Actalent
Senior Clinical Research Associate
Actalent, Waltham, Massachusetts, United States, 02254
Actalent Senior Clinical Research Associate - Waltham, Massachusetts
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.
Minimum Requirements Global experience:
5+ years of clinical operations experience, including at least 2 years of monitoring experience.
Additional Skills & Qualifications:
BS degree in life sciences or healthcare discipline.
Knowledge of good clinical practice (GCP) and FDA and ICH regulations and guidelines.
Demonstrated efficiency in partnering with CROs and vendors.
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 This is a fully remote position with a preference for candidates in the EST timezone.
Pay and Benefits The pay range for this position is $70.00 - $75.00 per hour.
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)
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.
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:
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
#J-18808-Ljbffr
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.
Minimum Requirements Global experience:
5+ years of clinical operations experience, including at least 2 years of monitoring experience.
Additional Skills & Qualifications:
BS degree in life sciences or healthcare discipline.
Knowledge of good clinical practice (GCP) and FDA and ICH regulations and guidelines.
Demonstrated efficiency in partnering with CROs and vendors.
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 This is a fully remote position with a preference for candidates in the EST timezone.
Pay and Benefits The pay range for this position is $70.00 - $75.00 per hour.
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)
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.
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:
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
#J-18808-Ljbffr