Beth Israel Deaconess Medical Center

Manage daily operations of research pharmacy including medication ordering, preparation, dispensing, documentation, and regulatory compliance. | Licensed pharmacist in Massachusetts with 0-1 years experience, pharmacy degree required, knowledge of research pharmacy operations, and regulatory compliance. | Job Type: Regular Time Type: Full time Work Shift: Day (United States of America) FLSA Status: Exempt When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives. Job Summary: The Research Pharmacist is responsible for the daily operations of the Research Pharmacy. The Research Pharmacist assumes direct responsibility for research medication ordering, receipt, preparation, distribution, control, documentation and record-keeping in accordance with laws and regulations governing pharmacists and the practice of pharmacy by the appropriate state and federal agencies. Job Description: Essential Responsibilities: • Practices in accordance with the laws, rules, and regulations of the Massachusetts Board of Registration in Pharmacy, Department of Public Health, the Food and Drug Administration, and the Drug Enforcement Administration and in accordance with established policies and procedures. Maintains certification and credentials in accordance with the Board of Registration. • Evaluates research medication orders for accuracy and performs clinical interventions as required during dispensation. Communicates with research study teams on discrepancies, possible interactions or changes if necessary. Informs study teams of problems and resolutions. Documents all interventions. • Develops and implements pharmacy preparation and dispensing guidelines for inpatient and outpatient clinical trials as well as off-hours administration if needed. Educates clinical pharmacy staff on research protocols, including but not limited to, management of patient enrollment and proper documentation methods. • Evaluates research protocols and amendments for clinical equipoise, ethical and scientific merit and operational feasibility. • Maintains compliance with all written BIDMC Committee on Clinical Investigations (CCI) and Dana Farber/Harvard Cancer Center (DF/HCC) policies and procedures to ensure the protection of the rights and welfare of human subjects participating in clinical research conducted at BIDMC. Required Qualifications: • Bachelor's degree in Pharmacy required. Doctoral degree in Pharmacy preferred. • License Pharmacist required. • 0-1 years related work experience required. • Licensed Registered Pharmacist in Massachusetts (or immediate eligibility) required • Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access. Preferred Qualifications: • Research Pharmacy/Investigational Drug Service experience in hospital pharmacy, preferably in an academic medical center setting. • Oncology experience in hospital pharmacy, preferably in an academic medical center setting. • Collaborative Institutional Training Initiative (CITI) Certification. 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 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 work collaboratively in small teams to improve the operations of immediate work group by offering ideas, identifying issues, and respecting team members. • 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. Age based Competencies: Employees in this job must be competent to provide patient care to the following age groups: Neonatal:Birth to 6 months, 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 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) as a condition of employment. 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

Prepare and submit regulatory documents for clinical research studies, maintain compliance with FDA and IRB requirements, and act as liaison between investigators and regulatory bodies. | Bachelor's degree required with 1-3 years clinical trial regulatory experience and knowledge of FDA, NCI, OHRP guidelines. | Regulatory Specialist - Clinical Research Coordinator Core Join to apply for the Regulatory Specialist - Clinical Research Coordinator Core role at Beth Israel Deaconess Medical Center Regulatory Specialist - Clinical Research Coordinator Core 13 hours ago Be among the first 25 applicants Join to apply for the Regulatory Specialist - Clinical Research Coordinator Core role at Beth Israel Deaconess Medical Center Get AI-powered advice on this job and more exclusive features. Job Type: Regular Time Type: Full time Work Shift: Day (United States of America) FLSA Status: Exempt When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives. The Regulatory Specialist supports regulatory compliance for clinical research at Beth Israel Deaconess Medical Center (BIDMC). This position provides regulatory support for the projects conducted by the BIDMC Clinical Research Coordinator Core The Clinical Research Coordinator Core provides support for investigator-initiated and sponsor-initiated research for investigators across the departments and divisions of BIDMC. Job Description: Essential Responsibilities: Prepare and submit applications (industry, cooperative groups and PI initiated studies), respond to IRB comments on applications submitted and work with study team in getting studies activated for enrollment of patients. Prepare and assist in submission of protocol amendments, IND safety reports, ADEERS submission, consent form changes, continuing reviews, violations and deviations to study protocols. Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance and troubleshoots processes and procedures when issues are identified. Assist investigators and study teams in preparing and submitting IND applications to the FDA. Preparation and submission of annual reports to the FDA; submission of regulatory documents to NIH/OBA, local bio safety committees on oncology human gene transfer trials. Act as a liaison between the IRB and investigator to resolve regulatory queries and concerns. Assist in the preparation and implementation of regulatory office SOPs. Required Qualifications: Bachelor's degree required; Master's degree preferred in Regulatory Affairs. 1-3 years related work experience required. Must demonstrate good understanding of FDA, cooperative group, NCI and OHRP regulatory guidelines. Must maintain confidential and sensitive information, set own priorities, and work both independently and collaboratively with other research and hospital personnel. Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access. Preferred Qualifications: 1-3 years of clinical trial regulatory affairs experience preferred. Competencies: Written Communications: Ability to communicate clearly and effectively in written English with internal and external customers. Oral Communications: Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers. Knowledge: Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations. Teamwork: Ability to work collaboratively in small teams to improve the operations of immediate work group by offering ideas, identifying issues, and respecting team members. Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Ability to remain calm in stressful situations. Physical Nature of the Job: Sedentary work: Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, with walking and standing required only occasionally. 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 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 Seniority level Seniority level Entry level Employment type Employment type Full-time Job function Job function Research, Analyst, and Information Technology Industries Hospitals and Health Care Referrals increase your chances of interviewing at Beth Israel Deaconess Medical Center by 2x Sign in to set job alerts for “Clinical Research Coordinator” roles. 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