Manager, Clinical Research Center Operations - Physician Practice

Manager Of Clinical Research Center Operations

Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community.

Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.

The Manager of Clinical Research Center Operations is responsible for Clinical Research Center Staff and other clinical support staff for all areas of Clinical Research across the Hackensack Meridian Health (HMH) network, ensuring compliance of all research studies and regulations.

A day in the life of a Manager of Clinical Research Center Operations at Hackensack Meridian Health includes :

• Manages Clinical Research staff and other clinical trial support staff, assigns schedules and makes operational decisions regarding staffing levels, workflow, and coverage for clinical trials research.
• Monitors and measures staff performance regularly and performs all evaluations.
• Interprets, supports and communicates policies, standards and procedures of the research process.
• Provides training of all new team members and assigns coverage for multiple research locations.
• Ensures that staffing on clinical trials is maintained at agreed upon service level in study protocol, in study budget and in accordance with SOPs to ensure cost effective use of Department resources.
• Manages hiring and payroll processes for HMHN Research team members in PeopleSoft HR system.
• Evaluates, develops and implements corrective action plans with research team members.
• In the absence of the director, leads research department weekly meetings and attends monthly meetings for all areas that Research supports.
• Ensures that team members are in full compliance with written protocols, SOPs, HMH policy and GCP, IRB policies, FDA regulations, HMHN Continuing Education and license requirements and Joint Commission rules.
• Protocol management for Phase I, II, III and IV study operations for the network research activity and interacts with ancillary Medical Center staff (Pharmacy, Laboratory, Infusion Center, etc) for the proper execution of a protocol.
• Liaison with Principal Investigators and leads study feasibility and provides support to new PIs beginning the research process.
• Meets with FDA auditors and sponsor representatives as required.
• Reviews correspondences from sponsors and regulatory authorities (monitoring follow up letters, quality assurance) to ensure all outstanding items are resolved.
• Works closely with staff and department to ensure corrective action plans for audit deficiencies are resolved.
• Works collaboratively with the Research Budget / Contracts office to ensure that research related fees are appropriately captured and that trial agreements are fully executed.
• Works on special projects for Research department quality assurance, regulatory affairs and education sections, including review and submission of Standard Operating Procedures.
• Attends educational offerings and conferences to stay current on best practices
• Other duties and / or projects as assigned.
• Adheres to HMH Organizational competencies and standards of behavior.

Education, Knowledge, Skills and Abilities Required :

Education, Knowledge, Skills and Abilities Preferred :

If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!

Compensation Starting at $111,924.80 Annually HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package. The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to :

Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts. In addition to our compensation for full-time and part-time (20+ hours / week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.

Hackensack Meridian Health (HMH) is an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.