Clinical Research Manager ** Temp-to-Perm

Overview:

Our client, is a leading, mission-driven healthcare organization dedicated to delivering high-quality, compassionate care through an integrated network of physicians and advanced clinical services in Southern California, seeks an accomplished Clinical Research Manager.

*** Candidate must be authorized to work in USA without requiring sponsorship ***

******************************************************************

*** Temp to Perm role ***

*** Location: Anaheim, CA 92805

*** Duration: 13 weeks contract w/ possibility of extension or conversion to FTE role

Notes:

• Applicants who are not looking for a permanent role will not be accepted.
• Required upon hire: ACRP or SOCRA certification, or another Clinical Research Certification.

Description:

• Under the supervision of the Director, the Manager of Clinical Research is responsible for assuring the strategic vision, directions and operations of the clinical research finance department are implemented and adhered to by all staff.
• Responsible for oversight of the day-to-day operations of the clinical research finance team.
• Responsibilities include compliance with regulations and assuring good communication between the various ministries, stakeholders, and leadership.
• Assists in developing, implementing, and maintaining policies and procedures.
• Assists in providing on-going formal and informal training for research staff.
• Manage Human Resource functions of the Department including recruitment, hiring, career development, performance evaluations, disciplinary actions, and day to day Human Resource functions.
• Responsible for overseeing the development of research contracting and budgeting standards.
• Directs the negotiation of contracts for clinical trials and determination of internal costs and development of internal budget for negotiations of sponsored and investigator initiated clinical trials in compliance with applicable state and federal laws and regulations, especially Medicare and Stark Law.
• Lead the development and implementation of study builds in the clinical trial management system (CTMS).
• Oversee HR functions for the finance team, including recruitment, hiring, performance evaluations, disciplinary actions, career development, and daily operations.
• Collaborate with leadership to develop and implement strategic plans, allocate resources to support growth, and foster professional development and shared decision-making among staff.
• Facilitate transparent communication and collaboration with clinical research programs, Clinical Program Services, and other key stakeholders regarding operations, contracts, budgets, finance, and CTMS.
• Build and maintain collaborative relationships across departments, hospital leadership, physician investigators, and external research partners.
• Lead team responsible for internal budget development and negotiations, ensuring compliance with FMV, Medicare guidelines, and state laws.
• Manage department budgets, financial tracking, and month-end accounting processes.
• Direct contract negotiation strategies with clinical trial sponsors.
• Provide expertise in developing standard clinical trial agreements and collaborate with Legal Affairs to align contracts with site needs.
• Manage and lead the month end accounting process, reviewing for quality assurance, and accuracy and addressing areas of concern.
• Supervise post-award financial management, including invoicing, revenue accrual, vendor payments, and financial reporting.
• Ensure accurate billing, coding, and compliance with Medicare research funding rules.
• Lead the development and implementation of CTMS, aligning system functionality with clinical protocols, contract terms, and financial workflows.
• Balance technology investment with compliance and ROI.
• Provides resources and experiences to team to interpret clinical trial protocols, contracts, and budgets into study specific builds, as well as allowing for patient management, and the AR and AP activities of all clinical trials.
• Ensure adherence to federal regulations and system policies in clinical trials.
• Develop and maintain QA processes, data controls, and compliance standards to protect organizational interests.
• Knowledgeable of Medicare research funding rules and regulations and ensures appropriate billing and coding of patient services to correct research account.
• Aid in developing standard operating procedures and policies to improve departmental efficiency and performance.
• Identify and lead quality improvement initiatives.
• Institutes controls to assure accuracy, completeness, and confidentiality of research data. Identifies, facilitates, and coordinates quality improvement opportunities; develops local QA process to address areas of need.
• Demonstrate deep understanding of the clinical trial lifecycle, including feasibility, budgeting, contract alignment, reporting, and operational implementation.
• Advanced understanding and working knowledge of accounting platforms, research grant management, and clinical trial platforms.
• Develop and implement strategies to increase revenue and accelerate project timelines, ensuring competitiveness and goal achievement.

Qualifications:

• Bachelor's Degree Required. Master's Degree Preferred.
• 7 years of Clinical research experience required.
• 5 years in management or supervision of clinical trials required.
• 5 years’ experience in clinical research finance required.
• Experience in managing data collection, reporting, outcomes, quality improvement, standards/pathways required.
• Experience in meeting FDA (GCP, ICH guidelines), as well as other Federal, State and Local regulations surrounding human research required.
• Experience with working with Pharmaceutical and FDA agency representatives required.
• Computer literate to include advanced level proficiency in Microsoft Office Programs (Word, Excel, Access, and PowerPoint), E-mail and Internet.
• Thorough knowledge and understanding of HIPPA, GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.
• Extensive knowledge of DHHS, FDA, NCI, NIH, OHRP and other relevant regulations concerning research and compliance.
• Knowledgeable of principles of accounting and contract law affecting clinical trials.
• Ability to successfully budget and negotiate industry contracts for sponsored clinical trials.
• Highly organized and attentive to details, problem solving abilities and the ability to work with minimal supervision.
• Highly motivated and able to take initiative.
• Ability to prioritize, organize, plan, and implement as well as handle multiple projects/problems simultaneously within a fast-paced environment; able to collect and manage large amount of data and maintain databases; communicate progress, challenges, and results effectively.
• Knowledge of operations, including human resources, budget management, and workflow planning.
• Ability to plan, chair, document, and follow-up on administrative and related meetings.
• Ability to work independently and with minimal supervision.
• Ability to be flexible, multitask and switch priorities as well as work comfortably in a deadline driven environment.
• Communicates well with physicians, patients, sponsors, and staff on interpersonal and technical levels, both verbally and in writing; demonstrates high integrity and maintains confidentiality of all information.
• Interact favorably with people by phone and in person and work effectively as part of a team.
• Demonstrate communication, leadership, and team building skills; evidence of this should include dealing well with people, effective problem solving, appropriately confronting issues, motivating others as individuals and as groups, planning, organizing, and directing the activities of others.
• Excellent written/verbal communication skills to effectively interact with all levels of management, departments, and users.

***************************************************************

I'd love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you.

Satwinder “Sat” Singh

Lead Technical Recruiter

Company Overview:

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.