WellNow Clinical Research is a Phase II-IV clinical research organization that operates within the acute care space. We are highly experienced and prioritize protocol compliance, data integrity, and patient safety. WellNow Research is a leading site network delivering high quality clinical research and data to sponsors, and high quality, compassionate care to research participants. 

JOB SUMMARY:

The Clinical Trials Manager is responsible for the overall operational activities for the implementation and conduct of clinical trials at multiple sites. The Clinical Trials Manager supervises and evaluates work activities of the research staff and collaborates with investigators and research teams to conduct clinical research activities. The Manager supports the Director of Research Site Operations in determining appropriate staffing levels for each site and the development of new approaches, methodologies and metrics to improve efficiency and effectiveness of WellNOW strategic outcomes for clinical research. Responsibilities include managing research operations; communicating with key research areas (e.g., Sponsors, CROs, IRB, HR, AP, Compliance); managing sites’ revenue and expenses; and assisting investigators, research teams, and research staff in the conduct of clinical trials. The Clinical Trials Manager supervises research coordinators, regulatory coordinator(s) and research assistants and trains new and existing investigators and research staff in collaboration with the QA, Training and Education Lead. The Manager helps ensure the regulatory compliance of the research sites with Good Clinical Practice and International Conference on Harmonization Guidelines, FDA Guidance, research SOPs and any requirements stipulated by the study sponsor. Ensures confidentiality and compliance are maintained at all times.

ESSENTIAL JOB FUNCTIONS:

• Manages day-to-day operations and activities to support the start-up, conduct, and evaluation of research activities of assigned sites
• Works with investigators to provide administrative and clinical oversight of studies to ensure efficient study start-up and progress according to study timelines
• Evaluates and review research opportunities and new protocols from investigators, industry sponsors, CROs, SMOs and other partners for potential participation
• Participates in protocol review and prepare materials to conduct feasibility review (e.g., enrollment projections; profitability analysis) in collaboration with Director, investigators and research staff
• Collaborates with investigators, research coordinators, urgent care and external organizations to identify all resources necessary to facilitate appropriate study activities/procedures, communication, support, and reporting of ongoing research
• Interfaces with the Institutional Review Board to facilitate the conduct and compliance of clinical research
• Tracks and prepares summaries of clinical research metrics of research activities of assigned sites
• Assesses competency and training of Principal Investigators and research staff for research activities
• Negotiates research services pricing contracts with affiliated entities
• Functions as key resource for operational questions from VP Research, Director, investigators, and WellNOW leadership
• Maintains ongoing communication with all investigators and teams on the status, safety/efficacy issues, and modifications of their specific studies
• Partners with VP Research and Director to evaluate performance of research team members; resolves performance issues, provides positive feedback; and takes appropriate corrective action when needed
• Initiates and directs employee practices to empower and reward staff for meeting company goals and demonstrating behaviors consistent with the company’s mission, vision, and values
• Monitors revenue and expenditure for each site to assure budgeted profit targets are on target or significantly above target
• Responds to escalated patient grievances and other operational issues
• Maximizes research opportunities both internally and externally
• Collaborates with VP, Director and QA, Training & Education Lead to set educational priorities and identify training needs; co-lead education and training of new and existing clinical research staff across the region
• Works with Director to track day-to-day workload and workforce needed for research activities at the assigned sites
• Champions operational excellence to provide continuous improvement of processes and sharing of best practices and participates in efforts to improve research across WellNOW
• Coordinates marketing and PR efforts to establish sound working relationships with internal and external clients, community and media
• Collaborates with VP Research,  Director and QA Lead on development and assessment of new and existing SOPs and research policies
• Ensures research compliance of the research sites and research team by participating in quality assurance activities and implementing recommendations
• Supports regular internal audits or external audits in areas such as patient enrollment, billing, contracting and financials
• Provides education, training and support to investigators to ensure compliance with SOPs
• Collaborates with the VP and Director to develop the operations budget for the assigned sites
• Maintains fiscal accountability, working with the team to ensure that activities are within allocated budget guidelines; ensure that adequate funds are available to permit the sites to carry out its work
• Other responsibilities as identified by research leadership

MINIMUM JOB QUALIFICATIONS:

• 7 years clinical trial experience & at least 3 years of research management experience
• Ability to self-direct and work independently and in a complex team environment
• Strong interpersonal skills and communication skills and the ability to deal with staff at all levels with sensitivity and tact
• Ability to succeed in changing environment and handle multiple competing priorities
• Ability to problem solve and facilitate consensus in a group environment
• Ability to establish and maintain successful relationships with potential sponsors, CROs and investigators
• Ability to work as a member of a diverse team, as well as an independent agent of change
• Knowledge of clinical research including the critical elements for the development and execution of clinical trials or research studies
• Knowledgeable in pertinent regulatory guidelines including Good Clinical Practice (GCP), International Conference on Harmonization (ICH) Guidelines and FDA Guidance
• Demonstrated ability to foster concepts of teamwork, research integrity and ethical conduct
• Experience in quality assurance, research auditing and/or SOP development preferred
• Strong skills in prioritization, organization, problem-solving, decision-making, time management, mentoring, planning, facilitating consensus and high level of attention to detail
• Ability to travel within designated markets (approx. 20%)
• Must have valid driver’s license
• Expertise with Microsoft Office
• Ability to work flexible schedule including evenings and weekends, as needed

EDUCATION:

• Bachelor’s Degree
• Masters Degree preferred

REQUIRED LICENSE OR CERTIFICATION

• CCRC preferred
• RN preferred

MENTAL AND VISUAL REQUIREMENTS:

• Works in clean, smoke-free and well-lighted spaces.
• Exposure to frequent deadlines/ must have ability to handle stress effectively, subject to frequent interruptions
• Must have good visual and hearing acuity.
• Must be able to utilize keyboard and view computer screens up to 90% of time
• Must be able to follow directions and plan fairly complex processes & workflow

PHYSICAL ACTIVITIES AND REQUIREMENTS:

• Ability to sit, stand, walk, use hands to finger, grasp, handle or feel, reach, stoop, kneel, crouch, or bend, climb, talk, hear, and perform repetitive motions of hands and/or wrists.
• Requires some physical work; lifting, pushing, or pulling required of objects up to 50 pounds.

EMPLOYER'S DISCLAIMER:

• All requirements are subject to possible modification to reasonably accommodate individuals with disabilities.
• This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position.  Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor. 
• The company reserves the right to add to or revise an employee's job duties at any time at its sole discretion.
• This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.