Senior Clinical Research Coordinator

Beth Israel Deaconess Medical Center, Inc.; Boston (MA); On-site; USD 50,000 - 75,000; Full time

Job summary

Beth Israel Deaconess Medical Center is seeking an experienced Senior Clinical Research Coordinator to provide operational, regulatory, and patient-facing leadership across multiple trials. Embedded in the Clinical Research Coordinator Core, you will ensure compliance with federal and institutional regulations while maintaining high standards of participant care and engagement.

You will guide Clinical Research Coordinators, oversee recruitment, screenings, and study visits, and prepare

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.
• Web-based applications and Microsoft Office proficiency.

Responsibilities

• Participates in hiring and training Clinical Research Coordinators.
• Monitors performance of staff.
• Contributes to annual performance evaluations of staff.
• Ensures schedules, follow up and completion of research protocols progress as planned.
• Assists in IRB submissions and conducts annual reviews.
• Discusses informed consent with patients and revises consent forms as needed.
• Monitors eligibility of potential patients and may enroll patients onto trials.
• Monitors adverse events and reports per FDA guidelines.
• Prepares records for audits and reviews data quality for protocol compliance.
• Assists in budget development and financial reporting for protocols.

Skills

Regulatory compliance

Coordination

Spanish/Portuguese language

Stakeholder engagement

Team leadership

Education

Bachelor's degree

Master's degree preferred

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Access

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. Beth Israel Deaconess Medical Center is seeking an experienced and culturally competent Senior Clinical Research Coordinator to provide operational, regulatory, and patient-facing leadership across a portfolio of assigned clinical trials. This position is embedded within the BIDMC Clinical Research Coordinator Core, a centralized resource serving investigators across departments and divisions throughout the medical center, and operating in affiliation with the institution's Clinical Research Center, a member of Harvard Catalyst - Harvard's Clinical and Translational Science Center. In this senior-level role, the successful candidate will serve as the primary operational lead for multiple concurrent clinical trials, ensuring rigorous compliance with federal, state, and institutional regulations while maintaining a high standard of participant care and engagement. Core responsibilities include overseeing all phases of participant engagement - including recruitment, screening, enrollment, and study visits - managing regulatory documentation, and preparing and submitting regulatory and IRB submissions in accordance with applicable guidelines. The Senior Clinical Research Coordinator will also be responsible for guiding the day-to-day work of Clinical Research Coordinators, setting priorities, and monitoring protocol progress to ensure timelines and deliverables are met. Fluency in Spanish and Portuguese is strongly preferred, as this role requires direct engagement with diverse patient populations across multiple therapeutic areas. This position supports research activities at BIDMC's main Boston campus as well as affiliated community health centers, reflecting the institution's commitment to equitable and accessible research participation.

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.

Pay Range:

$24.04 - $36.06 The pay range listed for this position is the base hourly wage range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. Compensation may exceed the base hourly rate depending on shift differentials, call pay, premium pay, overtime pay, and other additional pay practices, as applicable to the position and in accordance with the law.

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 At Beth Israel Lahey Health, we are driving the change in health care that Massachusetts wants and needs.

Our culture promotes continuous learning, growth, innovation and a sense of belonging. We make it a priority to offer comprehensive compensation and benefits and help you achieve a healthy and balanced life.

While you're busy caring for and supporting our patients, we take care of you.