Summary:

Under the general guidance of the Physician Director translates and guides the goals objectives policies and procedures of the department. Directs the standards of clinical research practice in the ambulatory care setting. Has the delegated authority to make decisions in the areas of patient care delivery human resource management and budgetary development and compliance. Collects data monitors programs and assures adherence to established protocols. Coordinates clinical trials data collection involving research teams from other institutions. Analyzes data and in preparation of papers for publication.

Manages all aspects of outpatient clinical trials within the applicable Research department at Rhode Island Hospital. Establishes and maintains department policies procedures and expectations of staff. Develops department policies that are consistent with those of Brown University Health ensuring compliance with all regulatory agencies and that achieve department goals and objectives. Demonstrates competency individually and as part of the team in performing clinical care and assessment of patients. Assists with direct patient care demonstrating maturity and discretion when interacting with patients. Ensures standardized clinical research practices along with thorough compliance of standard practices implementation of Good Clinical Practice (GCP) and training of all staff and faculty working on the clinical research projects. The Clinical Research Nurse Manager will be an advocate for high quality research patient service excellence and overall research compliance.

Responsibilities:

Manages and coordinates activities of all personnel assigned to the unit/project; articulates mission vision and values of the team consistent with overall department priorities and strategies.

Reviews grant and contract expenditures to assure compliance with sponsor requirements Rhode Island Hospital policy and state and federal regulations.

Performs account status review of all studies which includes monitoring spending trends overdrafts resolving small balances on awards review of restricted budgets closing awards and review of subcontractor costs. Performs administrative duties such as planning and budgeting.

Assists in establishing annual budget; monitors expenditures to ensure compliance. Appropriately budgets and coordinators purchase of major equipment.

Serves as expert concerning laws regulations external and internal policies and procedures governing the administration of grants and contracts and serve as a resource of faculty and staff.

Interprets and applies Federal State and agency specific policy procedures and guidelines to individual issues as they arise and ensures consistency with Rhode Island Hospital policy and procedures.

Recommends and drafts changes to department policies and procedures.

Fosters good communication within the team and between the team and its patients.

Ensures that key personnel are compliant with Conflict of Interest Human Subject HIPAA and other training mandates.

Performs financial tasks including quarterly billing.

Interviews and selects clinical research staff. Provides orientation overnight for new staff.

Ensures that employees receive adequate department specific training to thoroughly understand job expectations.

Performs annual performance evaluations within required timeframe providing employee with constructive feedback and assisting in establishing appropriate goals.

Effectively handles employee issues according to HR policies such as employee disputes and performance problems; develops performance improvement plans.

Functions as resource to staff to clarify schedules and practice administrative processes.

Develops and provides in-service education programs for research staff.

Designs in-service education programs utilizing teaching tools and modifies program as needed to effectively train staff.

Evaluates and tracks results for each program.

Maintains required records reports and statistics for administrative purposes and regulatory audits.

Maintains liaison with pharmaceutical companies clinical centers and other participants in the study projects to gather and exchange information. May serve as central resource to coordinator research data collection from multiple outside institutions participating in related investigatory studies. Assures timely and accurate receipt and processing of information for analysis by investigators.

May research literature to assess related findings and to assist in writing papers for publication.

May perform duties of Research Nurse as required with direct patient contact to administer drugs obtain specimens perform ECG's or related functions.

Maintains and enhances professional expertise through participation in appropriate educational acitivies.

May perform other duties as assigned.

Other information:

Education:

Bachelor's Degree level of knowledge including course work in chemistry biology. and pharmacology.

Must have current licensure to practice as a Registered Nurse in the State of Rhode Island or in another state that participates in the Nurse Licensure Compact.

Experience:

At least two years progressively more responsible experience in clinical nursing including experience in a research area.

Interpersonal skills to effectively interact with patients physicians research investigators and other professionals both within and outside the Hospital.

Supervisory skills to direct and evaluate the work of subordinates.

Analytical ability to classify and evaluate data to assess abnormalities or problems with protocols and to monitor a budget.

Organizational ability to develop and maintain records to monitor adherence to protocols and to coordinate data collection from multiple outside sources.

A professional level of knowledge in nursing to assess a wide variety of patients for inclusion in studies and to assess response to treatment.

Demonstrated knowledge and skills necessary to provide care patients with consideration of aging processes human development stages and cultural patterns in each step of the care process.

Supervisory Responsibility:

Supervisory responsibility of at least 6 FTEs.

Brown University Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age ethnicity sexual orientation ancestry genetics gender identity or expression disability protected veteran or marital status. Brown University Health is a VEVRAA Federal Contractor.

Location: Rhode Island Hospital USA:RI:Providence

Work Type: Full Time

Shift: Shift 1

Union: Non-Union