Clinical Research Coordinator - Psychiatry
About The Position
This position implements, coordinates, and performs daily clinical research activities in accordance with approved protocols. The role involves assisting with assessing patient records to identify eligible participants, recruiting and enrolling patients, and ensuring the informed consent process complies with regulatory and sponsor requirements. The coordinator will educate patients and families about the study, schedule and coordinate patient care services, procedures, and testing, collect medical histories, and process biological samples. Additionally, the role includes administering and scoring diagnostic, psychological, or behavioral tests and questionnaires, monitoring patients for adverse reactions, documenting these responses, and notifying appropriate personnel and sponsors. The position also involves data collection, analysis, and contributing to the development of research protocols and publications.
Requirements
- Bachelor’s Degree in Biological Sciences, Health Sciences or medical field, or equivalent combination of education experience required.
- 0 years of relevant experience required.
Nice To Haves
- 2-4 years of relevant experience preferred.
Responsibilities
- Implements, coordinates and performs daily clinical research activities in accordance with approved protocols.
- Assists with assessing patient records to identify patients who are eligible to participate in specified clinical research protocols.
- Recruits, interviews and enrolls patients.
- Obtains informed consent and ensures consent process is administered in compliance to regulatory and sponsor requirements.
- Educates patients and families of purpose, goals, and processes of clinical study.
- Ensures initial and follow-up appointments are appropriately scheduled and fulfilled for participants to receive patient care services according to protocol.
- Coordinates scheduling and follow-through of surgeries, medical procedures, & other diagnostic testing.
- Collects and documents medical histories.
- Participates in the collection, processing & evaluation of biological samples.
- Administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires.
- Coordinates and documents care of patients.
- Assists with monitoring patients for adverse reactions to study treatment, procedure or medication and notifies appropriate clinical professional to evaluate patient response, identify status of complications, & provide appropriate level of care.
- Documents unfavorable responses and notifies research sponsors & applicable regulatory agencies.
- Participates in evaluating patients for compliance related to protocol.
- Assists with collecting, extracting, coding, and analyzing clinical research data.
- Compiles and enters clinical research data into study database.
- Generates reports and reviews to ensure validity of data.
- Assists with development of clinical research study database.
- Assists with writing sections of manuscripts, articles and other media for publication and presentation.
- Participates in activities to develop new research protocols and contributes to establishment of study goals to meet protocol requirements.
- Assists with planning and development of clinical study processes.
- Prepares and submits regulatory documents to applicable governing agency related to the conduct of human subject research.
- Supports activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations.
- Assists with coordinating and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors.
- Participates in planning, organizing and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors.
- Completes case report forms.
- Attends departmental meetings.
- Attends national professional and scientific conferences to continue professional development.
- Completes special projects as required.
- Collecting and organizing data.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
