Location: Boston,MA, USA
Overview
The Rosas Lab's Clinical Translational Research Program is hiring a highly motivated individual to help manage our clinical programs. Receiving very general direction from the Principal Investigator, the incumbent will oversee and manage the Down syndrome and Huntington Disease clinical translational programs and clinical trials research. The position requires a comprehensive and detailed understanding of Institutional Review Board (IRB) and clinical research procedures, as well as management skills with a high degree of initiative and independent judgment. The incumbent should demonstrate basic competency for caring for patients with cognitive and behavioral impairment, including impaired decision making capacity. The incumbent should also possess excellent phlebotomy/IV placement skills, prior experience in clinical research and in working with vulnerable populations.
Principal Duties
* Manage all aspects of the clinical research protocol, including all clinical and neuropsychological and biomarker assessments; taining and supervision of staff; participates in clinical visits; ensures that clinical databases are kept up to date.
* Manage all study related documents including new Institutional Review Board protocols and continuing reviews, Investigational New Drug applications, and other regulatory documents related to the clinical protocols.
* Interpret and apply GCP and IRB policies to support research compliance.
* Coordinate training program for, and oversight of, clinical coordinators/staff and manage assessment of competency for lab members with regards to data acquisition and analysis.
* In charge of establishing and monitoring safe, compassionate and excellent practices clinical research, which aims to provide the highest quality environment for performing patient-oriented research with patients suffering from serious neurologic and psychiatric illnesses while maintaining the safest practice standards.
* Assist in the preparation for Clinical Trial Monitoring visits and internal/external reviews.
* Establish standards for the delivery of research procedures; act as a role model by providing excellent service to internal and external contacts.
* Develop, evaluate and standardize operating procedures (SOPs) and effectively troubleshoots and resolves issues.
* Supervise and manage staff
* Provide a resource for patients and staff
* Recruit participants for research protocols
* Responsible for clinical study assessments, phlebotomy, infusions, EKGs, other clinical assessments as required
* Attends weekly clinics and reports study progress as appropriate.
Regulatory
* Provide oversight and advise Clinical Research staff
* Draw on previous clinical research related experience and knowledge of FDA, OHRP regulations as well as GCP and NIH guidelines, participate in the design and implementation of new proposals and projects, as appropriate
* Assist with IND applications, if needed
* Plan and conduct project team meetings
* Participate in planning and implementing training opportunities/programs/development of standard operating procedures
* Lead in the timely execution of high quality clinical research projects leveraging knowledge, expertise, and risk mitigation.
* Build effective, high performance teams via expert communication, decisiveness, prior experience and technical expertise
* Lead all activities relating to formal communication with regulatory agencies (FDA, Health Canada, etc), funding agencies (NIH, industry sponsors, foundations, etc) and safety monitoring boards
* Troubleshoot study/portfolio related issues and escalate, as appropriate
* Assist with generation of reports and preliminary data analyses.
* Take on additional tasks and responsibilities, as requested.
Skills/Abilities
* Excellent written and verbal communication skills.
* Advanced time management and analytical skills.
* Ability to organize information.
* Ability to handle sensitive information with absolute confidentiality.
* Knowledge of Institutional Review Board applications.
* Working knowledge of software applications including Microsoft Word, Excel, Power Point, RedCap, EPIC.
* Ability to make decisions independently and/or to escalate issues as needed.
* Ability to seek information and second opinion when needed.
* Ability to problem-solve, suggest and implement solutions, as needed.
* Dependability, perseverance, flexibility and skills as a team player.
* Ability to multitask in a challenging environment.
* Excellent communication skills.
* Leadership. Role Model.
Education
* BS degree in health related field.
* Nursing degree with nursing licensure preferred.
Experience
* Minimum of 2-3 years of clinical research experience, including management of all stages of interventional drug trials from study start up though data lock and study close out.
Supervisory Responsibility
* Supervise day to day operations of all study staff. Responsible for training and supervision of new staff.
* Liaising with laboratory personnel.
Working Conditions
* Day to day operations are performed at the Charlestown Navy Yard, outpatient clinics at MGH and McLean and inpatient units at MGH.
* This is a fully onsite position.