Job Description

GENERAL SUMMARY:

Essential in managing clinical research studies, requiring adaptability to various medical areas for effective participant evaluation and support of diverse protocols. Responsible forensurinjg the safety, rights, and well-being of participants participating in clinical research studies. This role integrates clinical expertise with regulatory compliance to support ethically conducted research while maintaining the highest standards of patient-centered care.

PRINCIPAL JOB FUNCTIONS:

*Commits to the mission, vision, beliefs and consistently demonstrates our core values.

Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements.

Assists with the preparation of Institutional Review Board (IRB) applications including protocol and informed consents and obtaining approval to conduct the study.

Maintains appropriate correspondence with the IRB, including adverse events, protocol deviations, annual renewals, and protocol amendments.

Designs and develops accurate source materials and workflow procedures in accordance to study protocols and standard operating procedures.

Schedule and conduct interviews along with an investigator for potential participants, obtain informed consent, and enroll subjects to the research study.

Performs medical tests, including, but not limited to, vital signs, imaging studies, electrocardiograms, and phlebotomy.

Disperses and administers investigational medications and performs participant assessments during and after clinic visits to determine presence of side effects; notifies investigator of critical findings/issues.

Provides participant education and medical information to ensure understanding of proper medication dosage, administration, and management of their disease.

Learn and troubleshoot medical devices used in studies, train medical center and clinic staff on device usage, and ensure safety.

Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities.

Provides accurate and timely data collection to ensure data quality as required by study protocols and Standard Operating Procedures. This includes all documentation, data entry, and reporting in both sponsor and EMR databases.

Collaborate with multidisciplinary teams (including but not limited to: surgeons, surgery staff, procedure/diagnostic/clinic schedulers, cardiology , radiology and bedside and clinic staff, etc.) to support study workflows, scheduling of procedures, and managing participant appointments.

Ensures appropriate credentialing and training of the entire Bryan Health team.

Perform rapid eligibility assessment and enrollment for acute care emergency research studies. Managing complex protocols in critical care settings, coordinating with intensivist, bedside nursing and pharmacists.

Ensures timely monitoring of post-operative outcomes and adverse events documentation.

Ensures maintenance of regulatory documents in accordance with Bryan Health standard operating procedures and applicable regulations.

Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsors, monitors, investigators, and study participants.

Ensures compliance with research protocols, by providing ongoing quality control audits, maintaining investigational product accountability.

Participates with the investigator and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance.

Adhere to HIPAA requirements and maintain confidentiality.

Develop additional clinical skills to meet the needs of individual studies.

Maintains professional growth and development through seminars, workshops, and professional affiliations to keep abreast of latest trends in field of expertise.

Participates in meetings, committees and department projects as assigned.

Performs other related projects and duties as assigned.

(Essential Job functions are marked with an asterisk "*".

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire.

Knowledge of computer hardware equipment and software applications relevant to work functions.

Knowledge of clinical study design concepts, clinical research ethics, informed consent processes, and applicable regulatory requirements for conducting clinical research trials.Knowledge of general nursing theory, regulations, and practices in giving and evaluating patient care.Ability to work a flexible schedule, including evenings, weekends, and holidays, as needed per study protocol guidelines.

Knowledge of medications and their possible effects on participants. .

Knowledge of medical terminology, drug calculations skills, clinical medicine, clinical trials and GCP concepts. and coding.

Knowledge of sterile field boundaries and surgery workflows.

Attends investigator meetings and national conferences as required to maintain clinical research competency and protocol knowledge. Ability to quickly learn and adapt to new therapeutic areas based on study-specific inclusion and exclusion criteria.

Ability to communicate effectively both verbally and in writing.

Ability to effectively organize and prioritize work projects and manage time.

Ability to incorporate diverse teaching strategies relating to documentation requirements to achieve quality management, clinical and operational goals.

Ability to facilitate change and manage projects through analysis, key end user engagement, and consensus building within an interdisciplinary environment.

Ability to assess, plan, implement and evaluate the clinical theoretical processes as they relate to participant care and technology.

Ability to engage independent critical thinking skills.

Ability to communicate effectively both verbally and in writing.

Ability to perform crucial conversations with desired outcomes.

Ability to establish and maintain effective working relationships with all levels of personnel and medical staff.

Ability to problem solve and engage independent critical thinking skills.

Ability to maintain confidentiality relevant to sensitive information.

Ability to prioritize work demands and work with minimal supervision.

Ability to work independently, take direction and work collaboratively with others.

Ability to network and develop effective working relationships with all co-workers, clinical and non-clinical colleagues.

Ability to maintain regular and punctual attendance.

EDUCATION AND EXPERIENCE:

Current Registered Nurse licensure from the State of Nebraska or approved compact state of residence as defined by the Nebraska Nurse Practice Act. Bachelor's degree preferred. Minimum two (2) years of clinical experience required. Experience in clinical research, study coordination, data management and study development is preferred. Clinical Research Nurses certification required within two (2) years of eligibility in alignment with professional standards and regulatory requirements.

OTHER CREDENTIALS / CERTIFICATIONS:

Basic Life Support (BLS) certification required. Bryan Health recognizes American Heart Association (for healthcare professionals), American Red Cross (for healthcare professionals) and the Military Training Network. Advanced Cardiac Life Support preferred.

PHYSICAL REQUIREMENTS:

(Physical Requirements are based on federal criteria and assigned by Human Resources upon review of the Principal Job Functions.)

(DOT) - Characterized as medium work requiring exertion of 35 to 50 pounds of force occasionally, and/or up to 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects including the human body.

Job Tags

Similar Jobs