Clinical Research Coor II R31383

at  Baystate Health

REQUIRED WORK EXPERIENCE:

1) 4-6 years of research experience

PREFERRED WORK EXPERIENCE:

1) None Listed

SKILLS AND COMPETENCIES:

1) Solid knowledge of physiologic disease states and medical terminology
2) Solid knowledge of clinical research data collection and clinical data report preparation
3) Proven ability to work in a data management setting in the accurate capture of patient data
4) Holds specialty certification in clinical research through an approved accrediting organization or college/graduate program
Within one year of eligibility must obtain Certified Clinical Research Professional – Association of Clinical Research Professionals

EDUCATION:

Bachelor of Science, GED or HiSET (Required)

1) Works under limited supervision. Supervisor available to handle most unusual situations and review progress of work
2) Conducts study tasks which are moderately complex to complex in accordance with established protocols or guidelines. Follows established guidelines in the review and collection of clinical data. May conduct screening of patients for inclusion in study based on predetermined criteria.
3) Assists with/conducts informed consent process with PI/Sub-I available for questions. Assists with/conducts patient education regarding protocol and requirements. Assists with/conducts protocol evaluation and implementation planning.
4) Develops, prepares, submits and maintains regulatory documents. Creates and maintains study and patient files in a highly accurate and organized manner. May develop study specific source and site documentation.
5) Performs actual study tasks as appropriate to level of knowledge & training. Responsible for source documents and case report forms. Prepares submissions to sponsor. Notifies investigators and sponsors of problems or issues, checks on progress and well-being of research subjects and overall direction of the research study.
6) May have responsibility for study budget development in conjunction with SPA. May have responsibility for planning related to protocol analysis and implantation. May perform preliminary data analysis.