ACDM CLINICAL RESEARCH NURSE--CARDIOLOGY CLINICAL TRIALS
The Methodist Research Institute - Houston, TX

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JOB SUMMARY

With minimal supervision, manages complex research projects that may involve sites and/or the supervision of research activities. Implements research protocols, including screening and enrolling subjects, obtaining blood and other specimens for tests. Administering medications and maintaining pertinent patient records. Obtain, record, validate and interpret data to achieve the goals of the research project. Serves as a liaison between physicians, patients, staff and sponsors.

PATIENT AGE GROUP SERVED

Direct patient care.

DUTIES AND RESPONSIBILITIES

' With minimal supervision, demonstrates ability to manage multiple projects at different stages of the clinical research process (Phase 1-Phase 4)

' With minimal supervision, prepares IRB and regulatory documents for submission assuring compliance with local and federal regulatory standards as appropriate. Follows ICH/GCP guidelines.

' Coordinates pre-site and site initiation visits; trains hospital and clinic nurses/physicians on scientific aspects and protocol requirements of research studies. Attends off-site investigator meetings.

' Assists with development of study tools including sources documents and eligibility checklists and criteria cards.

' Assists with budget development and institutional account reconciliation of protocol-driven ancillary procedures and tests.

' Identifies, recruits, and consents clinical research subjects for participation in approved clinical trials; monitors enrollment goals and modifies enrollment strategies, as necessary.

' Provides comprehensive nursing assessments to develop, coordinate, implement and evaluate activities associated with all phases of clinical research projects. Monitors safety of all research subjects and reports adverse events.

' Performs nursing functions independently and in collaboration with Principal Investigator as approved by Hospital administration for the conduct of clinical research.

' Provides patient education regarding disease process and involves patient and family in decision-making processes.

' Collects and enters study data on manual or electronic case report forms according to prescribed standards.

' Collects, processes and ships protocol-required lab specimens; maintains supply and equipment inventory; maintains appropriate laboratory certification.

' Maintains inventory and accountability of investigational products and supplies; maintains appropriate logs.

' Monitors source documents and case report forms for completion and accuracy; assists with quality assurance processes.

' Performs study closeout procedures including post-study documentation, return of study materials to the sponsor and data archiving.

' May precept new clinical research staff in clinical setting.

' Maintains accountability for ongoing professional growth and development. Participates in unit activities.

' Performs other duties as assigned.

EDUCATION REQUIREMENTS

Associate Degree in Nursing required

Bachelors Degree preferred

EXPERIENCE REQUIREMENTS

Minimum of 1 to 5 years of experience required

CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED

Current Registered Nurse Licensure in the State of Texas

SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

Supervisory experience required.

Requires highly effective communication skills.

Requires highly effective time management skills

Requires ability to understand and implement protocols.

Requires experience with computer database management.

Requires Microsoft Office skills.Requires strong interpersonal skills.

PHYSICAL REQUIREMENTS

Extended periods of walking and standing may be required.

Lifting, pushing or pulling required (minimum 50 lbs.)

WORKING ENVIRONMENT

Patient care unit conditions

With minimal supervision, manages complex research projects that may involve sites and/or the supervision of research activities. Implements research protocols, including screening and enrolling subjects, obtaining blood and other specimens for tests. Administering medications and maintaining pertinent patient records. Obtain, record, validate and interpret data to achieve the goals of the research project. Serves as a liaison between physicians, patients, staff and sponsors.

PATIENT AGE GROUP SERVED

Direct patient care.

DUTIES AND RESPONSIBILITIES

' With minimal supervision, demonstrates ability to manage multiple projects at different stages of the clinical research process (Phase 1-Phase 4)

' With minimal supervision, prepares IRB and regulatory documents for submission assuring compliance with local and federal regulatory standards as appropriate. Follows ICH/GCP guidelines.

' Coordinates pre-site and site initiation visits; trains hospital and clinic nurses/physicians on scientific aspects and protocol requirements of research studies. Attends off-site investigator meetings.

' Assists with development of study tools including sources documents and eligibility checklists and criteria cards.

' Assists with budget development and institutional account reconciliation of protocol-driven ancillary procedures and tests.

' Identifies, recruits, and consents clinical research subjects for participation in approved clinical trials; monitors enrollment goals and modifies enrollment strategies, as necessary.

' Provides comprehensive nursing assessments to develop, coordinate, implement and evaluate activities associated with all phases of clinical research projects. Monitors safety of all research subjects and reports adverse events.

' Performs nursing functions independently and in collaboration with Principal Investigator as approved by Hospital administration for the conduct of clinical research.

' Provides patient education regarding disease process and involves patient and family in decision-making processes.

' Collects and enters study data on manual or electronic case report forms according to prescribed standards.

' Collects, processes and ships protocol-required lab specimens; maintains supply and equipment inventory; maintains appropriate laboratory certification.

' Maintains inventory and accountability of investigational products and supplies; maintains appropriate logs.

' Monitors source documents and case report forms for completion and accuracy; assists with quality assurance processes.

' Performs study closeout procedures including post-study documentation, return of study materials to the sponsor and data archiving.

' May precept new clinical research staff in clinical setting.

' Maintains accountability for ongoing professional growth and development. Participates in unit activities.

' Performs other duties as assigned."/>
Associate Degree in Nursing required

Bachelors Degree preferred

EXPERIENCE REQUIREMENTS

Minimum of 1 to 5 years of experience required

CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED

Current Registered Nurse Licensure in the State of Texas

SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

Supervisory experience required.

Requires highly effective communication skills.

Requires highly effective time management skills

Requires ability to understand and implement protocols.

Requires experience with computer database management.

Requires Microsoft Office skills.Requires strong interpersonal skills.

PHYSICAL REQUIREMENTS

Extended periods of walking and standing may be required.

Lifting, pushing or pulling required (minimum 50 lbs.)

WORKING ENVIRONMENT

Patient care unit conditions"/>
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