Clinical Research Assistant II
Department Description: The Cancer Clinical Trials Office (CCTO)
The CCTO provides infrastructure and services to 13 individual cancer disease programs. This group oversees 34 clinical research assistants and coordinators, 18 research nurses/Research NPs, 6 Clinical Trial Specialists, 7 Regulatory and Quality Specialists, 5 Program Managers, 1 Clinical Pharmacy Coordinator, 1 Program Coordinator, 1 Nursing Director, 1 Operations Manager and 1 Administrative Director who oversee nearly 500 clinical trials. The CCTO provides the following: Centralized coordination of new trial submission and oversight of all regulatory requirements; Hiring, training, and mentoring to all CCTO staff members; Guidance and support to all disease groups within the CCTO; Collaboration with the DF/HCC with seats on the IRB, SRC and Operations Committee and acts as liaison with the greater BIDMC oncology, research and general communities.
Job Location: Boston, MA
Req ID: 29920BR
Job Summary: Responsible for screening patients for participation in clinical trials, enrolling patients onto these studies, monitoring protocol implementation, completing required forms and reporting results.
- Assesses potential patients' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol. Recruits and enrolls patients onto clinical trials according to study protocols.
- Checks all eligibility and ineligibility criteria with patients' medical record. Verifies information with clinical research nurse and/or principal investigator.
- Discusses informed consent with patients. Documents any adverse events that occur. Interacts with patients prior to entering the study and throughout the entire treatment. Assists with scheduling appointments and follow up tests.
- Monitors strict adherence to protocols by physicians, nurses and patients. Reviews protocol requirements with physicians, nurses and fellows. Identifies problems with protocol compliance and works with research nurse and principal investigator to make corrections.
- Extracts data on protocol patients from hospital records, outpatient charts and private physician office records in order to complete case report form required by specific protocols.
- Bachelor's degree required. Master's degree preferred.
- 1-3 years related work experience required.
- Bachelors degree and one year experience in a medical setting and/or clinical research or a Master's Degree.
- Knowledge of Medical Terminology.
- Working knowledge of computerized data required including word processing, spreadsheets and databases.
- Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.
- 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 through out the hospital campus