Clinical Research Coordinator I
If interested in this opportunity, please visit www.mghcareers.org and apply for JOB ID# 3194708
GENERAL SUMMARY/ OVERVIEW STATEMENT:
The research coordinator 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 two to three 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 the sleep-wake cycles and circadian rhythms in PD and RBD, a clinical trial 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 and actigraphy
- 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
WORKING CONDITIONS:
Office space, research clinic space, inpatient/outpatient research floor.
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
- 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.
- Strong organizational and data management skills.
LICENSES, CERTIFICATIONS, and/or REGISTRATIONS:
CITI certification, may be completed upon hire.
EDUCATION:
BA/BS Required.
EXPERIENCE:
Relevant coursework required. Prior experience working in a clinical research setting preferred.