Clinical Trial Research Nurse I Jobs

1+ years of Nursing experience

Utilize nursing assessment skills to observe participant general well-being and potential adverse events.

Active RN or LPN license in the state of Wisconsin

Enroll patients into clinical trials through the Informed Consent (ICF) process: educating, explaining and informing participants of study procedures.

Document adverse events and take appropriate action as needed.

Perform study-related activities such as vital signs, ECGs, and venipuncture.

Completes nursing history and initiates patient education.

Demonstrates competence in performing critical skills to include appropriate delivery of care according to the age-specific needs of the population served.

$5k Sign-on Bonus for Experienced RNs

Correlates patient history and support systems across continuum of care.

Collaborates with interdisciplinary teams making recommendations to facilitate patient care.

Implements plan of care appropriate to diagnosis and patient needs. Evaluates outcomes.

Ability to work in a fast paced / dynamic team environment and possess time management skills to meet schedules.

Line management experience. Typically has multiple years’ experience managing other people leaders (with indirect reports).

Experience on governance committees and management teams for CROs or other vendors.

Periodic analysis of data and reporting to management and regulatory representatives.

Manages people managers; recruits, hires, mentors, and manages direct reports as required and supports their professional development.

The job is in-person at the Boca Raton office, remote work as necessary.

Communicates with Sponsored Programs Administration to ensure proper management of charges and billing.

Recruits, interviews and obtains informed consent from prospective subjects for entrance into clinical trials and studies.

Coordinators appropriate laboratory tests and other procedures for subjects participating in studies; including drawing blood or collection of other samples.

Coordinates with Investigational Pharmacy for subjects to receive required drugs.

Coordinates and submits IRB protocols, reports, revisions, updates, approvals.

Records appropriate clinical and laboratory data on forms provided by the principal investigator(s), federal government, and/or industry sponsors.

Updates and maintains site staff skills, training and knowledge of current best nursing practices and topics related to clinical research

Orients research subjects to the study including the purpose of the study, procedures and protocol requirements such as timeline for visits

Maintains source documentation based on protocol requirements that adhere to Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) documentation principles

Assists in providing training to new investigator site staff members on study-specific topics and requirement

Maintains adherence to investigator site staff training requirements by auditing and maintaining training records

3 years relevant experience Req Or

Hiring Range: $85,000 - $97,000 (Commensurate with education and experience)

Perform other duties as assigned.

The University of Maryland, Baltimore (UMB), Center for Vaccine Development and Global Health (CVD)

Proficient in Microsoft Office Word and basic knowledge in data entry (i.e. Excel).

Position requires an individual with: Excellent oral and written communication skills.

Detail-oriented and excellent organizational skills.

Maintains licensure/certification as appropriate to clinical profession.

Associates Degree plus RN required.

Cook Children's is an EOE/AA, Minority/Female/Disability/Veteran employer

May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.

Participates in required training and education programs.

Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution.

Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.

Coordinates research projects at an institutional or departmental level.

Communicates project status and improvement areas with leadership in a timely manner.

This position has the following minimum qualification requirements: nurse education, license and specialized experience.

Applicants must meet all qualification requirements by the closing date of this announcement.

U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.

Males born after December 31, 1959 must be registered with the Selective Service.

This position is designated as Tier-1 Emergency Essential. See Additional Information section for specific details on this designation

This position may require the following work shifts: nights, rotational, holidays, weekends.

Facilitating verbal directions from the Principal Investigator (PI) to study participants and/or clinical study staff and ensuring appropriate follow-through.

Communicating the progress of study conduct to PI, CSM, and members of the clinical study team.

Reinforcing rules and regulations with study participants, managing participant complaints, and maintaining participant satisfaction.

Maintaining compliant, clear and accurate study charts and documentation of all AEs reported and Concomitant Medication usage throughout the study.

Providing leadership to the clinical study team.

Providing administrative and operational support to ensure successful conduct of study protocols.

Recognizes and implements legal and ethical responsibilities and duties of registered nurses;

Seeks supervision and guidance in developing nursing skills, in performing procedures not yet mastered, and when functioning in unfamiliar situations.

Must possess and maintain the following certification(s) during employment:

For clinical specialty areas, must possess and maintain the following certification(s) during employment:

Utilize educational resources available for promoting self-learning;

Ability to perform physical skills required to deliver patient care;

Work with accounting/finance to help establish budgets, track invoices, approve vendor activity and assists with budget reconciliation

Train investigative site staff on protocol responsibilities, Investigational Product accountability and study documentation

Excellent written and oral communication and presentation skills

The ability to manage multiple priorities, while maintaining attention to detail is critical.

Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms)

Specific responsibilities include but are not limited to:

Experience with and knowledge of judicial processes in the California Court System.

Preferred Knowledge, Skills, and Ability:

Recent experience conducting civil, administrative, or criminal investigations in the State of California.

Experience writing reports, evaluating information, and making recommendations.

Experience reading and interpreting RAP sheets and/or investigative data.

Experience using software, databases, or law enforcement systems to conduct investigations.

Document remote monitoring activities on appropriate report template.

Collect and review essential documents for accuracy and completeness (1572, CVs, medical licenses, etc.) as needed to assist Study Start-up Manager.

Maintain productivity while working remotely.

College degree preferred or equivalent work experience.

Minimum of two years relevant work experience in clinical research operations, ophthalmology highly preferred

Experience working with EDC systems

If applicable, department specific clinical certification and/or experience may be required

Beaumont offers a comprehensive benefits package to meet your financial, health and life-work balance goals.

Current phlebotomy skills highly preferred

Prior medical/surgical clinical experience required

BLS Healthcare Provider Certification required

Excellent verbal and written skills and organizational skills required

Will this position accept substitution in lieu of education or experience?

Minimum Years of Experience Required

Med-MIRM-Dr Chandan Sen Group - Pennsylvania-Pittsburgh - (23003933)

Bachelor’s degree in healthcare/science related field. However, upon evaluation, equivalent related experience and/or education may be substituted for the degree requirement.

Clinical research study processes, study design and/or protocol management.

Receives guidance and mentoring to manage complex issues.

Training and conflict resolution skills.

Manage multiple deadlines and priorities while ensuring quality and timeliness.

Work effectively and efficiently in a remote environment.

Detail-oriented and strong time-management skills

Bachelor’s Degree and 1-2 years of relevant experience in research, healthcare, data, or other related fields (Internship experience may be sufficient)

Knowledge of research methods, data analysis, quality metrics

Language skills is a plus

Biological, clinical, or medical experience is a plus

Drive change through informing R&C processes for profile creation from EM no match queues, starting with Clinical Trial data

Must meet Education Requirements (See Qualification section below).

If you are relying on your education to meet qualification requirements:

Applicants must meet all qualification requirements by the closing date of this announcement.

This position has an education requirement. Unofficial Transcripts required.

You qualify at the GS-07 level if you meet one of the following qualification requirements:

Protects research participant data in accordance with regulatory requirements.