Clinical Research School of Medicine - Assistant Director - J. Morrissey
New Haven, CT 06510
About the Job
Clinical Research School of Medicine - Assistant Director
Oversee the clinical trial operation staff and operations that support the oncology disease group. Creates strategies and objectives the functional infrastructure related to productivity, compliance, communication and patient satisfaction.
Responsible for recruiting, hiring, performance evaluations, training, and day-to-day supervision of the clinical research professionals (clinical research managers, clinical trials project managers, data coordinators, clinical research coordinators, and clinical research nurses
. Establishes priorities with appropriate timelines for to ensure efficient and effective operations
Provide education and resources to staff, peers, faculty and oncology disease team leaders
. Partners with the CTO Quality and Education unit to ensure proper education and training of clinical research professionals (data coordinators, clinical research coordinators, clinical research nurses and
Develops a collaboration with the affiliated hospital system staff associated with therapy treatments of trial patients. Ensures full compliance of clinical research operations within the span of authority of the position. Acts as a liaison to the affiliated Hospital where Cancer patients are treated. Develops line of communication and creates care planning for preparedness of therapy and follow ups on any post treatment adverse reactions.
Guides the teams towards effective operational and SOP recommendations to achieve best Good Clinical Practices).
Reviews KPIs and creates reports regularly for data management. Utilizes the data to effectively monitor the process for protocol activation. Communicates the data trends of and effectively collaborates with sponsors.
Ensures timely performance of disease team portfolio from stage of protocol concept through obtaining open to accrual status.
Required Education and Experience
Masters Degree
8 years of clinical research experience including clinical trials research operations experience required including Clinical Research Coordinator role(s). Within those 8 years, 3 minimum must be people management experience.
Advanced level of clinical trials, regulatory and life cycle of study including all phases.
Good Clinical Practice and other Certifications such as CCRP (or willing to obtain within one year after employment)
Prior experience with conducting periodic reviews of the clinical trial portfolio
Prior Academic work environment highly preferred
Knowledge of immune cell therapy preferred
Experience coordinating audits of systems and practices
Data management experience to effectively monitor the process for protocol activation and regulatory compliance.
Highly effective communication skills with leadership and team building skills
Strong resource management, and proven effective problem solving skills
Ability to work in a fast-paced environment
Ability to resolve conflict while motivating others
Technology Skills: MS Word, Excel, RAVE, ONCore, Redcap
Full time Position M-F/ 2 days on site 3 remote-Located in Connecticut on site
$140-170+depending on experience.
INDI
Oversee the clinical trial operation staff and operations that support the oncology disease group. Creates strategies and objectives the functional infrastructure related to productivity, compliance, communication and patient satisfaction.
Responsible for recruiting, hiring, performance evaluations, training, and day-to-day supervision of the clinical research professionals (clinical research managers, clinical trials project managers, data coordinators, clinical research coordinators, and clinical research nurses
. Establishes priorities with appropriate timelines for to ensure efficient and effective operations
Provide education and resources to staff, peers, faculty and oncology disease team leaders
. Partners with the CTO Quality and Education unit to ensure proper education and training of clinical research professionals (data coordinators, clinical research coordinators, clinical research nurses and
Develops a collaboration with the affiliated hospital system staff associated with therapy treatments of trial patients. Ensures full compliance of clinical research operations within the span of authority of the position. Acts as a liaison to the affiliated Hospital where Cancer patients are treated. Develops line of communication and creates care planning for preparedness of therapy and follow ups on any post treatment adverse reactions.
Guides the teams towards effective operational and SOP recommendations to achieve best Good Clinical Practices).
Reviews KPIs and creates reports regularly for data management. Utilizes the data to effectively monitor the process for protocol activation. Communicates the data trends of and effectively collaborates with sponsors.
Ensures timely performance of disease team portfolio from stage of protocol concept through obtaining open to accrual status.
Required Education and Experience
Masters Degree
8 years of clinical research experience including clinical trials research operations experience required including Clinical Research Coordinator role(s). Within those 8 years, 3 minimum must be people management experience.
Advanced level of clinical trials, regulatory and life cycle of study including all phases.
Good Clinical Practice and other Certifications such as CCRP (or willing to obtain within one year after employment)
Prior experience with conducting periodic reviews of the clinical trial portfolio
Prior Academic work environment highly preferred
Knowledge of immune cell therapy preferred
Experience coordinating audits of systems and practices
Data management experience to effectively monitor the process for protocol activation and regulatory compliance.
Highly effective communication skills with leadership and team building skills
Strong resource management, and proven effective problem solving skills
Ability to work in a fast-paced environment
Ability to resolve conflict while motivating others
Technology Skills: MS Word, Excel, RAVE, ONCore, Redcap
Full time Position M-F/ 2 days on site 3 remote-Located in Connecticut on site
$140-170+depending on experience.
INDI
Source : J. Morrissey