Clinical Investigation Technician I Rotating BWH Sleep Medicine

GENERAL SUMMARY/ OVERVIEW STATEMENT:

Working under general supervision of a manager or project leader and following established policies and procedures, assists in the execution of clinical research protocols and operations in the Division of Sleep and Circadian Disorders (DSCD). Responsible for assisting with the recruitment of study participants; collection of physiologic data using specialized data collection equipment, administration of computerized and pencil-and-paper tests and questionnaires, collection of biological samples, monitoring data collection equipment, monitoring study participants, ensuring adherence to study protocols, organizing data, performing data processing and analysis, writing reports; tracking spending.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

1. Recruits and evaluates human research subjects for studies. Answers any telephone/Email/online inquiries from

potential subjects in a timely manner. Conducts telephone/video interviews, administers online and in-person screening

questionnaires, and reviews results to determine inclusion/exclusion according to established guidelines. Schedules

patients/subjects for screening visit(s) and study procedures according to Division SOPs. Interacts with human research

subjects with regard to study, including human research subject education, procedural instructions, informed consent,

follow-up. Coordinates scheduling of study between subject, study team, and others. Carries out admission and

discharge procedures for studies. Performs clinical tests such as EKGs, vitals, EEGs, and administers

psychological exams. May require sending equipment, paperwork, or other materials to study participants, and/or

receiving shipments or drop-offs of equipment, specimen, paperwork/documents from study participants.

2. Performs data collection activities for research studies at the at BWH, and in field studies.

* Physiologic data collection: uses equipment and sensors to collect physiologic signals from study participants following standard or study-specific procedures. Able to troubleshoot equipment and sensor problems, download data, with minimal supervision.
* Biological specimens: collects and prepares urine, blood and saliva samples from study participants for later assay; transports specimens between locations using standard procedures; ships specimens using standard procedures.
* Performance tests and questionnaires: monitors computer-controlled administration of neurobehavioral tests using central data collection systems; recovers computers after system failures according to standard procedures with minimal supervision. Administers written tests and questionnaires using standard procedures. Administers tests using stand-alone computers and software.
* Subject monitoring and protocol execution activities: ensures study protocol events are carried out as scheduled in study orders and/or event scheduling system and occur on time while following SOPs; uses data collection systems to collect and record key study information according to CCI, DSCD, and study SOPs; monitors study participants to ensure they comply with study protocol and they remain in good health; communicates any deviations in study protocol, equipment malfunctions, and participant discomfort or complaint to the appropriate personnel;
* Provides feedback on areas of workflow improvement and quality improvement.

3. Organizes and processes study data.

* Creates and maintains databases/files containing study data using standard Division practices.
* Scores written tests and questionnaires using standard score sheets and criteria; enters scores into worksheets and databases.
* Compiles data from multiple testing sessions/subjects for data analysis.
* Reviews study records to determine whether specific tests, samples, or other data were not collected according to protocol, enters such information into tables, edits such information from dataset copies using standard Division practices.
* Performs statistical and graphical analysis.

4. Assists Investigators and other study personnel in preparing for and carrying out studies.

* Prepares IRB, CTSC, grants, and other applications.
* Maintains and orders supplies, prepares equipment, and ensures other materials for conducting studies are available in the correct location at the time needed.
* Prepares questionnaires, inventories, and databases using RedCAP and other research tools; updates existing projects as needed.
* Drafts and/or modifies written procedures for study-specific events/data procedures.
* Carries out standard and study-specific events as outlined in the study orders, DSCD/CCI SOPs, and other written documents.
* Acts as a liaison between Investigators, hospital staff, CCI technical staff, administrative staff, subject recruiters, and research subjects to identify areas for quality and workflow improvements.

5. Assists Investigator in research activities.

* Maintains records, keeps inventories, and reconciles expenditures and income for specific projects.
* Performs literature searches, reviews literature, enters papers into reference database, compiles and checks reference lists for manuscripts, grants, and other written reports.
* Drafts text for reports, manuscripts, abstracts, grants. Prepares tables and figures.
* Assists in orienting and training new employees for specific projects.

6. Follows Infection Control, Electrical Safety and other guidelines as mandated by BWH, OSHA, or other regulatory agencies; follows HIPPA and Human Research guidelines as mandated by DHHS. Follows all standard operating procedures for the Chronobiology Core of the Division of Sleep and Circadian Disorders, the Center for Clinical Investigation, and BWH; follows study-specific procedures.

7. Performs all other duties and projects as assigned.

QUALIFICATIONS:

1. BA/BS degree required; health science, biology, neuroscience, psychology or related area preferred.

2. Prior experience working with subjects/patients, and working on a research team preferred.

3. Prefer individuals with independent research experience (e.g., thesis project).

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

* Excellent interpersonal skills, able to maintain positive working relationships with co-workers and to work cooperatively with peers, able to perform his/her role in a team effort.
* Excellent organizational skills, and ability to prioritize and manage time efficiently.
* Ability to follow directions carefully, and once trained, to work with a minimum of direct supervision.
* Excellent oral and written communication skills.
* Excellent reasoning skills. Ability to exercise initiative and sound judgment in unexpected situations.
* Highly competent with using and troubleshooting computers and equipment.
* Physically able to assist with the moving of testing supplies and equipment.
* Willing to accept additional work (new projects, overtime) when required.
* Ability to continually learn new technical skills and update existing skills.
* Able to learn and use a variety of software programs.
* Ability to teach peers, graduate students, post-doctoral fellows, and other researchers technical knowledge and skills.

WORKING CONDITIONS:

Day, evening, overnight, weekend and holiday shifts will be required. Occasional last-minute shift changes due to participant cancellations.

Busy research environment. Occasional intense periods of work can be associated with particular scientific deadlines.

Potential exposure to blood-borne disease through contact with biological specimens.