Clinical Trials Nurse Supervisor - Full-time / Part-time

Supervises the Clinical Trials staff responsible for implementing clinical research projects. Adheres to all Center for Clinical and Outcomes Research (CCOR) policies and procedures and assures adherence to federal and local regulations governing research and good clinical practices. Travels to other medical office buildings.

Duties:
Provides first level supervision of clinical trials research staff in all clinical disciplines.

Ensures clinical trials staff practices within their defined scope based upon their role, certification and licensure guidelines.

Assists clinical trial leadership in establishing priorities to accomplish goals, managing and allocating resources, and tracking results.

Ensures research policies and procedures are implemented correctly or all research studies being performed by assigned staff. Serves as a consultant, advisor, mentor, and problem-solver for clinical trial staff.

Manages the distribution of work for the site.

Provides a timely assignment of resources to pre-study tasks and staffing of clinical trials.

Assists Clinical Trial Manager in the financial management and billing for all clinical trial processes and procedures.

Monitors the schedules of the clinical trials staff onsite.

Participates in the hiring process and the training of new staff, as well as assisting in conducting performance evaluations, counseling, disciplining and/or terminating staff in accordance
with company policies, procedures and standards.

Works with clinics, laboratories, pharmacies, hospitals, and other facilities, departments or staff to promote a positive working relationship and ensure clinical research protocols systematically support health operations.

Required attention to compliance. This is a big company push. They will responsibility for overbite on these. Monitoring Drug accountability. Potential for growth.

Fosters an environment of trust, compliance, open communication and professionalism.

Schedules, conducts and coordinates study participant visits and directs all activities related to the study visit including labs and clinical testing (ECGs).

Assists the PI in identifying and determining the eligibility of potential participants.

Enrolls and manages study patient follow-up to include: data collection, data entry, and documentation in the electronic medical record system.

Assist the PI in the ongoing informed consent process to ensure research participants and their families are knowledgeable about the clinical trials and have their questions answered.

Serves as Coordinator to provide appropriate coverage and to mentor/assist staff.

Assists with the study completion, resolution of data queries, data lock, study closeout, and archiving of study files.

Performs accurate data collection, management and reporting including timely communication of study related changes and serious adverse events with the sponsor and Institutional Review Board (IRB).

Ensures the clinical trial records and files are maintained in an audit readiness manner and are in compliance with federal and FDA regulations, guidelines to good clinical practice and policies and procedures.

Works with the sponsors to manage monitoring visits and to initiate studies.

Coordinate and perform packaging and shipping of protocol specimens to the sponsor lab in accordance with IATA/DOT regulations and sponsor shipping guidelines.

Adhere to Guideline for Good Clinical Practice (GCP), federal, state, and local regulations, and policies and procedures.

Assists in the coordination of all regulatory activities being conducted at the site.

Provides supervision for all regulatory activities, workflow and regulatory staff.

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.

Assists in the coordination, preparation and submission of IRB applications, IRB continuing reviews, amendments, and modifications.

Maintain current information and knowledge of all applicable policies, local, state, and federal laws and regulations, and accreditation standards.

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 company 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 company policies and procedures.

Participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development as a Clinical Trials Site Supervisor participating in the conduct of clinical trials.

Participate as a member of the clinical trials team and attend meetings, as requested.

Attend meetings for protocol training initiated by company and the Sponsor, as requested.

With direction, perform routine quality control activities and assist with quality improvement initiatives.

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.

À propos de Aerotek SRI: Aerotek SRI est une filiale d'Aerotek® Inc., un important fournisseur de recrutement et dotation technique, professionnel et industriel. Aerotek possède un réseau international de plus de 200 bureaux non franchisés et 2 000 recruteurs pour repérer, présélectionner et choisir les meilleurs talents. About Aerotek ULC: Aerotek ULC is a subsidiary of Aerotek® Inc., a leading provider of technical, professional and industrial recruiting and staffing services. Aerotek operates an international network of more than 200 non-franchised offices and 2,000 recruiters to identify, screen and select top talent. Aerotek is acting as an Employment Agency in relation to this vacancy.