|Job Category||Trades & Technical|
|Position Type||Full Time|
|Application Deadline||November 30, 2021|
|Experience Required||5+ years|
The Clinical Affairs Team has an opportunity for a Clinical Research Associates Manager. The Clinical Research Associates Manager works with Clinical Affairs leadership in fostering growth and development of all Clinical Research Associates (CRAs) across the company. The Clinical Research Associates Manager will serve as a global clinical research training expert across the clinical organization through onboarding, ongoing training, support, mentoring and performance management to develop the skill sets and knowledge necessary to conduct clinical research studies.
Hold a leadership role, will manage direct reports and conduct ongoing review of Clinical Research Associate staff and project assignments to ensure adequate support to meet Divisional Clinical Research goals across multiple projects.
Interface with Clinical Project Teams, Clinical Research and Operational Managers who determine study objectives and resource needs. Responsible for the training, growth, development and performance management of CRAs in collaboration with the Clinical Affairs Research Teams.
Design, develop, execute and maintain the Clinical Affairs new CRA hire training program. Develop and/or update related SOPs and documents as appropriate.
Evaluate and ensure consistency of training plans for CRAs in consultation with Clinical Affairs management. Conduct ongoing review of CRA workforce and skills distribution to ensure adequate resources are available to meet departmental goals. Carry out individual resource and program baseline assessments with subsequent trainings and proficiency documented.
Devote time to hire, lead and develop CRA staff and as needed, directly carry out CRA activities for certain studies. Responsible to provide input for, train, support, and mentor other roles as required.
Ensure that clinical monitoring activities of the CRAs assigned teams are performed to the teams satisfaction, ensuring timely quality deliverables, in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements.
Leverage and implement clinical training best practices from other groups across Abbott.
Responsible for ensuring compliance with applicable Corporate and Divisional Policies and Procedures.
Responsible for implementing and maintaining the effectiveness of the Quality System. Identify quality issues related to clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, and quality assurance audit findings. Summarize findings and establish action plans for corrective actions.
Review Clinical Group processes and documents and identify/implement any improvements.
Provide subject matter expertise across in-house and external clinical activities.
Remain current on developments in the field of expertise including clinical and i-STAT product knowledge.
Identify and adapt to shifting priorities and competing demands.
Understand and comply with applicable EHS policies, procedures and guidelines.
Required Education and Experience
Knowledge of regulations and standards affecting IVDs (In Vitro Diagnostics) and Biologics.
Minimum Bachelors Degree in a discipline appropriate to a Clinical Research, Scientific, Medical, Technical or related field.
8+ years of experience as a CRA, direct Clinical Research experience, or an equivalent combination of education and work experience.
Proven ability/experience training CRAs and sites on relevant Clinical topics.
Experience directly supporting and training for clinical research or similar experience in a medical/scientific area.
Experience managing and training clinical research professionals within a team as well as in cross-functional development settings.
Ability to influence and lead both with and without direct authority.
Ability to clearly, concisely and accurately communicate (written and oral).
Ability to confidently speak in public, lead meetings and group discussions.
Ability to form and develop long-term strategic and professional relationships; display socially and professionally appropriate behavior.
Ability to work independently and in groups.
Demonstrated leadership skills, initiative, critical-thinking, and problem-solving skills.
Strong organization and time management skills.
Certification from the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA).
Medical Device/Diagnostics Clinical experience, understanding of the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage.
Experience using the i-STAT System.
Experience managing other clinical operations positions.
Willing and able to travel up to 10% of the time.