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Associate Director, Clinical Monitoring

Cognitive Research Corporation
Remote
Full-time

Location

Remote

Benefits
Pulled from the full job description

  • 401(k)
  • Dental insurance
  • Employee assistance program
  • Flexible spending account
  • Health insurance
  • Life insurance
  • Paid time off

Full job description

About Us:

Cognitive Research Corporation (CRC) is a privately held clinical research organization specializing in CNS research. CRC was incorporated in 2006 and has grown to a team of 100. We are a full-service CRO providing comprehensive clinical operations, data management and statistical analysis services. CRC brings to our clients, industry recognized expertise in cognitive assessment, driving assessment, evaluation of movement disorders, and application of neurological and psychiatric rating scales. We have a truly exceptional Biostatistics team and a robust network of Clinical Investigators who support Phase 1 through Phase 4 clinical trials.

CRC has contributed to the program design, drug development and registration of numerous FDA and globally approved medicines.

We are committed to our employees and proactively support the professional growth of individuals. We are a diverse group of professionals that proactively foster a positive workplace culture to work, learn and contribute to bringing medicines to patients.

Position Summary:

The Associate Director is responsible for the oversight, growth, and development of Clinical Research Associates (CRAs) and will work with Clinical leadership to develop site monitoring procedures (SOPs) and tools for use in the selection, initiation, and ongoing management of clinical trial sites. The Associate Director will be responsible for CRA performance, resource allocation, and line management. Directs the growth and development of a group of CRAs and/or CTMs. Expected to manage site related matters, including start-up and activation, clinical monitoring activities, overall data quality and metric analysis, and essential document collection in collaboration with Clinical Program Managers. Trains, manages and develops CRAs and/or CTMs to ensure clinical trials are conducted in compliance with pertinent regulations and study documents.

Key Responsibilities:

  • Strategic leadership of CRAs and/or CTMs (employees and contractors) including administrative oversight, professional development, performance management and mentoring/counseling of staff. Establish and manage staff through the development and tracking of goals that increase knowledge and skill level.
  • Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metrics compliance, and development of contingency plans, among others.
  • Provides guidance and oversight to the clinical monitoring team (CRAs and/or CTMs) to ensure adherence to project scope, SOPs, timelines, and budget requirements.
  • Work closely with Clinical Program Managers and Clinical leadership to ensure that all studies are appropriately resourced from a start-up, monitoring and study support standpoint. Identifies clinical monitoring resources and directs ongoing project allocation & utilization.
  • Responsible for compliance and utilization standards - ensuring CRAs and/or CTMs achieve role specific KPIs and meet project deliverables.
  • Responsible for hiring, training and retaining a diverse group of skilled CRAs and/or CTMs ensuring compliance with pertinent regulations. Supports recruitment through conduct of initial screening, phone and face-to-face interviews of potential CRAs and/or CTMs.
  • Develops and implements programs to train and mentor new CRAs and/or CTMs, as well as providing ongoing education and mentorship to direct reports.
  • Develops direct reports snd proactively identifies and addresses any areas of concern, providing development opportunities to team members and as needed, escalating performance and/or personnel issues.
  • Works with the Clinical Leadership to ensure that all CAPAs are adequately developed, reviewed and implemented.
  • Review of time and expenses of direct reports.
  • Functions as point of escalation for clinical monitoring issues. Oversees progress of monitoring teams supporting clinical projects. Ensures individual and team tasks are completed according to requirements per Sponsor/Customer expectations and contract.
  • Takes a lead role in management of customer relationships. Provides support to Business Development to facilitiate new project awards during bid defense process, and expert guidance where needed.
  • Assures compliance to corporate Standard Operating Procedures (SOPs), ICH GCPs and other regulatory requirements through active performance management, quality control checks and project metrics analysis.
  • Assures timely submission of clinical project metrics.
  • Contributes to the development, revision, and improvement of current work processes. Responsible for development and revisions to company SOPs related to clinical monitoring activities.
  • Contributes to company-level initiatives as they relate to clinical monitoring and ensures department needs are represented.
  • Facilitates collaborative environment through effective team development and leadership.

Qualifications:

  • Bachelor’s degree in a life sciences, nursing degree or equivalent related field of study and 8 years previous clinical monitoring experience and regulatory compliance required; Master’s degree in relavent field preferred
  • 3-5 years of direct line management, team development and experience in a cross-functional environment; ability to build and lead an effective team in a CRO environment.
  • 3 years demonstrated experience field monitoring experience gained with a CRO; experience supporting CNS clinical studies preferred.
  • Direct experience in the selection and start-up of clinical sites
  • Experience working in a team environment under time and resource pressures
  • Proficient in training and coaching others; ability to mentor and teach others at every level
  • Strong leadership and management skills.
  • Ability to manage workload, staff allocation, quality, and project budgets - understanding of the principles of project management, including finances
  • Knowledge clinical trial management in fast paced environment.
  • Expert knowledge of and experience with GCP/ICH guidelined and other appliction regulations.
  • Proficiency with MS Office Suite, including Word, Excel etc...
  • Ability to negotiate effectively, resolve conflicts and build consensus
  • Excellent communication skills, written and verbal
  • Effective writing and verbal skills, English language.
  • Meticulous attention to detail.
  • Time management and ability to prioritize.

Job Type: Full-time

Benefits:

  • 401(k)
  • Dental insurance
  • Employee assistance program
  • Flexible spending account
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Experience level:

  • 5 years

Schedule:

  • Monday to Friday

Education:

  • Bachelor's (Required)

Experience:

  • Clinical Monitoring: 5 years (Preferred)
  • CRA Management: 3 years (Preferred)

Work Location: Remote