Clinical Research Coord., Sr.

GENERAL SUMMARY:

 A Senior Clinical Research Coordinator position is available in the Gupta Laboratory in the Department of Neurology at Massachusetts General Hospital and Harvard Medical School.  The laboratory performs NIH, industry, and foundation sponsored clinical studies aimed at developing digital technologies to facilitate early diagnosis of neurodegenerative diseases and transform clinical trial design.

We are looking for an individual who will work with the PI, Clinical Research coordinators, postdoctoral fellows, and external collaborators and funding agencies to catalyze existing and new studies and support overall operations of the lab. This role includes project management responsibility, independent running of clinical studies, administrative support for the lab, as well as engineering and data analysis support. Ability to work independently with accuracy and attention to detail are required.

 PRINCIPAL DUTIES AND RESPONSIBILITIES: 

 Key responsibilities will include:

 Project Management

• Oversight and collaborative support for participant recruitment, data collection, data entry, and data quality assurance across all clinical studies being performed in the lab
• Lead onboarding and training of Clinical Research coordinators to carry out study procedures according to protocol
• Act as a resource for regulatory submissions and regulatory document collection/review/approval
• Ensure targets are met for study start-up, participant recruitment, and enrollment. Monitor study progress and protocol compliance.
• Coordination of patient recruitment and data management, as well as tracking patient payments for participation in studies.

       Develop and implement programs to engage study participants, increase longitudinal retention in the study, and increase the diversity of study population. 

• Train, promote independence, and collaborate with Clinical Research coordinators.
• Have working knowledge of all studies and be able to conduct protocols when needed.

 Initiate and Run Clinical Studies

• Help design protocols, develop budgets, create regulatory documents, and interface with external stakeholders in the startup of new clinical studies.
• Design, maintain, and update case report forms and electronic data capture systems.
• Organize, maintain, and manage REDCap Clinical Research databases.
• Review of medical records to screen and identify potential research participants.
• Recruit, consent, and conduct study protocols.
• Generate participant-related study data, including but not limited to: administering clinical questionnaires; administering motor and cognitive testing; obtaining vital signs and other physical measurements; setting up and obtaining scalp EEG recordings; performing blood draws; processing and shipping blood samples.

 Manage Lab Operations

• Act as a liaison with Human Resources to hire new personnel for projects: assist with job postings, tracking applicants, and setting up interviews.
• Maintain and acquire equipment as needed in support of studies. Track incoming and outgoing shipments.
• Track expenses and organize invoices, prepare and submit expense reports, reconcile corporate credit card statements.
• Organize and maintain lab SOPs and other documentation.

       Prepare materials, including written summaries for internal and external communication (website, newsletters) and grant support (funding updates, progress reports, etc).

       Submit and track Insight agreements and MGB support tickets.

• Coordinate lab activities including laboratory and other group meetings.
• Help schedule meetings and manage PI's calendar.
• Maintain research lab space.
• Integrate new hardware into Neurobooth system, depending on background and interest.
• Evaluate and test new devices.
• Acquire existing open source datasets (e.g., UK Biobank, PPMI).
• Flexibly assist with additional lab operations.

SKILLS/ABILITIES/COMPETENCIES REQUIRED: 

• Ability to effectively communicate with many different people throughout the institution, including patients, doctors, researchers, data managers, grant administrators, etc.

       Ability to work independently and regularly seek feedback on job performance.

• Ability to establish priorities and balance demands of multiple projects to meet deadlines.
• Must be able to identify problems and develop solutions. 
• Knowledge of Clinical Research involving IRB and NIH regulatory responsibilities, and knowledge of good clinical practice guidelines.
• Ability to interact comfortably and respectfully with both adults and children in a medical research environment.
• Outstanding time management and organizational skills.
• Excellent attention to detail.
• Excellent written and verbal communication skills.
• Ability to maintain a detailed and well-organized record of research performed and results obtained.
• Computer literacy, including proficiency with Microsoft Office programs and operating systems: MS Word, MS Excel, MS PowerPoint, as well as the ability to learn new software applications (MATLAB, R). 

EDUCATION: 

Bachelor's Degree required. Master's preferred.

 EXPERIENCE:

Minimum of 3-5 years of directly related experience; Experience in the sciences and/or engineering preferred.  Experience with IRB preparation and research management functions.

 SUPERVISORY RESPONSIBILITY:

Supervise 3 Clinical Research coordinators

WORKING CONDITIONS: 

        Primarily office and clinic environment.