Houston Methodist Academic Institute
Research Coordinator II - Transplant
Houston Methodist Academic Institute, Houston, Texas, United States, 77246
At Houston Methodist, the Research Coordinator II Transplant position is responsible for coordinating and gathering patient data for clinical research activities via methods specified in the study protocol and performs general administrative duties supporting the study.
PEOPLE ESSENTIAL FUNCTIONSUnder direction of PI may draft various communications with Sponsor and/or regulatory documents to be sent to the Sponsor.Identifies and recruits clinical research subjects and monitors enrollment goals; mentors research coordinators regarding enrollment and recruitment.May assist PI in obtaining Informed Consent from study participant and documents appropriately.Develops and maintains productive working relationship with the study monitor; attends and participates in campus coordinator workshops
SERVICE ESSENTIAL FUNCTIONSSchedules, coordinates, and participates in the pre-site visit and site initiation visits;coordinates study initiation.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.
QUALITY/SAFETY ESSENTIAL FUNCTIONSMay attend and participate in the Investigator meeting. Prepares IRB documents under the direction of the PI and assists with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval.Completes an initial patient assessment utilizing interview and observation; assists in identifying the patient at risk, psychologically, and physiologically. If appropriately trained and tested for competency, obtains Vital Signs and performs phlebotomy; monitors participants' labs and notifies the PI of laboratory findings.Maintains and monitors source documentation and appropriate forms as per protocol for quality and accuracy, including participant records; assists with the quality assurance process.Reconciles study drug accountability; maintains temperature and QC logs per protocol compliance.Follows all safety rules while on the job. Reports accidents promptly and corrects minor safety hazards. Completes all hospital required and job-related in-services and applies the information as needed.
FINANCE ESSENTIAL FUNCTIONSAssists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment; maintains regulatory standards. Manage study finances and resources needed to conduct a clinical study.Assists with the budget development; may monitor ledgers.
Adheres to internal controls established for department.
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
Assists PI and/or research nurse coordinator in the planning and design of source documents for protocol.Assists in developing procedures for laboratory collection and storage. May conduct in-service to floor nurses/physicians; assists in precepting new clinical research staff and educating other research staff regarding scientific aspects of studies.
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.EDUCATIONBachelor's degree in a health science field required.
WORK EXPERIENCEGreater than or equal to 2 years' experience coordinating clinical research
LICENSES AND CERTIFICATIONS - REQUIREDBLS - Basic Life Support (AHA)
LICENSES AND CERTIFICATIONS - PREFERREDCCRC - Certified Clinical Research Coordinator (ACRP)
ORCCRP - Certified Clinical Research Professional (SOCRA)
KNOWLEDGE, SKILLS, AND ABILITIESDemonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluationsSufficient 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 securityAbility 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 principlesSUPPLEMENTAL REQUIREMENTSWORK ATTIREUniform NoScrubs YesBusiness professional NoOther (department approved) YesON-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 NoMay require travel outside Houston Metropolitan area NoCompany Profile:Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. 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&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 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 more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.Houston Methodist is an equal opportunity employer inclusive of women, minorities, disabled persons and veterans.Equal Employment OpportunityHouston 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.
PEOPLE ESSENTIAL FUNCTIONSUnder direction of PI may draft various communications with Sponsor and/or regulatory documents to be sent to the Sponsor.Identifies and recruits clinical research subjects and monitors enrollment goals; mentors research coordinators regarding enrollment and recruitment.May assist PI in obtaining Informed Consent from study participant and documents appropriately.Develops and maintains productive working relationship with the study monitor; attends and participates in campus coordinator workshops
SERVICE ESSENTIAL FUNCTIONSSchedules, coordinates, and participates in the pre-site visit and site initiation visits;coordinates study initiation.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.
QUALITY/SAFETY ESSENTIAL FUNCTIONSMay attend and participate in the Investigator meeting. Prepares IRB documents under the direction of the PI and assists with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval.Completes an initial patient assessment utilizing interview and observation; assists in identifying the patient at risk, psychologically, and physiologically. If appropriately trained and tested for competency, obtains Vital Signs and performs phlebotomy; monitors participants' labs and notifies the PI of laboratory findings.Maintains and monitors source documentation and appropriate forms as per protocol for quality and accuracy, including participant records; assists with the quality assurance process.Reconciles study drug accountability; maintains temperature and QC logs per protocol compliance.Follows all safety rules while on the job. Reports accidents promptly and corrects minor safety hazards. Completes all hospital required and job-related in-services and applies the information as needed.
FINANCE ESSENTIAL FUNCTIONSAssists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment; maintains regulatory standards. Manage study finances and resources needed to conduct a clinical study.Assists with the budget development; may monitor ledgers.
Adheres to internal controls established for department.
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
Assists PI and/or research nurse coordinator in the planning and design of source documents for protocol.Assists in developing procedures for laboratory collection and storage. May conduct in-service to floor nurses/physicians; assists in precepting new clinical research staff and educating other research staff regarding scientific aspects of studies.
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.EDUCATIONBachelor's degree in a health science field required.
WORK EXPERIENCEGreater than or equal to 2 years' experience coordinating clinical research
LICENSES AND CERTIFICATIONS - REQUIREDBLS - Basic Life Support (AHA)
LICENSES AND CERTIFICATIONS - PREFERREDCCRC - Certified Clinical Research Coordinator (ACRP)
ORCCRP - Certified Clinical Research Professional (SOCRA)
KNOWLEDGE, SKILLS, AND ABILITIESDemonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluationsSufficient 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 securityAbility 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 principlesSUPPLEMENTAL REQUIREMENTSWORK ATTIREUniform NoScrubs YesBusiness professional NoOther (department approved) YesON-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 NoMay require travel outside Houston Metropolitan area NoCompany Profile:Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. 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&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 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 more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.Houston Methodist is an equal opportunity employer inclusive of women, minorities, disabled persons and veterans.Equal Employment OpportunityHouston 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.