Clinical Research Coordinator II
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GENERAL SUMMARY/ OVERVIEW STATEMENT:
Under supervision of the Associate Site Director of the Neurological Clinical Research Institute (NCRI), and working in collaboration with the multidisciplinary site team, the employee will act as a primary coordinator on research studies at the Neurological Clinical Research Institute (NCRI), which require both individual and team efforts to complete. Frequently works with staff members internal and at other institutions, both inside and outside of Boston, in coordinating multi-center trials. Often responsible for reporting and discussing the progress of a study during investigators’ meetings. Ensures that study materials reach subjects identified for recruitment and acts as a resource for individuals who may have questions or concerns. Coordinate patient flow in ALS clinic as indicated by healthcare providers.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Responsibilities and duties:
- Coordinates all activities of the subjects participating in the individual research studies such as scheduling patients for research study and collecting, organizing, and documenting the patient data from the visit.
- Maintains research data, subject files, regulatory documents and study databases.
- Assists professional staff with patient treatment according to study guidelines. For example, arranges specific blood draws; performs phlebotomy; processes fluids; records medical histories; provides patient education and conducts preps for specific procedures.
- Performs data analysis and QA/QC data checks.
- May develop systems for QA/QC.
- Data entry of information into study databases.
- Independently judges suitability of research subjects.
- Develops and implements recruitment strategies.
- Acts as study resource for patient and family.
- Administers/scores/evaluates study questionnaires.
- Able to complete study visits that require EKG, phlebotomy, and vital signs.
- Acts as liaison between Research Affairs and Unit.
- Files all documentation with IRB, including annual review.
- Recommends protocol changes and may assist with writing protocols and manuscripts.
- Works with PI to prepare complete study reports.
- Works cooperatively with study sponsor to ensure that good clinical practices are being followed and to schedule/conduct monitoring visits.
- Other job related duties as required.
ALS Clinic:
- Assist in patient flow for multidisciplinary ALS clinic
SKILLS & COMPETENCIES REQUIRED:
- Ability to work both very independently, and as a team member.
- High degree of computer literacy required.
- Ability to prioritize tasks and set deadlines.
- Analytical skills and ability to resolve technical problems.
- Excellent communication and interpersonal skills.
- Ability to interpret acceptability of data results.
- Strong organizational and data management skills.
EDUCATION:
Minimum Required:
Bachelor’s Degree
Equivalent Experience:
Minimum of 1-2 years of clinical research experience.