Working under general supervision from manager or PI, providing support to clinical research studies. Independently coordinates all activities of clinical trials and clinical research including but not limited to supervising the daily activities of research assistants, implementing, and maintaining quality assurance procedures, designing research protocols, and overseeing and conducting study enrollment and activities. This position is seeking a Senior Research Assistant for clinical trial activities and management.

PRINCIPAL DUTIES AND RESPONSIBILITIES:
1. Serve as team lead to the group of Research Assistants, including guidance and instruction, workflow reassignment as needed. Working with Program Manager and PI to discuss team function and performance.
2. In collaboration with PI and Program Manager, develops, implements and/or maintains an orientation and training program for study staff.
3. Coordinates the implementation, both internally and externally, of sponsored clinical research studies.
4. Function as a resource for all study issues. Identifies problems and develops solutions, independently or in conjunction with study managers.
5. Initiate and maintain contact with study participants, study scheduling, and participant screening.
6. Designs, implements, and evaluates recruitment strategies for study participants.
7. Perform applicable tests as per protocol, defined by project role.
8. Interact with patients/subjects regarding study, including patient education, procedural instruction, follow-up. May serve as a liaison between patient and physician.
9. Conducting and overseeing the data collection process. Ensures integrity of patient data.
10. Develops, organizes, and/or maintains the study forms. Responsible for data validation and quality control, data entry into CRFs, if applicable. May be required to input data and do minimal analysis and run various reports.
11. Implements and maintains quality assurance procedures and systems.
12. In collaboration with PI and manager, develops and implements new research protocols including design, data collection systems, and institutional review board (IRB) approval.
13. Assorted administrative work on participant and regulatory documentation. Address study-related phone calls and emails.
14. Maintain study compliance and any IRB and/or FDA reporting.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:
* Ability to work independently and display initiative to introduce innovations to research study.
* Excellent interpersonal skills with patients/participants and co-workers.
* Excellent oral and written communication skills.
* Strong analytical skills and conceptual thinking. Ability to resolve technical or research problems and issues and to interpret the acceptability of data results.
* Ability to prioritize tasks and set deadlines.
* Ability to identify problems and develop solutions.
* High degree of computer literacy.
* Careful attention to detail.
* Ability to demonstrate professionalism and respect for subjects' rights and individual needs.

QUALIFICATIONS: * BS or BA, equivalent experience, or research certification acceptable as well
* 3-5 years of directly related, progressively more responsible, experience.
* Supervisory experience preferred.
* Experience with phase I-IV clinical trials preferred.
* knowledge of medical terminology, clinical practice and/or research studies highly desired.
* Sound independent judgment and willingness to learn competence in research methodologies a must.

WORKING CONDITIONS:

* Working within clinical and dry office space.
* Occasional laboratory exposure, no specific duties.
* Exposure to biological fluids, i.e. blood, urine, CSF, stool.
* No lifting over 25 pounds.

SUPERVISORY RESPONSIBILITY:

* Responsible for directly supervising Research Assistants in area.
* Trains staff, in addition to assisting with hiring and evaluating of Research Assistants.
* Coordinates staffing and schedule.

BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.