Clinical Trials Specialist
Department Description: I, Dr. Mara Schonberg, am seeking a full time Clinical Trials Specialist. The position is at Beth Israel Deaconess Medical Center in the Division of General Medicine and Primary Care. My research aims to improve shared decision making around cancer screening and treatment for older adults, particularly for breast cancer. I also work with many trainees doing research in other pressing areas of primary care such as optimizing use of telemedicine, improving end of life care, and reducing health care disparities. Under my Direction, the incumbent is responsible for recruiting, screening and enrolling patients, generally older women, for participation in clinical research studies. The incumbent monitors the progress of protocols, helps prepare materials for the IRB, and assists with the grant application and reporting process. The incumbent also conducts a variety of routine and specialized research duties including project coordination, data management and analysis, literature searches, and presentation and manuscript preparation. The incumbent must have excellent organizational, communication and analytical skills normally acquired through a BA/BS degree or equivalent. Masters level degree or related coursework in public health related field a plus. The incumbent must have demonstrated proficiency with Microsoft Word, Excel, and PowerPoint and a general knowledge of research methods. The incumbent must be attentive to detail and able to communicate effectively, orally and in writing; be able to take direction well but also set own priorities and work both independently and collaboratively with research investigators, staff and hospital personnel. Incumbent must possess excellent English language and interpersonal skills, and have a professional and effective telephone presence in order to recruit older adults over the telephone when needed. Knowledge and/or interest in women’s health and aging is preferred. This role is also designed to help the incumbent reach their professional goals, whether it be to go medical school, graduate school, industry, or research administration. The salary is competitive and based on experience.
Job Location: Boston, Massachusetts
Req ID: 47866BR
Job Summary: The Clinical Trials Specialist is responsible for implementing; managing; and overseeing the recruiting, screening and enrolling of subjects for participation in multiple clinical trials to ensure compliance with federal, state and institutional guidelines. Financial responsibilities include preparing budgets, overseeing the grant application process and monitoring expenses for all protocols. Additional duties include overseeing the progress of protocols and planning and prioritizing the work of the Clinical Research Staff.
- Partners with Principal Investigator (PI) to hire, train and coach Clinical Research Staff. Provides feedback to PI regarding annual performance evaluations of staff. Ensures that schedules, follow-up and completion of research protocols progresses as planned. Works with staff to resolve day-to-day problems.
- Implements process of protocol for various clinical trials; coordinates sponsor conducted initiated visit(s); assists in the execution of new IRB applications and processes annual reviews for the IRB committee with regard to consents.
- Collaborates with PI and/or Research Nurse in submission of protocols, amendments, notices, suspensions and terminations to the IRB for review and approval. Attends IRB meetings as required and addresses any IRB questions regarding the protocols or consent forms.
- Assesses potential patients' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol. Checks all eligibility or ineligibility criteria with the patients' medical record. Verifies information with Research Nurse and/or PI. Enrolls patients onto clinical trials or oversees enrollment process.
- Discusses and obtains informed consent with patients. Revises protocol consent form to comply with federal, state and IRB guidelines. Interacts with patients prior to entering the study and throughout the entire treatment. Monitors the occurrence of adverse events and reports them according to the guidelines of the FDA, sponsoring drug accompany (if applicable) and the IRB.
- Monitors strict adherence to protocols by physicians, nurses and patients. Reviews protocol requirements with physicians, nurses and fellows. Identifies and resolves problems with protocol compliance. Keeps PI and Research Nurse aware of any problems.
- Prepares records for audits. Interacts with industry or sponsoring organization representatives to review records at time of audits. Answers queries from sponsoring organization regarding ambiguous or incomplete data. Assists PI in reviewing data from research protocol in order to assess efficacy of therapy and make subsequent treatment decisions.
- Oversees the application process for grants ensuring compliance with funding agencies and assists PI in the preparation of annual progress report of the grant. Develops financial and statistical reports. Prepares budgets and monitors expenses related to each protocol. May assist the PI in obtaining new sources of funding.
- Bachelor's degree required.
- 3-5 years related work experience required.
- Knowledge of medical terminology.
- 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.
- Prior grant management experience.
- Academic degree in a scientific discipline.
- 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 highly varied, complex and often non-recurring, requiring staff input, innovative, creative, and Lean diagnostic techniques to resolve issues.
- Independence of Action: Ability to set goals and determines how to accomplish defined results with some guidelines. Manager/Director provides broad guidance and overall direction.
- Written Communications: Ability to summarize and communicate in English moderately complex information in varied written formats to internal and external customers.
- Oral Communications: Ability to comprehend and communicate complex verbal information in English to medical center staff, patients, families and external customers.
- Knowledge: Ability to demonstrate in-depth knowledge of concepts, practices and policies with the ability to use them in complex varied situations.
- 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 provide a high level of customer service and staff training to meet customer service standards and expectations for the assigned unit(s). Resolves service issues in the assigned unit(s) in a timely and respectful manner.
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
BIDMC is EOE M/F/VET/DISABILITY/GENDER IDENTITY/SEXUAL ORIENTATION
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. BILH requires that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment.