Clinical Research Coordinator Manager
Background
TrialSpark is a software and technology company based in NYC that helps accelerate the discovery of new drugs and medical treatments by reimagining the clinical trial process. We are building a network of our own clinical trial sites and are looking to hire a lead to oversee a team of Clinical Research Coordinators.
Job Description
The Clinical Research Coordinator Manager is responsible for recruiting, onboarding/training and overseeing, managing and performance management of TrialSpark's Senior CRCs and CRCs in executing their day-to-day responsibilities. The CRC Manager will also be responsible for collaborating across all TrialSpark functional teams to execute high quality clinical studies and for leading initiatives to seek, identify and execute on opportunities to improve TrialSpark’s clinical processes and the broader organization.
Core Responsibilities:
- Mentor and manage a team of clinical staff of varying experience levels for your assigned region
- Providing regional oversight of assigned staff to ensure proper adherence to TrialSpark policies and procedures
- Contributing to the delivery of clinical staff training and development programs
- Contributing to the design and delivery of team capacity management system
- Leading study teams in all aspects of clinical readiness, including study protocol education, study-specific training program development and implementation, internal monitoring and quality checks to ensure high operational quality
- Serving as a point person during study startup and initiation, including attending and actively participating in site initiation visits
- Reviewing and attaining fluency in study protocols, developing a deep understanding of the study background, design, purpose, investigational product, schedule of events, risks / benefits, inclusion / exclusion criteria and objectives / primary endpoints
- Performing regular performance evaluation and identifying opportunities for staff advancement and development
Relevant Experience
- 4+ years of experience as a CRN or CRC running industry-sponsored clinical trials, including 1+ year(s) as a lead CRN or CRC on a clinical trial spanning multiple sites
- 1+ year(s) of CRN or CRC managerial experience
- Clinical skills (e.g., venipuncture, vital signs, ECG, etc.)
- Research skills (e.g., certified rater, fluent in EDC systems, etc.)
- Advanced Cardiac Life Support (ACLS) or Basic Life Support (BLS) certification
- Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) CRC Certification
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.