Clinical Trials Specialist

About the role

The Clinical Trials Specialist plays a crucial role in the Richard A. and Susan F. Smith Center for Outcomes Research at BIDMC. This position engages in a variety of collaborative research projects, working closely with clinician investigators, statisticians, administrative staff, and trainees. The specialist helps produce high-impact research funded by organizations like the National Institutes of Health, the American Heart Association, and the US Food & Drug Administration.

Responsibilities

• Partners with Principal Investigator (PI) to hire, train, and coach Clinical Research Staff.
• Ensures schedules, follow-up, and completion of research protocols progress as planned.
• Works with staff to resolve day-to-day problems.
• Implements process of protocol for various clinical trials; coordinates sponsor conducted 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.
• Affirms 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. Revise protocol consent form to comply with federal, state, and IRB guidelines.
• Interacts with patients prior to entering the study and throughout the entire treatment.
• Maintains a close watch on the occurrence of adverse events and reports them according to the guidelines of the FDA, sponsoring drug accompany (if applicable), and the IRB.

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.

Qualifications

• Prior experience with clinical trial enrollment including experience with IRB submissions and patient enrollment is expected.

Skills

• Decision Making: Ability to make decisions that are guided by precedents, policies, and objectives.
• 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 guidelines.
• 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.
• Teamwork: Ability to lead collaborative teams for larger projects or groups both internal and external to the Medical Center and across functional areas.
• Results Have Implications for the Management and Operations of Multiple Areas of the Organization: Demonstrates the ability to make decisions that affect the management and operations of multiple areas of the organization.
• 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: Demonstrates the ability to resolve service issues in the assigned unit(s) in a timely and respectful manner.

Benefits

The Smith Center for Outcomes Research at BIDMC offers a supportive environment for its employees, including access to comprehensive benefits packages that may include:

• Health insurance
• Retirement plans
• Flexible spending accounts
• Employee assistance programs
• Professional development opportunities

Pay

$60,000.00 USD - $95,000.00 USD. Actual compensation is determined based on several factors, including seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law.