ACDM SENIOR CLINICAL RESEARCH NURSE - Cardiology Clinical Trials
The Methodist Research Institute - Houston, TX

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The Senior Clinical Research Nurse manages multiple projects at different stages of the clinical research process, (Phase I-Phase 4). Implements research protocols, including screening and enrolling subjects, obtaining blood and other specimens for tests. Administering medications and maintaining pertinent patient records. Obtains, records, validates and interprets data to achieve the goals of the research project. Serves as a liaison between physicians, patients, staff and sponsors.

DUTIES AND RESPONSIBILITIES

' Assumes responsibility for IRB and regulatory document submissions, ensuring compliance with local and federal regulatory standards as appropriate. Follow 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.

' Oversees and collaborates in development of study tools including source documents, 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; compiles enrollment statistics and prepares reports.

' 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 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.

' Conducts periodic quality assurance reviews of on-going studies; maintains productive working relationship with study monitors.

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

' May supervise efforts of clinical research team members assigned to clinical research studies. Precepts new clinical research staff in clinical setting.

' Assesses ongoing resource requirements for studies and makes recommendations as appropriate.

' May collaborate in development and writing of protocols and consent forms, as appropriate.

' Maintains accountability for ongoing professional growth and development. Participates in institutional committees, forums and educational programs as an integral part of the position.

EDUCATION REQUIREMENTS

Bachelors Degree required; Master's degree preferred

EXPERIENCE REQUIREMENTS

Five plus years of research experience required.

CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED

Current Registered Nurse Licensure in the State of Texas

CCRC or CCRP required

SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

' Phase 1-4 research experience

' Supervisory experience

' Highly effective communication skills

' Highly effective time management skills

' Ability to understand and implement protocols

' Experience with computer database management

' Microsoft Office skills

' Strong interpersonal skills

PHYSICAL REQUIREMENTS

' Extended periods of walking and standing may be required

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

' Activity Checklist attached (see final page)

WORKING ENVIRONMENT

Patient care unit conditions

Operating room conditions

Universal precautions required

Significant potential for exposure to Latex

DUTIES AND RESPONSIBILITIES

' Assumes responsibility for IRB and regulatory document submissions, ensuring compliance with local and federal regulatory standards as appropriate. Follow 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.

' Oversees and collaborates in development of study tools including source documents, 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; compiles enrollment statistics and prepares reports.

' 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 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.

' Conducts periodic quality assurance reviews of on-going studies; maintains productive working relationship with study monitors.

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

' May supervise efforts of clinical research team members assigned to clinical research studies. Precepts new clinical research staff in clinical setting.

' Assesses ongoing resource requirements for studies and makes recommendations as appropriate.

' May collaborate in development and writing of protocols and consent forms, as appropriate.

' Maintains accountability for ongoing professional growth and development. Participates in institutional committees, forums and educational programs as an integral part of the position."/>
Bachelors Degree required; Master's degree preferred

EXPERIENCE REQUIREMENTS

Five plus years of research experience required.

CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED

Current Registered Nurse Licensure in the State of Texas

CCRC or CCRP required

SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

' Phase 1-4 research experience

' Supervisory experience

' Highly effective communication skills

' Highly effective time management skills

' Ability to understand and implement protocols

' Experience with computer database management

' Microsoft Office skills

' Strong interpersonal skills

PHYSICAL REQUIREMENTS

' Extended periods of walking and standing may be required

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

' Activity Checklist attached (see final page)

WORKING ENVIRONMENT

Patient care unit conditions

Operating room conditions

Universal precautions required

Significant potential for exposure to Latex"/>
If you are experiencing difficulties, please call 1-877-560-5656. If calling from outside the United States or Canada, call 402-419-5617 (or) Please e-mail

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