GENERAL SUMMARY/OVERVIEW STATEMENT:
Works independently and under general supervision of a manager or Project Leader(s) and following established policies and procedures, provides assistance and support on research and clinical studies. May be responsible
for the following activities: recruiting, advertising and evaluating human research subjects for studies; collecting and organizing subject data; scheduling subjects for study visits, performing clinical tests such as ECG's, etc; maintaining and updating data generated by the study.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1.Coordinates the implementation of research studies both within the BWH community as well as with external vendors, professionals, and stakeholders.
2.Initiates and maintains contact with study participants, via telephone, mail and/or email. Responsible for screening applicants, ensuring they satisfy all inclusion/exclusion criteria for the protocol, and in conjunction with the Project Leader(s) make judgments as to the eligibility of the potential subject.
3.Working in concert with the Project Leader(s) develops and implements study subject recruitment strategies that are effective in meeting project goals while adhering to budget limits. This includes designing and placement of advertising, analyzing data to determine the most effective advertising strategies for the target population
4.Develops, organizes and/or maintains participant information database for study to meet internal (e.g. department, Partners Human Research Committee, IRB) and external (e.g.NIH, FDA, etc.) guidelines and requirements. Required to input and check data, and prepare and present weekly, monthly and annual reports.
5.In conjunction with the Project Leader, develops and prepares materials necessary for the implementation of research protocols including study design, internal review board approval (IRB) applications/amendments and reports, data collection systems, and methods, screening materials etc. Will be required to perform and or schedule clinical tests such as ECGs and psychological exams and to schedule tests with internal and external professionals.
6.Responsible for preparing and tracking payments to study participants, professionals, outside vendors, and others in support of study activities, in conjunction with the DSM financial administrator. Responsible for tracking spending on participant recruitment and screening costs for study and providing regular updates to Project Leader, PI, Financial Administrator and/or Project Manager.
7.Responsible for study specific equipment and for assisting Project Leader in testing, setting up, and training other staff on study equipment. Monitors study events and data collection activities during the study.
8.Assists PL(s) in organization, cleaning/editing and analysis of data during and/or following the study.
9.Assist the Principal Investigator/Project Leader with preparation of study generated information for presentations and manuscripts.
10.Acquire and maintain certification from the Center for Clinical Investigation and/or other relevant Hospital research cores for data collection of blood drawing, polysomnographic recordings, and general procedures. Participates in experimental data collection at the BWH CCI when required.
11. All other duties as required.
BS or BA
At least one year experience in a clinical research setting and /or customer service or related experience. Sound independent judgment and competence in research methodologies.
Prefer an individual with a background in psychology, neuroscience, biology or related fields.
Working knowledge and proficiency with the following computer software: Microsoft Office (Word, Excel, PowerPoint and email).
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
Ability to work independently in a busy, open office setting with several other employees.
Excellent interpersonal skills are required.
Excellent oral and written communication skills.
Ability to learn and understand clinical research protocols and study goals
Ability to maintain good working relationships within the Division and with staff members in other departments
Knowledge of computer programs, database, etc.
Excellent organizational skills and ability to prioritize a variety of tasks.
Careful attention to detail.
Ability to demonstrate professionalism and respect for subject rights and individual needs and to maintain confidentiality
Must be able to be HIPPA compliant at all times.
Ability to learn new technical skills and perform them with competency
Ability to work non-standard work shifts (e.g., evenings, overnights, and/or weekends).
Busy and fast paced academic/ research office setting. The employee will work in an open area with several other employees. Requires regular interactions with other BWH departments.
Potential exposure through contact with biological specimens.
Night, weekend, and/or holiday work will be required.
May be responsible for training and orienting new staff.
Must track and process invoices and payments for study-related items, exams, etc. in conjunctions with DSM Financial Manager. Must plan advertising strategies within a target budget set by Project leader/ PI.
May interface with vendors or study subjects in the event of a payment problem.
Partners Healthcare System