Senior Clinical Research Coordinator

GENERAL SUMMARY/ OVERVIEW STATEMENT:

Under the general supervision of the Principal Investigator (PI), the Senior Clinical Research Coordinator will provide clinical translational research assistance for clinical research protocols, including study management, study oversight and study implementation for research conducted as part of the Center for Neuroimaging of Aging and Neurodegenerative disorders program.

The Senior CRC will work independently to coordinate research studies and assist in data analysis and research reporting. The Sr. CRC will be responsible for research subject pre-screening, scheduling, enrollment, and execution of measurements. Further, he/she will help prepare and maintain human subject research (IRB) protocols and associated documentation, as well as oversee other junior CRC's on all regulatory submissions. A major component of the position is helping train and oversee other clinical and technical staff. The Sr. CRC will also have an opportunity to help the PI and other members of the team with developing new studies and analysis methods. The senior CRC will be responsible for assisting with communications with Sponsors/stakeholders, as needed.

The incumbent may assist the CRCII with the coordination of clinical research studies including the recruitment, assessment and retention of participants. The incumbent will assist in spreadsheet/database management, including maintaining appropriate protocols for data security, access, and quality assurance.

As part of the Senior Clinical Research Coordinator is also responsible for quality control of data acquisition and data analysis, reviews the work of trainees, coordinates lab activities, assists with the design of research protocols in conjunction with the PI, and assists with the development, improvement and implementation of standard operating procedures (SOPs). The SCRC also is responsible for the regulatory aspects of the lab studies, and is responsible for assisting with the development of IRB protocols, with filing all required necessary regulatory documentation and oversight of study team/monitoring of studies. The incumbent will assist with the training and supervision of new team members, including safety training, training on biosample processing, and training of all study related activities, including the use of Freezerworks and study related databases.

The incumbent should be able to identify problems or challenges and develop solutions. The incumbent will also be responsible for ensuring that study budgets are monitored at least monthly.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

* Co-ordinates recruitment and clinical measurements in conjunction with junior CRCs. This includes communicating with study subjects.
* Provides training and supervision of junior CRCs.
* Assists with recruiting and retaining patients for both observational and for clinical trials
* Works closely with study subjects, including patient/caregiver interviews, neuropsychological testing, assistance with obtaining vital signs, EGKs (electrocardiograms), brain imaging (which may include accompanying participants into the MRI/PET scanner), and phlebotomy - may involve occasional home visits.
* Maintain research data, patient files, regulatory binders and study databases, including RedCap, Freezerworks and other databases for sample/data inventorying.
* Documents and compiles clinical research data, schedules appointments and procedures, and maintains study databases
* Supervises and organizes general maintenance activities of lab (Freezer/temperature logs, maintenance of calibration of equipment and supplies, freezer defrosting)
* Assists with ordering supplies, keeping track of expenditures/invoicing for clinical trials
* Assists with internal monitoring of internal studies.
* Meets regularly with Principal Investigator to discuss assignments, projects, and administrative matters and to provide updates on their statuses.
* Attends training courses as identified
* Collects, organizes, analyzes, and summarizes acquired data, using scientific and statistical techniques.
* Prepares reports and presentations; presents at local, national and international meetings
* Prepares or participates in preparing manuscripts for publication.
* Organizes and/or drafts material for the preparation of research papers, manuscripts, or other documents for publication and/or presentation as appropriate
* Maintains accurate and timely records and databases
* Uses software programs to generate graphs and reports
* Obtains patient study data from medical records, etc.
* Conducts library searches
* Verifies accuracy of study forms and updates them per protocol
* Documents patient visits and procedures
* Assists with the preparation and maintenance of regulatory binders and QA/QC procedures
* Assists with interviewing study subjects
* Administers, scores, and evaluates study questionnaires
* Assists as needed with participant visits, including phlebotomy, EKGs etc.
* Provides basic explanation of study to subjects and in some cases obtains informed consent from subjects
* Assists with study regulatory submissions, including new and continuing studies
* Writes consent forms
* Verifies subject inclusion/exclusion criteria
* Performs administrative support duties as required
* Prepares for monitoring visits/responding to queries from monitoring visit
* Maintains research data, patient fields, regulatory binders, and study databases
* Performs data analysis and QA/QC data checks
* Develops and implement recruitment strategies
* Acts as a study resource for patients and families
* Monitors and evaluate lab and procedure data
* Contributes to protocol recommendations
* Assists with preparation of annual review and progress reports
* May assist PI to prepare complete study reports
* Adheres to MGH "Good-To-Go" policies and practices
* Assists with development of study related invoicing and ordering of supplies
* Maintains a neat work environment, including patient care areas, MR scan rooms, MR control rooms, and reading areas
* Monitors appropriate inventory and par levels of necessary supplies and communicates with Manager / Supervisor
* Performs other related duties as required/needed

SKILLS & COMPETENCIES REQUIRED:

* Ability to make independent effective decisions
* The ability to work with minimal supervision as well as part of an integrated research team
* Ability to supervise, lead a team
* Excellent judgment and ability to interpret information and protocol requirements
* Excellent organizational, oral and written communication skills
* Detail oriented, creative, able to maintain accurate records
* Careful attention to details
* Strong interpersonal skills
* Great organizational skills
* Excellent written and verbal communication skills, in order to work with staff who have various degrees of medical and technical experience
* High degree of computer literacy
* Working knowledge of clinical research protocols
* Ability to demonstrate respect and professionalism for subjects' rights and individual needs
* Ability to effectively multitask, prioritize multiple projects, and handle fluctuating priorities and deadlines
* High degree of professionalism, ability to interact with study subject and clinical collaborators
* Capable of handling confidential information with discretion
* Able to prioritize multiple tasks and handle fluctuating priorities and deadlines
* Ability to ask for help when needed
* Analytical skills and ability to resolve technical problems
* Ability to interpret acceptability of data results
* Ability to work with different database types
* Working knowledge of data management programs
* Knowledge of private and governmental insurance carrier rules and policies
* Ability to provide appropriate care to various age populations
* Ability to read, write, and effectively communicate in English

EDUCATION:

Bachelor's Degree required in Neuroscience, Psychology, Biology or related field.

EXPERIENCE:

Minimum of 3-5 years of directly related experience in biomedical research, clinical sciences, or related hospital administration is required.

WORKING CONDITIONS:

* May require ability to operate complex electronic equipment and instrumentation and perform quality control procedures on equipment required for completion of study assessments; ability to assist patients onto MR scan table and push table from prep room to exam room; must be able to lift and transfer patients to stretchers, lift/move MRI coils, etc. as needed.
* Flexible working hours are occasionally required due to limitations of recruitment of participants needed during occasional weekends. Clinical measurements may sometimes start as early as 7:30 AM.