Clinical Operations Associate jobs in the United States

We are looking for an experienced Associate Director, Clinical Operations to join our team!

Are you a self-driven leader who can provide oversight to the Clinical Operations group while promoting team effort and accountability? Can you quickly respond to unexpected changes and make sound decisions? If the answer is yes, keep reading.

In this position you will:

• Provide oversight, management, and leadership of Clinical Operations (Project Management) and Trial Master File Management.
• Supervise, coach, and mentor team members reporting to this position. Work with each team member to set clear job expectations, assess training needs, and ensure team members receive training as needed.
• Develop and maintain long-term professional relationships with sponsors and vendors.
• Oversee quality, accuracy, and timeliness of the deliverables of the Clinical Operations teams.
• Interact with sponsors and vendors and participate in meetings, as necessary, to support and maintain success.
• Develop and manage multidisciplinary project team activities. Assess project issues and propose resolutions to the project team, Director of Operations, CPC Leadership Committee, and the sponsor.
• Provide regular updates to supervisor on all staff, key performance indicators, timelines, and deliverables as necessary.
• Ensure appropriate resourcing and personnel allocation for evolving business and project needs within Clinical Operations on individual employee, functional area, and project metrics.
• Provide strategic input into innovations and contribute to the achievement of functional area goals.
• Develop and review/approve applicable Clinical Operations policies, Standard Operating Procedures and Work Instructions.
• Oversee compliance with applicable policies, standard operating procedures (SOPs), work instructions (WIs) as well as applicable regulations and guidelines.
• Function as an Executive Clinical Operations Manager for assigned projects. Provide mentoring, support, and back-up for all relevant project activities. Ensure overall quality and project services.
• Assist Business Development with benchmarking for budgets and development of proposals and service agreements.

  Here’s what you will need to bring to the table:

• Nursing or BA/BS in a scientific field preferred but not required.
• A minimum of 7 years of experience in clinical trials, or equivalent experience.
• A minimum of 1 year of supervisory experience.
• Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
• Excellent interpersonal communication skills, good problem solving and organizational skills and great attention to detail.
• Experience with MS Office including Project, Access, PowerPoint, SharePoint, Word, and Excel.
• Ability to work as a member of a team and to organize, instruct and supervise staff, while promoting group effort and achievement.
• Ability to manage conflicts and resolve problems effectively.
• Ability and willingness to travel up to 15%.

Targeted Compensation: $107,000 - $130,000 annually

Deadline to Apply: November 1, 2024

Note: Viable applicants will be required to pass a background and education verification check.

About CPC:

CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.

CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.

CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/

CPC offers:

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
• Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
• 11 paid holidays
• 15 - 25 vacation days based on years of service
• Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) 
• In-suite exercise and relaxation room
• Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
• Flexible and remote work schedules

An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at careers@cpcmed.org.