Job Type: RegularTime Type: Full timeWork Shift: Rotating (United States of America)FLSA Status: Non-ExemptWhen you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.Responsible for managing/overseeing the recruiting, screening and enrolling of patients for participation in multiple clinical trials, ensuring compliance with federal, state and institutional guidelines. Financial responsibilities including assisting with the grant application process and monitoring expenses for all protocols. Supervisory duties including overseeing the progress of protocols; supervising, planning and prioritizing the work of the Clinical Research Coordinators.Job Description:Essential Responsibilities:
Participates in hiring and training Clinical Research Coordinators. Monitors performance of staff. Contributes to annual performance evaluations of staff. Ensures that schedules, follow up and completion of research protocols progress as planned. Works with staff to resolve day-to-day problems. (essential)
Assists in the execution of new IRB applications and processes annual reviews for the IRB committees with regard to consents. May attend IRB meetings as required or address IRB questions regarding the protocols or consent forms. Working with the principal investigator and/or research nurse, submits protocols, amendments, notices, suspensions and terminations to the IRB for review and approval. (essential)
Interacts with patients prior to entering the study and throughout the entire treatment. Discusses and obtains informed consent with patients. Revises protocol consent form to comply with federal, state and IRB guidelines. (essential)
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 clinical research nurse and/or principal investigator. May enroll patients onto clinical trials. (essential)
Monitors the occurrence of adverse events and reports them according to the guidelines of the FDA, sponsoring drug accompany (if applicable) and the IRB. May interact with sponsors and/or pharmaceutical company representatives. May prepare reports for pharmaceutical company monitors as well as routine audits for the FDA, if applicable. (essential)
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 principal investigator and research nurse aware of any problems. (essential)
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. Monitors quality and timeliness of data submissions. Ensures data extracts completed by staff are in compliance with protocols. (essential)
May assist physician investigator in reviewing data from research protocol in order to assess efficacy of therapy and make subsequent treatment decisions. Serves as a resource to physicians and nurses to locate information for special reports and treatment decisions. (essential)
Ensures compliance with funding agencies and assists principal investigator in the preparation of annual progress report of the grant. May oversee the application process for grants. Develops financial and statistical reports. Monitors expenses related to each protocol. May work to prepare budget. (essential)
May assist the principal investigator in obtaining new sources of funding and negotiating with prospective sponsors and collaborating institutions. Must have full understanding and ability to explain research protocols thoroughly including goals, methods and design. (essential)
Required Qualifications:
Bachelor's degree required; Master's degree preferred.
1-3 years of related work experience in a medical setting; clinical research setting preferred.
Knowledge of Medical Terminology.
Working knowledge of computerized applications, including web-based applications and Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.
Competencies:Decision Making: Ability to make decisions that are guided by general instructions and practices requiring some interpretation. May make recommendations for solving problems of moderate complexity and importance.Problem Solving: Ability to address problems that are routine, somewhat repetitive and generally solved by following clear directions and procedures and by identifying opportunities for process improvements.Independence of Action: Ability to follow general instructions and procedures as provided. Work is monitored by supervisor/manager.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.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 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: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 throughout 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) 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
