Clinical Research Coordinator

The CRC I will work under the general supervision of Dr. Aleksandar Videnovic at the MGH Neurological Clinical Research Institute (NCRI). The coordinator will act as the primary coordinator for one to two research studies performed at the NCRI. Dr. Videnovic's research is centered on how sleep affects neurological outcomes and includes several clinical research projects in Parkinson's Disease (PD) and REM Sleep Behavior Disorder (RBD). Current projects include studies investigating biomarker discovery for synuclein-specific neurodegenerative disorders such as Parkinson's disease, projects centered on the sleep-wake cycles and circadian rhythms in PD and RBD, applications of light therapy aimed at improving sleep and fatigue in patients with PD for as well as several clinical research studies dedicated to neuroimaging and novel therapeutic drugs and devices. These studies require both individual and team efforts to complete. Dr. Videnovic frequently works with internal staff members and at other institutions, both inside and outside of Boston, in coordinating multi-center trials.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Administrative

• Provide support to the Principal Investigator (PI, Aleksandar Videnovic, MD MSc), co-investigators, and all other study collaborators
• Ensure regulatory requirements are met in accordance with GCP (Good Clinical Practice) and HIPAA (Protection of Human Research Subjects) standards
• Assist in maintenance of all study regulatory documents, including the preparation of annual IRB submissions, any needed IRB modifications, correspondence with the study sponsors, and physical regulatory binder
• Verify accuracy of study forms
• Regularly inform PI and study team of progress towards recruitment targets and milestones
• Assist the Principal Investigator in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials
• Perform other related duties as required (e.g., data entry, data checking/cleaning, literature reviews)
• Prepare data for analysis and data entry
• Work with PI to prepare and complete study reports

Operational:

• Provide a basic explanation of study details and in some cases obtain informed consent from subjects
• Assist in the administration of clinical assessments of the study subjects including but not limited to screening, evaluation and administration of online assessment to participants, coordination of biospecimen collection
• Assist with set up of sleep studies, actigraphy, and pupillometry
• Communicate frequently with MGH employees and sponsor representatives to ensure study visits are conducted appropriately
• Abstract medical records
• Contact participants regarding scheduling and data collection
• Assist with data collection, processing, entry, storage, and quality control for clinical research studies
• Coordinate study intervention sessions
• Participate in subject recruitment and assist with determining the suitability of research subjects
• Assist with developing and implementing recruitment strategies

Complete study visits that require EKG, phlebotomy, and vital signs collection

EDUCATION:

Bachelor's Degree

SKILLS AND COMPETENCIES:

• Ability to work well independently as well as with co-workers, peers, supervisors and patients
• Careful attention to detail and accuracy
• Ability to manage multiple tasks & priorities, and set deadlines
• Computer literacy
• Working knowledge of clinical research protocols
• Analytical skills and ability to resolve technical problems.
• Excellent communication and interpersonal skills.

LICENSES, CERTIFICATIONS AND/OR REGISTRATIONS:

CITI Certification, may be completed upon hire

• Strong organizational and data management skills.

EXPERIENCE:

Relevant coursework required. Prior experience working in a clinical research setting preferred.

WORKING CONDITIONS:

Office space, research clinic space, inpatient/outpatient research floor

Massachusetts General Hospital is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.