Clinical Research Assistant II
Department Description: Research-Vaccine Research
Job Location: Boston, MA
Req ID: 37107BR
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.
The following statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of this position.
1. 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. (essential)
2. Checks all eligibility and ineligibility criteria with the research subjects' medical record. Verifies information with clinical research nurse and/or principal investigator. (essential)
3. 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. (essential)
4. 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. (essential)
5. 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. (essential)
6. Assists clinic staff in obtaining insurance approval for subject protocol participation and scheduling tests and arranging admissions or outpatient visits for subjects. (essential)
7. Assists investigator with correspondence with IRB. (essential)
- Bachelor's degree required.
- 1-3 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