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Lead Clinical Research Coordinator

Boston, MA, United States

Overview:

We are recruiting an experienced and highly motivated individual with strong research management skills to serve as a Lead Clinical Research Coordinator (CRC) for a grant funded position in the lab. The CRC will be primarily responsible for the day-to-day study operations, including management and oversight of recruitment and data collection activities, preparation and management of IRB actions, data quality assurance, preparation of agendas for team meetings, management of regulatory documents, communication and reporting to PI, study team & funding source. These responsibilities require close interaction with the clinical teams in the SRN Inpatient and Outpatient Brain Injury Programs. The CRC will work under the supervision of the Principal Investigator and Program Manager.

This CRC will primarily be involved with a study entitled, "Resiliency after Acquired Brain Injury: Defining and Enhancing Biopsychosocial Function," which aims to characterize the psychological and neurobiological features of resilience that affect recovery in persons who have experienced moderate to severe acquired brain injury. In addition to this study, the CRC will support the Program Manager in operational duties across the lab, including finances, regulatory compliance, and communications with internal and external partners.

The mission of the Spaulding Neurorehabilitation Laboratory (SNL), directed by Dr. Joseph T. Giacino, Professor of Physical Medicine and Rehabilitation at Harvard Medical School, is to improve the precision of diagnostic and prognostic assessment methods, develop more effective treatment interventions and improve quality of life for persons with acquired brain injury. Areas of focus include instrument development, novel approaches to multidimensional outcome assessment, neuromodulation and knowledge translation.

Examples of SNL projects include:

* The Traumatic Brain Injury Model System (TBIMS) Program, funded by the National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR) conducts longitudinal outcome research in persons with moderate to severe traumatic brain injury and manages the largest and longest-running longitudinal TBI database in the world, which currently includes more than 18,000 participants and over 70,000 follow-up visits.

* The Transforming Research and Clinical Knowledge in Traumatic Brain Injury Study (TRACK-TBI), comprised of 18 US Level 1 Trauma Centers, has accrued the largest and most comprehensive precision natural history study of TBI ever conducted in the US and enrolled more than 2900 patients with TBI across the age (0-100 years) and injury spectrum from concussion to coma, along with orthopedic and friend control groups.

* More information about the SNL can be reviewed at https://www.neurorehablab.org/.

Specific responsibilities may include:

Data Collection & Management

* Medical record abstraction

* Conducting self-report and standardized interviews in-person and via telephone with research participants and/or their legally authorized representative

* Recruitment, enrollment, and study milestone tracking

* Data entry and extraction

* Support other CRCs in their data collection & management responsibilities

Performance reporting

* Quarterly and annual reports to funding agencies

* Audit preparation and follow-up

* Internal quality assurance reporting

IRB

* New applications

* Amendments

* Continuing reviews

Meetings/scheduling

* Arrangements and scheduling

* Preparation of agendas and minutes

Training Responsibilities

* Completion of required personal certifications and renewals

* Training and overseeing new hires, including student externs, in informed consent procedures, structured interviews, and self-report measures

Community Relations

* Assist with preparation of newsletters

* Prepare recruitment materials

* Update lab website

* Participate in lab-sponsored community events

Scholarly Activities

* Conduct literature reviews

* Assist with manuscript preparation

* Develop PowerPoint presentations and other dissemination media

General Administrative

* Supports program manager in facilitating weekly lab meetings, tracking of regulatory compliance activities, maintenance of the laboratory spaces, and development and maintenance of lab-wide manuals of operating procedures

Qualifications:

Education/Degree

Bachelor's degree required. Master's degree preferred.

Experience

Required

* Training background in clinical science or public health

* Prior experience as a clinical research coordinator

* Familiarity with IRB policies and procedures

Preferred

* Training/experience in neurologic diseases and/or rehabilitation

* Fiscal/budget management

* Database development/management

Required Skills

* High level time management and organization skills

* Excellent written and verbal communication skills

* Administrative skills to meet regulatory requirements

* Knowledge of current and developing clinical research trends

* Ability to meet the requirements of varying funding sources

* Sound interpersonal skills and the ability to supervise others

* Ability to work independently and display initiative to introduce innovations to research study

* Ability to identify problems and develop solutions

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