Job Title: Associate Director, Clinical Operations (FHI Clinical)

Job Location : United States of America

Time type : Full time

About The Company

FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research, technology, communication and social marketing — creating a unique mix of capabilities to address today’s interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.

As we evolve to meet the challenges of the future, we stand committed to the principles that have guided our organization for the last 40+ years. Our work continues to be grounded in research and science, strengthened by partnerships and focused on building the capacity of individuals, communities and countries to succeed.

Summary of the Position:

This role will collaborate with Clinical Operations Management staff to ensure the successful management, performance, and career development of Clinical Team Managers, Lead Clinical Research Associates (CRAs) and Clinical Research Associates (CRAs). Provides training and consultation related to clinical operating activities in the conduct of clinical trial projects. Also responsible for contributing to and participating in activities supporting marketing and business development. Assures compliance with Good Clinical Practices (GCPs), ICH, Standard Operating Procedures (SOPs), FHI Clinical policies and procedures.

Essential Functions:

• Line management for assigned CTMs, Lead CRAs and CRAs in the following areas:
  • Quarterly Goals and Objectives for each direct report to document performance progress
  • Evaluates and identifies resource issues and plans to resolve challenges.
  • Communicates with the CTMs and/or Lead CRA, as needed, to ensure correct monitoring resources per project.
  • Liaise with Project Managers to ensure monitoring deliverables/targets are met, ensure project hours are met, ensure excessive total hours are noted and action taken, as necessary.
  • Ensures any project issues and results of discussions with Project Managers and are escalated appropriately.
  • Assesses training requirements for monitoring staff.
  • Conducts performance to assessments to verify the effects of training on efficiency.
  • Conducts field evaluation visits with staff at sites.
  • Conducts regular one-on-one meetings with staff to discuss performance.

• Reviews and approve time sheets and expense reports as required.
• Coach, train, and support direct reports.
• Provides staff with expert clinical research and therapeutic advice.
• Assists with Global CRA teleconference monthly.
• Maintains an awareness of company policies to effectively represent the company perspective to clinical staff.
• Identifies training needs and ensure staff participation during in-house training activities as required.
• Assist with the development and administers an effective orientation/on-boarding process for new Clinical Operations Staff.
• Maintains awareness of overall development in the field of clinical research and ensures that staff remains current on clinical monitoring developments.
• Clinical Operations Department Duties/Responsibilities:
  • Creates, reviews, and revises departmental SOPs, working practices, and policies, as necessary.
  • Assist with the hiring process and providing recommendations and/or decisions on new staff.
  • Evaluates hiring and equipment needs and reports as necessary to leadership.
  • Assists with the creation and deliver new department initiatives, improvement plans or training.
  • Assists with developing functional area goals which correlate with corporate goals and formalize departmental action plans to meet those goals.
  • Assists in developing department budget and is accountable for the profit/loss and the overall financial performance of the Clinical department.
  • Assists Director, Clinical Operations with Process Improvement Plans and other special projects as required by the department.
  • Provides oversight of clinical projects to ensure quality delivery on client deliverables.
  • Manages escalations as per process and follows through to resolution of issues.
  • Collaborates with other department and/or functional groups to ensure consistency of processes.
  • May represent functional area in internal or external audits

• Business Development Duties/Responsibilities:
  • Participate in the development of the clinical portion of client proposals including preparation of clinical project budget and text.
  • Preparation for and attendance at capabilities and bid defense meetings.
  • Participate in marketing activities, client presentations, and proposal development.
  • Participate in and/or attend professional and industry meetings as a representative of FHI Clinical.
• All other duties as assigned.

Knowledge, Skills and Abilities:

• Hands on leader that has the ability to wear multiple hats
• Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management.
• Strong communication skills (verbal and written) to express complex ideas.
• Excellent organizational and interpersonal skills.
• Positive attitude and ability to interact with all levels of staff.
• Must be able to multiple tasks and have a level of flexibility that can support group priorities across the company and staff needs.
• Ability to mentor and train clinical staff.
• Working Knowledge of Word, Excel, and Power Point.
• Working knowledge of current ICH/GCP guidelines and applicable country specific regulations.
• Valid driver’s license: ability to rent automobile.
• Willingness and ability to travel domestically and internationally as required.

Position Requirements:

• Education: Bachelor’s degree in a life sciences program or RN/BSN with a minimum of eight (8) years of direct experience in clinical studies or equivalent level of education, training and experience.
• Preferred Job-related Experience: Must have at least five (5) years of experience as a Clinical Research Associate/Clinical Monitor, with at least four (4) years as a successful Lead CRA/Clinical Trial Manager. Understanding of the entire clinical research process is mandatory. Prior global/multi-region trial management experience is required. Previous site management experience is required. Must have demonstrated ability to lead and motivate a group of clinical research personnel.
• Additional Eligibility Qualifications: Excellent organizational, communication (written and verbal), and interpersonal skills. Must be able to work independently, prioritize, and function effectively within a matrix team environment. Has a working knowledge of the MS Suite (Word, Excel, PowerPoint, etc.)
• Preferences: Previous experience in personnel management within a clinical research environment preferred. Prior proposal development and bid defense participation is preferred. Prior budget development and management experience is preferred. Prior experience in electronic data capture (EDC) is preferred. Prior vendor management experience is preferred.

Physical Expectations:

• Typical office environment.
• Ability to sit and stand for extended periods of time.
• Ability to lift 5-50 lbs.

Travel Requirements:

• Expected travel time is 50% for this position.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.

FHI Clinical, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

Please click here to continue searching FHI 360’s Career Portal.