Clinical Research Administrator II - Transplant Institute

Company: Beth Israel Lahey Health
Location: Boston
Posted on: May 29, 2023

Job Description:

When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.
Job Type:
Regular
Scheduled Hours:
40
Work Shift:
Day (United States of America)
BIDMC Transplant Institute is recognized nationally for its scientific contributions, fellowship programs, and success in increasing deceased and living organ donation. Leaders aim to provide the highest quality services to patients, and to advance the quality of care through interdisciplinary patient care, research and preparing future clinicians and scientists. By serving patients today and engaging in research for tomorrow, we serve as leaders in the field of transplantation. The Institute's Clinical Research Group provides infrastructure and personnel for the Institute's clinical research studies. The staff supports a myriad of studies sponsored by industry, philanthropies and government as well as investigator-initiated trials. Current studies involve evaluation of novel drug treatments for kidney and liver transplant patients and diagnostics for early detection of graft injury. Through these special studies, patients are invited to participate in experimental treatments prior to FDA approval and more wide spread accessibility.
Job Description:
Job Summary: This position is responsible for the overall management and coordination of clinical research activities in a specialty area. These responsibilities include the oversight of scheduling study related procedures and study patient appointments, as well as maintaining subject follow-up. The incumbent will play a key role in maintaining and attracting new research projects and clinical trials to the division.
Essential Responsibilities:
Demonstrate and maintain proficient knowledge of a specialty area as they relate to clinical trials, patient care adhering to the principles of human subjects' compliance, IRB processes, regulatory issues, and clinical trials compliance, including the preparation of new IRB applications and follow-up amendments/continuing reviews and presentation of study.
Manage clinical trials accounts and the distribution of funds as necessary, including the development of study budgets. Recruit, consent, enroll and monitor patients in clinical studies as well as educate patients on follow-up criteria and care guidelines assuring study compliance. Develops and implements screening strategies for each trial. Works in cooperation with other departments.
Acts as a resource to staff; attends laboratory meetings, case conferences, Investigator meetings as indicated.
Participates in the planning, implementation of in-services and education related to the specialty area. Examine, assess, and make clinical judgments in documenting and reporting adverse events to study sponsor and IRB. Assesses patient participation on a continuous basis.
Meet trial enrollment and complement needs and recruitment plan for the clinical trial. Develops and implements screening strategies for each trial. Provides cross training and cross coverage strategies where necessary.
Performs required nursing procedures required by protocols based upon sound scientific principles, hospital guidelines, policies and protocol criteria.
Has the authority to direct and support employees daily work activities. Has the direct responsibility to undertake the following employment actions: hiring, termination, corrective action and performance reviews. Direct Reports: More than 7 Indirect Reports: None
Has full responsibility for planning, monitoring and managing department budget.
Required Qualifications:
Bachelor's degree in Nursing required; Master's degree in Nursing preferred.
Registration Registered Nurse required.
8-10 years related work experience required and 1-3 years supervisory/management experience required
Completion of CITI training within 6 weeks of hire and recertification every three years thereafter.
Appropriate license/registration/certification appropriate to the specialty area.
Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint or Access and other web-based applications. May produce complex documents, perform analysis and maintain databases.
Competencies:
Decision Making: Ability to make decisions that are guided by precedents, policies and objectives. Regularly makes decisions and recommendations on issues affecting a department or functional area.
Problem Solving: Ability to address problems that are broad, complex and abstract, often involving Medical Center-wide issues and requiring substantial creativity, resourcefulness, staff engagement, Lean diagnostic techniques, negotiation and diplomacy to develop solutions.
Independence of Action: Ability to set goals and priorities for functional area. May make recommendations for department policies, practices and programs. Manager or Director provides broad guidance and overall direction.
Written Communications: Ability to communicate complex information in English effectively in writing to all levels of staff, management and external customers across functional areas.
Oral Communications: Ability to verbally communicate complex concepts in English and address sensitive situations, resolve conflicts, negotiate, motivate and persuade others.
Knowledge: Ability to demonstrate broad and comprehensive knowledge of theories, concepts, practices and policies with the ability to use them in complex and/or unprecedented situations across multiple functional areas.
Team Work: Ability to lead collaborative teams for larger projects or groups both internal and external to the Medical Center and across functional areas. Results have implications for the management and operations of multiple areas of the organization.
Customer Service: Ability to lead operational initiatives to meet or exceed customer service standards and expectations in assigned unit(s) and/or across multiple areas in a timely and respectful manner.
Age based Competencies:
Employees in this job must be competent to provide patient care to the following age groups: Young adult: 16-30 years, Middle Age: 30 - 60 years, Elderly: 60 -.
Physical Nature of the Job:
Light work: Exerting up to 20 pounds of force frequently to move objects. Some elements of the job are sedentary, but the employee will be required to stand for periods of time or move through out the hospital campus
FLSA Status:
Exempt
As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment. Learn more (https://www.bilh.org/newsroom/bilh-to-require-covid-19-influenza-vaccines-for-all-clinicians-staff-by-oct-31) about this requirement.
More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.
Equal Opportunity Employer/Veterans/Disabled

Keywords: Beth Israel Lahey Health, Boston , Clinical Research Administrator II - Transplant Institute, Healthcare , Boston, Massachusetts