Clinical Research Nurse RN

Job Summary * (In three or four sentences summarize the job's purpose and primary focus.)
Under the direction of the Clinical Trials Manager and the Clinical Trials Site Supervisor, assists in ensuring the integrity and quality of the clinical trial(s) are maintained and conducted in accordance with federal, state, and local regulations, Institutional Review Board (IRB). With the direction of the Principal Investigator (PI), this position coordinates research activities as outlined in the Major Responsibilities below. Serves as the first point of contact by telephone and mail with the study participants for recruitment, scheduling of visits, protocol adherence and retention. Travels to other medical office buildings. This position is also responsible for protecting the health, safety, and welfare of clinical trial participants.
Major Responsibilities/Essential Functions * (In order of importance, list primary job duties this position is responsible for achieving. Each statement should relate to an end result or objective.)
Study Implementation
* Utilizes nursing skills to coordinate research-related activities (e.g., scheduling study visits, assisting with nursing assessments of participants, adverse events, and data collection including laboratory and diagnostic studies).
* Manages visits with the sponsoring companies and assists in the initiation of clinical trials.
* With direction, participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development in the conduct of clinical trials.
* With supervision and direction by PI and/or designee, plan recruitment procedures for potential participants.
* Assist in the determination of eligibility of candidates for study participation.
* Assist in the enrollment of subjects into the trial (screening, randomization, and data collection) and any study-related procedures as required by the protocol.
* Participate in the ongoing informed consent process with the PI to ensure the research participants and their families have their questions answered.
* Assist with the study completion, resolution of data queries, data lock, study closeout, and archiving of study files.
* Provide regulatory support to ensure proper maintenance and storage of critical documents required to be maintained and provided to the sponsor during the conduct of the trial.
* Support the effective financial management of the clinical trial.
* Perform nursing procedures required in the protocol in accordance with the scope of practice and the Georgia State Board of Nursing Standards.
* Coordinate and perform packaging and shipping of protocol specimens to the sponsor lab in accordance with IATA/DOT regulations and sponsor shipping guidelines, if applicable.
* Serves as liaison between the site, PI, study participant and study sponsor for assistance with questions, adverse events and communicating information.
* Report all protocol violations/deviations and adverse events to the PI in a timely manner to ensure the health, safety and welfare of the participants.
* Performs accurate data collection, management and reporting including timely communication of study-related changes and serious adverse events with the sponsor and Kaiser Permanente's Institutional Review Board (IRB).
* With supervision, utilize and document the nursing procedures to plan, deliver, and evaluate research care for non-complex medical conditions and, with appropriate assistance, for complex medical conditions.
* Performs timely completion of data entry on the case report forms (CRF) and query response.
* Accurately and completely record information in the source documents in a timely manner.
Leadership and Communication
* With guidance from the PI, communicates with and educates the research participant about study activities and requirements as needed.
* When applicable and with supervision, coordinate IRB communications (e.g., new protocols, amendments, modifications, continuing review applications, protocol violations, and adverse events) in accordance with institutional and departmental policies and procedures.
Education and Training
* With direction, participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development as a clinical trials nurse participating in the conduct of clinical trials. Work with an assigned mentor on a regular basis for training and resource questions.
* Participate as a member of the clinical trials team and attend meetings, as requested.
* Attend meetings for protocol training initiated by KP and the Sponsor, as requested.
Compliance
* Support and comply with the Principles of Responsibility.
* With guidance, assist with ensuring compliance with KPGA IRB approved protocols.
* Adhere to Guideline for Good Clinical Practice (GCP), federal, state, and local regulations, and policies and procedures.
* Assists with any internal/external compliance monitoring and/or audits and inspections to protect research participants, assure operational effectiveness of the program and to reduce risks to the organization.
* Ensures the clinical trials records and files are maintained in an audit readiness manner and are in compliance with federal and FDA regulations, guidelines to Good Clinical Practice (GCP) .
* Assists with the maintenance of systems and resources for the effective communication and submission of required documentation to the IRB.
* Adhere to departmental policies and procedures to ensure confidentiality, privacy and security of clinical research interactions and participant information, and responsible use of operational research databases in compliance with KP policies.
* Adhere to departmental policies and procedures to support high-quality implementation and conduct of trials, and assure maintenance of research activities and documentation in compliance with the protocols and policies and procedures.
Quality improvement
* With direction, perform routine quality control activities and assist with quality improvement initiatives.
General
* May perform other duties as assigned by appropriate management.
* Travel to the Regional office and other medical office buildings required for education/training, participant recruitment, participant study visits, and meetings.

About Aerotek:

Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .

Aerotek is acting as an Employment Agency in relation to this vacancy.