Department Description: Cancer Clinical Trials Office (CCTO)
The CCTO oversees clinical research assistants (CRAs), research nurses, regulatory specialists, research pharmacists, quality management specialists, program managers and a program coordinator. The CCTO manages approximately 300 clinical trials, and is organized into thirteen disease groups.
This Clinical Trials Specialist (CTS) position will support the Hematologic Malignancies research division. The clinical trial portfolio encompasses Phase I-III trials in leukemia, lymphoma, multiple myeloma, cellular therapies, and bone marrow transplant. The CTS is primarily responsible for project oversight for a portion of trials within these disease areas.
Job Location: Boston, MA
Req ID: 30946BR
Job Summary: 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.
Department Specific Job Responsibilities:
- Collects, compiles and analyzes research data. Reviews and analyzes significant data and statistics. Works to ensure that appropriate control systems are in place to monitor the progress of data acquisition and to define new approaches to data management. Serves as a resource in providing statistical information from the database.
- Organizes, establishes and maintains the research database and uses the database to extract information for reports, papers and feedback to the team.
- Assists with preliminary planning for the study including performing literature searches and developing data forms. Demonstrates understanding and knowledge of designated study protocols and methods of implementation. Assists in the formulation of research aims and protocols.
- Collects blood samples and sets up blood draw kits; arranges transport of samples for processing. Collects, analyzes and assures the quality of pertinent patient documentation according to established guidelines. Maintains confidential patient files including all correspondence, information, raw data and follow-up status of all study patients.
- Organizes project team meetings and prepares the agenda under direction of the PI. Assesses patient participation on a continuous basis in light of ethical considerations. Acts as liaison between patient and other members of the team regarding the research protocol.
- 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.
- Bachelor's degree required.
- 3-5 years related work experience required.
- Knowledge of medical terminology.
- 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 grant management experience.
- Licensed Registered Nurse strongly preferred.
- 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 determines how to accomplish defined results with some guidelines. Manager/Director provides broad guidance and overall direction.
- 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.
- Team Work: 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.
- 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.
Employees in this job must be competent to provide patient care to the following age groups: Young adult: 16-30 years, Middle Age: 30 - 60 years, Elderly: 60 -.
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 through out the hospital campus Employment Type: Full Time