Senior IN-HOUSE Clinical Research Associate

Job Title: Senior IN-HOUSE Clinical Research Associate

Job Description

The Senior IN-HOUSE Clinical Research Associate (Sr. CRA) will be responsible for establishing, managing, and meeting milestones of clinical studies in compliance with applicable clinical and regulatory standards and in alignment with business needs. The role involves strategic, project, and resource management responsibilities for assigned clinical programs to evaluate the safety and effectiveness of interventional products. This position requires a motivated, self-starter who can work independently once projects are assigned, and entails significant interaction with cross-functional counterparts and contract research organizations in global studies.

Responsibilities

• Participate in the design and execution of global studies for regulatory submissions, reimbursement, and product adoption, including clinical study documents, study implementation, and data management.
• Manage study preparation, activation, enrollment, submission, maintenance, and closure activities.
• Participate in administrative activities within the clinical department including procedures, training of key personnel, and preparation and maintenance of objectives and budgets.
• Interface with representatives from key functional groups to drive product development and clinical-wide or cross-departmental initiatives.
• Ensure appropriate oversight of clinical studies by internal and external resources, including monitoring staff, CROs, and core laboratories.
• Manage key study investigators and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
• Negotiate contracts with hospitals, consultants, investigators, CROs, database management firms, and outside suppliers.
• Evaluate clinical and adverse event data during the conduct of the study and for completion of clinical study reports and other technical documents.
• Ensure quality by maintaining compliance, reviewing device complaints, reviewing audit reports, and implementing corrective actions.
• Regularly communicate study status to Senior management and represent the organization to key customers.
• Other duties as assigned.

Essential Skills

• Bachelor’s Degree in a scientific field of study with a minimum of 5 years’ experience directly supporting clinical research.
• Working knowledge of Good Clinical Practice (GCP), FDA, ISO, and other applicable regulations.
• Knowledge of FDA and international regulations and guidelines, including clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance, and medical device reporting.
• Strong written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology.
• Ability to travel up to 25% domestically and internationally.
• High attention to detail and accuracy.
• Proficient computer skills (MS Office products, word processing, spreadsheets, etc.).
• Finance and budgeting knowledge.
• Good prioritization and organizational skills.
• Excellent critical thinking, influencing, and negotiation skills.
• High energy and results-oriented individual who is mature and successful in a business environment.
• Proactive and 'can do' attitude.
• Works effectively on cross-functional teams.
• Effective written, verbal, and presentation skills with all levels of management and organizations.
• Operates both as a team and independently, with adaptability to changing requirements.
• Ability to work in a fast-paced environment, managing multiple priorities.

Additional Skills & Qualifications

• Clinical research certification from ACRP or SOCRA preferred.

Work Environment

The role offers a flexible work environment with options to start at 7:30am in either PST or EST time zones. The candidate may occasionally need to work past 5pm to complete tasks. The position allows for remote work from any location and involves a dynamic, team-oriented atmosphere. The candidate may be required to travel domestically and internationally up to 25% of the time.

This is a Contract position based out of Santa Clara, CA.

The pay range for this position is $44.00 - $60.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• 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)

This is a fully remote position.

This position is anticipated to close on May 7, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.