At Houston Methodist, the Research Coordinator II 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. Under minimal supervision, this position is responsible for ensuring accurate data collection, documentation, organization and safety of research participants, gathering patient data for clinical research activities via methods specified in the study protocol and performs general administrative duties supporting the study.

　　PEOPLE ESSENTIAL FUNCTIONS

　　Under the direction of the Principal Investigator (PI), drafts various communications with the Sponsor and/or regulatory documents to be sent to the Sponsor.

　　Identifies and recruits clinical research subjects and monitors enrollment goals.

　　May conduct in-services to floor nurses/physicians; assists in precepting new clinical

　　research staff and educating other research staff regarding scientific aspects of studies.

　　Teaches peers to critically think by verbally expressing rationale for decisions and follows up consistently. Uses peer-to-peer accountability towards improvement of department score for turnover/retention/employee engagement.

　　SERVICE ESSENTIAL FUNCTIONS

　　Participates in the Principal Investigator (PI) meetings.

　　Schedules, coordinates, and participates in the pre-site visit and site initiation visits; coordinates study initiation. Obtains Informed Consent from study participant and documents appropriately.

　　Obtains vital signs and performs phlebotomy per training and competence; monitors participants' labs and notifies the PI of laboratory findings.

　　QUALITY/SAFETY ESSENTIAL FUNCTIONS

　　Prepares Institutional Research Board (IRB) documents under the direction of the PI, assists with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval.

　　Maintains and monitors source documentation and appropriate forms as per protocol for quality and accuracy, including participant records; assists with the quality assurance process. Adheres to internal controls established for the department.

　　FINANCE ESSENTIAL FUNCTIONS

　　Assists with the budget development and Medicare coverage analysis.

　　Utilizes resources effectively and efficiently, demonstrating responsible financial stewardship. Manages own time effectively and prioritizes work to achieve maximum results in a timely manner.

　　GROWTH/INNOVATION ESSENTIAL FUNCTIONS

　　Assists PI and/or research nurse in the planning and design of source documents for protocol.

　　Assists in developing procedures for laboratory collection and storage.

　　Incorporates directions from other health care disciplines into clinical research protocols when reviewing patient eligibility; assists in eliciting relevant data from sources outside of the hospital.

　　Proactively manages own professional development and completes My Development Plan.

　　This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.

　　EDUCATION

　　Bachelor's degreeWORK EXPERIENCE

　　Four years of research experienceLICENSES AND CERTIFICATIONS - REQUIRED

　　N/ALICENSES AND CERTIFICATIONS - PREFERRED

　　CCRC - Certified Clinical Research Coordinator (ACRP) within 1 year or

　　CCRP - Certified Clinical Research Professional (SOCRA) within 1 year

　　KNOWLEDGE, SKILLS, AND ABILITIES

　　Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations

　　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

　　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

　　Ability to work independently

　　Capable of handling challenging/difficult situations

　　Demonstrates sound judgment and executes above average analytical skills

　　SUPPLEMENTAL REQUIREMENTS

　　WORK ATTIRE

　　Uniform No

　　Scrubs Yes

　　Business professional No

　　Other (department approved) Yes

　　ON-CALL*

　　*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.

　　On Call* NoTRAVEL**

　　Travel specifications may vary by department

　　May require travel within the Houston Metropolitan area No

　　May require travel outside Houston Metropolitan area No

　　Company Profile:

　　The Houston Methodist Academic Institute team science approach bridges the boundaries between medical specialties and research and development labs to advance the practice of medicine and population health. We innovate in health care delivery and technology by streamlining the path discoveries take into the clinic with inventive development and adoption practices. Our teams are also dedicated to training clinicians and researchers from around the world in translational medicine and advanced technology. Houston Methodist's primary academic affiliates are top-ranked Weill Cornell Medical College and the Weill Cornell Graduate School of Medical Sciences for faculty appointments and graduate programs offered on our Houston campus.

　　The Institute oversees 600,000 sq ft of dedicated space and the administrative and operational infrastructure for basic and applied research and clinical trials, including more than 20 advanced tech core facilities, extramural funding management, regulatory and legal strategy and compliance, and product development and commercialization. This infrastructure is fully integrated with our hospital systems and supports more than 50,000 learners, 700 faculty, 2000 credentialed researchers, 6,000 research projects and clinical trials that creates innovative breakthroughs in human disease and the practice of medicine every day.

　　Houston Methodist is an equal opportunity employer inclusive of women, minorities, disabled persons and veterans.

　　Equal Employment Opportunity

　　Houston Methodist is an Equal Opportunity Employer.

　　Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor – priority referral Protected Veterans requested.

　　Houston Methodist is an Equal Opportunity Employer.

　　Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor – priority referral Protected Veterans requested.