The Lead Research Assistant will work under the supervision of the Program Coordinator and Principal Investigator and will follow established policies and procedures to coordinate the conduct of investigator-initiated and corporate-sponsored clinical research trials. The Lead Research Assistant will be responsible for, but not limited to, the following activities: supervising the daily activities of research staff, implementing and maintaining quality assurance procedures, designing research protocols with the Principal Investigator, recruiting and evaluating patients for studies, collecting and organizing patient data, scheduling patients for study visits, entering and managing databases, and assisting in the preparation of manuscripts. The position provides opportunity for professional growth.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Employees may not perform all duties described but should have the ability to perform them if necessary.
Oversees/assists in the coordination of clinical research studies as per study guidelines and protocols, participates in the development of future research studies.
In collaboration with the Program Coordinator, functions as a resource for all study issues.
In collaboration with the PI and Program Coordinator, develops and implements new single-site and multi-center research protocols including design, subject recruitment and scheduling, data collection systems, and institutional review board and FDA submissions.
In collaboration with the PI and Program Coordinator, directly supervises the activities of research staff, and is directly responsible for employment decisions. Develops, implements, and maintains an orientation and training program for all staff.
Serves as a liaison between the PI/team and sponsor (pharmaceutical companies and other outside vendors (i.e. CRO's)).
Implements and maintains quality assurance procedures and systems.
Coordinates lab activities such as mandatory training for confidentiality, infection control, radiation safety, and bio-safety.
Coordinates schedule of tests and procedures for research protocols. Responsible for overseeing the data collection process. Ensures integrity of patient data.
Contributes to the preparation of presentations and articles for publication.
Recruits and evaluates potential study patients. Per protocol instruction, conducts telephone interviews or schedules patients for study visits and screenings.
Interact with research subjects about study procedures, including study education, procedural instruction and follow-up. Serves as a liaison between patient and physician.
Performs study procedures, including the administration of questionnaires and sensory tests.
Collects and inputs data into the research study database. Works closely with the investigator to assist in the organization and basic statistical analysis of research data.
Maintains research records and databases as required for research purposes.
Answers any phone calls and inquiries regarding study protocol. Refers participants when appropriate to investigator or clinical staff.
Maintains inspection and calibration of research equipment.
All other duties as assigned.
QUALIFICATIONS: (MUST be realistic, neither overstated nor understated, and related to the essential functions of the job.)
B.S. or B.A. required
A minimum of one year of research experience required, 2 years in preferred
Supervisory and administrative experience, as well as experience with hospital reporting systems (Peoplesoft, Insight etc.) is preferred.
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:(MUST be realistic, neither overstated nor understated, and related to the essential functions of the job.)
Ability to work independently and display initiative to introduce innovations to study conduct and operations
Must have excellent interpersonal skills and the ability to supervise others
Must possess strong analytical skills and conceptual thinking
Excellent oral and written communication skills
Ability to prioritize tasks and set deadlines
High degree of computer literacy
Ability to identify potential problems and trouble-shoot solutions
Knowledge of clinical research protocols.
Excellent organizational skills and ability to prioritize a variety of tasks.
Careful attention to detail.
Ability to demonstrate professionalism and respect for subjects' rights and individual needs.
In collaboration with the PI and the Program Coordinator, directly supervises the activities of research staff, and is responsible for employment decisions. Develops, implements, and maintains an orientation and training program for all staff.
Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, ancestry, age, veteran status, disability unrelated to job requirements, genetic information, military service, or other protected status.