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Clinical Research School of Medicine - Assistant Director
55 Church St. New Haven, CT 06510 US
Job Description
• 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
Master’s 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
Meet Your Recruiter
Krisha Morander, CPC
Vice President, Healthcare & Information Technology
Krisha's journey in the professional world has been nothing short of remarkable. Starting her career after completing her college education, she ventured into the realms of Commercial Art and Marketing, honing her creative and strategic skills. However, her path took a significant turn as she discovered her calling in the field of Recruitment.
Growing up in a close-knit, caring family where everyone played a vital role in supporting each other, including the care of elderly parents, Krisha's deep-rooted passion for healthcare began to flourish. She redirected her focus towards assisting job seekers in finding meaningful careers in healthcare that could make a genuine difference in the lives of others.
With an impressive 31-year career in the Staffing Industry, Krisha's expertise spans various domains. Initially, she dedicated herself to agency firm work, with a primary focus on healthcare and marketing communications. Her journey took a pivotal turn in 2004 when she joined J Morrissey. Here, she embraced Direct Hire Healthcare recruitment as her specialization.
In 2010, Krisha's entrepreneurial spirit led her to create the Information Technology division within the organization. Her dedication and exceptional performance in this role earned her the prestigious title of Vice President. She continues to pursue her passion for recruiting top-tier talent and nurturing new client relationships. Krisha also takes an active role in training and mentoring new staff, instilling in them the best practices and the art of meaningful interviewing.
Krisha's Direct Hire Recruitment Specialties encompass both Healthcare, spanning clinical and non-clinical roles, and Information Technology, from junior-level positions to the highest echelons of C-Suite leadership.
Outside of her illustrious career, Krisha finds solace and inspiration in the world of watercolor painting. Her creative spirit knows no bounds.
In her personal life, Krisha shares a blissful marriage of 36 years, a testament to her commitment and enduring love. Together with her loving partner, she is proud to be the parent of two wonderful children, completing her fulfilling life journey.