Job Title: Senior Clinical Research Associate

Job Description

The in-house Senior Clinical Research Associate (CRA) performs a key role in building relationships with site personnel such as clinical coordinators, study investigators, and pharmacists, while contributing significantly to the management and execution of the clinical trial. CRAs will collaborate with other cross-functional team members in this high-profile role. They will communicate regularly with Clinical Trial Managers (CTMs) regarding work progress and apply knowledge of clinical site and vendor oversight. The Senior CRA will also provide oversight of monitoring activities and may be expected to co-monitor with CRO or contract CRAs, and/or act as a primary site monitor for study sites.

Responsibilities

• Build and maintain relationships with clinical coordinators, study investigators, and pharmacists.
• Contribute significantly to the management and execution of clinical trials.
• Collaborate with cross-functional team members.
• Communicate regularly with Clinical Trial Managers regarding work progress.
• Apply knowledge of clinical site and vendor oversight.
• Provide oversight of monitoring activities.
• Co-monitor with CRO or contract CRAs as needed.
• Act as a primary site monitor for study sites.

Essential Skills

• Global experience
• Hematology experience
• CRO oversight experience
• 5 years of clinical operations experience
• 2 years of monitoring experience

Additional Skills & Qualifications

• BS degree in life sciences or healthcare discipline.
• At least 5 years of clinical operations experience including at least 2 years of experience monitoring oncology trials preferred.
• Knowledge of good clinical practice (GCP) and FDA and ICH regulations and guidelines.
• Demonstrated efficiency in partnering with CROs and vendors.
• Maintain professionalism in difficult situations.
• Remain flexible in terms of assignments in support of a trial.
• Ability to remain organized while effectively managing time and assigned tasks.
• Good verbal and written communication skills.
• Ability to prioritize tasks and work independently.
• Experience working with EMR, eTMF, and CTMS systems.

Work Environment

100% remote work environment with preference for candidates in the EST timezone.

Pay and Benefits

The pay range for this position is $70.00 - $75.00

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position will be accepting applications until Jan 20, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $70 - $75