position pursuant to Texas Education Code &sect;51.215 and Texas Government Code &sect;411.094. To the extent that a position requires the holder to research, work on, or have access to critical infrastructure as defined in Texas Business and Commerce Code &sect;117.001(2), the ability to maintain the security or integrity of the infrastructure is a minimum qualification to be hired for and to continue to be employed in that position. Personnel in such positions, and similarly situated state contractors, will be routinely reviewed to determine whether things such as criminal history or continuous connections to the government or political apparatus of a foreign adversary might prevent the applicant, employee, or contractor from being able to maintain the security or integrity of the infrastructure. A foreign adversary is a nation listed in 15 C.F.R. &sect;791.4.
Residency Requirement:
Employees must permanently reside and work in the State of Texas.</div>

Research Coordinator III - School of Public Health

Evolution Research Group

<div>Job Title: FT Contract Clinical Research Associate (CRA) needed for Texas; ideal candidate will live in the state of Texas.
This is a FT 6 month+ contract, up to 40 hours per week for the first 3-6 months, then hours will vary based on study.
 Post-operative pain experience required
www.lotuscr.com 
Location: Remote
Job Description:
The Clinical Research Associate conducts site monitoring responsibilities for Clinical trials, according to Standard Operating Procedures, ICH guidelines, and GCP. This is a FT contract role, hours to vary after study is completed.
Essential Duties and Responsibilities:<ul><li>
Manage and monitor site activities for assigned clinical studies, working individually or co-monitoring with other Clinical Research Associates (CRAs).</li><li>
Monitoring activities will include but not be limited to site qualification, site initiation, interim monitoring, and close-out visits.</li><li>
During monitoring visits, the CRA ensures compliance with the protocol and applicable Company or Sponsor Standard Operating Procedures (SOPs), FDA regulations, and ICH-GCP guidelines.</li><li>
Perform site evaluation visits of potential investigators. Evaluate the capability of the site to successfully manage and conduct the clinical study.</li><li>
Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the case report forms, monitoring activities and study close-out activities.</li><li>
Assist in resolving any issues to ensure compliance with site file audits.</li><li>
Direct communication with investigational sites on visit planning, query resolution, action item resolution, and any other activities to support site management.</li><li>
Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Perform investigational product inventory. Ensure return of unused materials to designated location or verify destruction as required.</li><li>
Serve as primary contact with the site; coordinate all correspondence; ensure timely transmission of clinical data with the study site.</li><li>
Perform study close-out visits per the study specific Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.</li><li>
Ensure internal and study-related trainings are completed per Lotus and/or study timelines.</li><li>
Pre and post visit follow up include compliance to timelines indicated in the Monitoring Plan (MP) for Confirmation Letters, Follow up Letters and Monitoring Visit Reports (MVR).</li></ul>
Education and/or Experience:<ul><li>
Ability and willingness to travel up to 75% of the time (land and air).</li><li>
College degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).</li><li>
In lieu of the university /college degree or certification requirement, a minimum of 5 years of relevant clinical research experience in health care, pharmaceutical, or CRO settings may be considered and minimum of 2 years field monitoring experience as a CRA.</li><li>
Phase I experience preferred</li><li>
Preferred therapeutic areas: Substance Abuse, MAD/SAD, Hepatic, Impairment, Chronic Pain and Bipolar/Depression.</li><li>
Valid Driver&rsquo;s License.</li><li>
Legally authorized to work in the US.</li></ul>
Skills and Abilities:<ul><li>
Proficient knowledge of the drug development process, ICH guidelines, GCP, and the clinical trial process.</li><li>
Experience using electronic CRF platforms and processes.</li><li>
Exceptional attention to detail.</li><li>
Ability to interact effectively within and across team environments.</li><li>
Excellent organizational skills.</li><li>
Proficient computer skills with good working knowledge of a range of standard computer software required (e.g., email, document, spreadsheet, and presentation software).</li></ul></div>

CRO-Contract Clinical Research Associate (CRA)-Texas (TX)

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