Clinical Trials Specialist -- Surgery FIRST Program

Beth Israel Lahey Health; Boston (MA); On-site; USD 60,000 - 95,000; Full time

Job summary

Beth Israel Lahey Health is seeking a Clinical Trials Specialist to implement, manage and oversee recruitment, screening and enrollment for multiple clinical trials, primarily within the Division of Transplantation.

The role involves budget oversight, grant applications, and monitoring expenses across protocols, ensuring compliance with federal, state and IRB guidelines while supporting staff training and protocol progress.

Qualifications

• Bachelor’s degree required.
• 3‑5 years of related work experience in clinical research.
• Advanced skills with Microsoft applications such as Outlook, Word, Excel, PowerPoint or Access and other web‑based applications.

Responsibilities

• 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 protocol processes for various clinical trials; coordinates sponsor‑initiated visits; 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 (if applicable) and the IRB.

Education

Bachelor’s degree

Academic degree in a scientific discipline

Tools

Microsoft Office

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. The BIDMC Surgery FIRST Program was established in 2017 to provide rigorous support for clinicians engaged in research in the Department of Surgery. The FIRST program is an expansion of the existing research support infrastructure, facilitating the use of existing resources and assisting with tasks associated with study implementation, data collection and storage, biostatistics, and regulation guiding the conduct of research with human research participants. It provides the framework to support and mentor the next generation of clinical investigators who will identify innovative solutions to existing challenges in the care of the surgical patient.

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. The clinical trials specialist will primarily support clinical research and trials within the Division of Transplantation.

Essential Responsibilities

• 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 protocol processes for various clinical trials; coordinates sponsor‑initiated visits; 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 (if applicable) and the IRB.

Required Qualifications

• Bachelor’s degree required.
• 3‑5 years of related work experience in clinical research.
• Advanced skills with Microsoft applications such as Outlook, Word, Excel, PowerPoint or Access and other web‑based applications; may produce complex documents, perform analysis and maintain databases.

Preferred Qualifications

• Prior grant management experience.
• Academic degree in a scientific discipline.
• Knowledge of a foreign language (strongly preferred).

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 determine how to accomplish defined results with some guidance. Manager/Director provides broad guidance and overall direction.

Written Communications

Ability to summarize and communicate 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.

Teamwork

Ability to lead collaborative teams for larger projects or groups both internal and external to the Medical Center and across functional areas.

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 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 throughout the hospital campus.

Pay Range

$60,000.00 USD - $95,000.00 USD (annual base salary range).

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.

Equal Opportunity Employer / Veterans / Disabled.