- Coordinates the implementation, both internally and externally, of sponsored clinical research studies.
- Initiates and maintains recruitment contact with study participants. Responsible for screening applicants, ensuring they meet appropriate criteria, and makes independent judgement as to the suitability of their participation. May be required to perform clinical tests such as phlebotomy, ECGs, etc.
- Working in concert with Principal Investigator and/or Research Manager, and experienced coordinators to develop and implement patient recruitment strategies.
- Working in conjunction with RCNet Manager and CCI Administrative Director on miscellaneous administrative duties integral to CCI/RCNet programs.
- Interacts with patients/subjects with regard to the study, including patient education, procedural instruction, follow-up. Serves as a liaison between patient and physician, and as a resource for participants and their families.
- Responsible for collection of data and maintaining patient information databases for the study. 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.
- In conjunction with Research Manager completed regulatory paperwork for institutional review board approval.
- Responsible for mailing various study information or packets to study participants.
- Answers phone calls and inquires regarding the study protocol. Refers participants when appropriate to principal and co-investigators.
- Communicates regularly with the PI(s) about all aspects of the research trial.
- Responsible for collection data and maintaining patient information databases for the study. 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.
- In conjunction with Research Manager completed regulatory paperwork for institutional review board approval.
- Responsible for mailing various study information or packets to study participants.
- Answers phone calls and inquires regarding the study protocol. Refers participants when appropriate to principal and co-investigators.
- Communicates regularly with the PI(s) about all aspects of the research trial.
- BS OR BA required, equivalent experience or research certification acceptable as well
- Previous laboratory, research, or clinical work preferred. Some 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.
- Ability to work independently.
- Excellent interpersonal skills are required for working with the study participants.
- Good oral and written communication skills.
- Analytical skills and the ability to resolve technical or research problems and issues and to interpret the acceptability of data results.
- High degree of computer literacy.
- 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.
- Knowledge of data management programs.
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Clinical Research Assistant, Center for Clinical Investigation, Hybrid - Boston, United States - Partners Healthcare System
Description
GENERAL SUMMARY/ OVERVIEW STATEMENT:
Working under general supervision from a manager, lead coordinator or Principal Investigator, provides support to clinical research studies.
May be responsible for the following activities:
screening and scheduling potential participants for clinical trials, developing and implementing patient recruitment strategies, performing applicable clinical tests such as phlebotomy, ECGs, etc, maintaining and updating data generated by the study, assisting in the team effort of making judgment of suitability of potential participants for clinical trials, assorted administrative work on patient documents, folders and research projects.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
QUALIFICATIONS:
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
WORKING CONDITIONS:
General fast paced office, clinical, and laboratory environment. Candidate may be required to work in multiple locations within the hospital. The candidate will be required to handle biological specimens and follow universal precautions for blood and pathogen protection. He/she will also handle various pieces of electronic equipment. Some heavy lifting and/or transporting may be necessary from time to time.
