Clinical Trials Specialist

Beth Israel Lahey Health•Boston, MA

2d•Onsite

About The Position

The Richard A. and Susan F. Smith Center for Outcomes Research at BIDMC is seeking a Clinical Trials Specialist. The Smith Center is devoted to addressing the most pressing issues in cardiovascular care through innovative and rigorous analysis of data. The Clinical Trials Specialist will engage in a variety of collaborative research projects working closely with clinician investigators, statisticians, administrative staff and trainees. The Smith Center faculty are highly active in nationally recognized cardiovascular research and produce numerous important publications each year. As Specialist you will have a key role in helping produce high-impact research. Our research is funded by various organizations including the National Institutes of Health, the American Heart Association, and the US Food & Drug Administration, as well as grants and contracts from the health science industry. The individual will responsible for the clinical research activities of the Section of Cardio-Oncology and Heart Failure Research (led by Dr. Upshaw). The Cardio-Oncology and Heart Failure section combines the use of randomized clinical trials and real-world data with advanced statistical and epidemiological methods to answer questions related to the intersection between cancer and heart disease. Our work, primarily funded by the NIH: 1) evaluates novel interventions to improve cardiovascular health in patients with cancer and 2) investigates the epidemiology of cardiovascular disease in patients with cancer in the US. The Clinical Trials Specialist will help manage research projects including study coordination for an ongoing multicenter randomized controlled trial and managing multiple research projects using observational or real world datasets. The variety of tasks associated with this position include but are not limited to the following: assisting with IRB communications and documentation, coordinating study activities, coordinating in-person or remote research meetings with investigators and study personnel at multiple sites, assisting with scientific writing (including drafting manuscripts, research progress reports, abstracts, posters, and PowerPoint presentations) and assistance with grant applications and administrative tasks such as calendar management and reimbursements.

Requirements

Bachelor's degree required.
3-5 years related work experience required in clinical research.
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 experience with clinical trial enrollment including experience with IRB submissions and patient enrollment is expected.

Nice To Haves

Prior grant management experience.
Academic degree in a scientific discipline.
Ability to converse and comprehend in a foreign language would be strongly preferred.

Responsibilities

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.
Preparing budgets, overseeing the grant application process and monitoring expenses for all protocols.
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.