Clinical Research Assistant I
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: 28350BR
Job Summary: Responsible for screening research subjects for participation in clinical research projects, enrolling research subjects onto these studies, monitoring protocol implementation, completing required forms and reporting results. Works closely with other clinical research staff.
- Independently or in conjunction with other clinical research staff and/or research nurse, recruits and enrolls research subjects onto clinical research projects according to study protocols. May assess research subjects' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol.
- Checks all eligibility and ineligibility criteria with the research subjects' medical record. Verifies information with clinical research nurse and/or principal investigator.
- Discusses informed consent with research subjects. Interacts with research subjects prior to entering the study and throughout the entire treatment. Assists with scheduling appointments and follow up tests.
- Learns protocol and monitors strict adherence to protocols by physicians, nurses and research subjects. Reviews protocol requirements with physicians, nurses and fellows. Identifies any problems with protocol compliance and notifies principal investigator and/or research nurse. Begins to learn how to independently resolve problems with protocol.
- Extracts data on protocol subjects from hospital records, outpatient charts and private physician office records in order to complete case report forms required by specific protocols. Enters data into computerized system.
- Bachelor's degree required.
- 0-1 years related work experience required.
- Working knowledge of computerized data (word processing, spreadsheets, and database).
- Medical terminology.
- Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.
- Previous clinical research project experience.
- Decision Making: Ability to make decisions that are based on specific instructions, standard practices and established procedures which generally require little or no supervision.
- 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