Clinical Research Coordinator II - Psychiatry

Clinical Research Coordinator II - Psychiatry:

This position will assist the Principal Investigator (PI) in the planning, implementation, and coordination of clinical research studies focused on neuropsychiatric and neurodegenerative disorders, including studies involving cognitive and psychiatric assessment, biomarker collection, digital health technologies, EEG, and home-based noninvasive brain stimulation interventions, including tDCS and tACS. The Clinical Research Coordinator II will support participant recruitment, study operations, data collection, regulatory compliance, and participant retention across clinic-based and remote research settings, including administration of cognitive, behavioral, functional, and patient-reported outcome measures, as well as support for device setup, remote monitoring, adherence tracking, and troubleshooting. Preferred experience includes administering cognitive, behavioral, neuropsychological, functional, and patient-reported outcome measures; telehealth or home-based clinical research; and methods such as noninvasive brain stimulation/neuromodulation, EEG, neuroimaging, digital health technologies, or biomarker-based research.​

Principal Investigator: Davide B. Cappon, MS, PhD

Job Profile Summary 

​This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Programs and Projects duties: Supports the development of new products and innovation.  Includes Clinical roles focused on research projects.  Positions in this family perform basic, translational, and/or clinical research towards solving a specific problem for an entity or community.A professional individual contributor role that may direct the work of otherlower level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typicallyacquired through advanced education.   An entry level role that applies broad theoretical job knowledge typically obtained through advanced education. May require the followingproficiency:  work is closely supervised, problems faced are not typically difficult or complex, and explains facts, policies and practices related to job area. 

Job Overview 

This position willassist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned. 

Job Description 

Minimum Qualifications: 

1.Bachelor’s degreeOR High School Diploma or equivalentAND Four (4) years of related experience. 

2.Basic Life Support (BLS) certification may berequired based on specific role requirements. 

3. Two (2) years in research related activities. 

Preferred Qualifications: 

1. Five (5) years inresearch related activities. 

2.Previous experience in clinical trials. 

Duties and Responsibilities: Theduties and responsibilities listedbeloware intended to describe the general nature of work and are not intended to be an all-inclusive list. Other dutiesand responsibilitiesmay be assigned. 

1. Responsible forassisting in the recruitment of study participants.  

2.Organizes strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings asrequired. 

3.Completes follow up with study participants in prescribed settings asrequired. 

4.Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Formsin accordance with best practice methods.  

5.Complies with all institutional policies and government regulationspertaining to humansubjects’ protections.  

6.Responsible forassisting with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements,submitting documents for review, adverse event reporting and annual reviews. 

7.Performs basic laboratory activities as needed. 

8.Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines. 

9.Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor. 

10.Arranges necessary tests and proceduresin accordance with protocol requirements and reports results to the investigator. 

11.Performs necessary tests as needed and asappropriate to level of training such as EKGs, Walk tests,etc. 

12.Organizes andparticipates in site visits with the study sponsor to review completeness and accuracy of study documentation. 

13.Maintains inventory of all study supplies. 

14.Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements. 

15.Reviews all eligibility and ineligibility criteria in the patient’s record. 

16.Verifies information with the physician. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form. 

17.Conducts a QC check of completed CRFs prior to submission for data entry. 

18.Coordinates resolution of all data queries. 

19.Completes data entry aswarranted. 

20.Maintains regulatory binders, case report forms, source documents, and other study documents.  

21.Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board. 

Physical Requirements:  

1. Typical clinical and administrative office setting. 

Skills & Abilities: 

1.High degree of organizational talents, data collection and analysis skills. 

2.Requires meticulous attention to detail. 

3.Excellent computer skills including word processing. 

4.Ability to prioritize quickly and appropriately. 

5.Excellent communication and interpersonal skills. 

6.Systematic record-keeping.