Clinical Research Associate Manager – Permanent!

Job CategoryProfessional Consulting
Position TypeFull Time
Application Deadline November 30, 2021
Experience Required5+ years
Job DurationPermanent
Education RequiredBachelors

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.
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.
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.
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.

Required Education and Experience:
Knowledge of regulations and standards affecting IVDs (In Vitro Diagnostics) and Biologics.
Minimum Bachelor’s 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.

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 managing other clinical operations positions.

If you are interested in this position, please apply or send your resume to
[email protected]
Only qualified candidates may be contacted about this role.