Job Title: Research Compliance Specialist

Job Description

A Research Compliance Specialist plays a crucial role in ensuring that all research activities adhere to established ethical, legal, and regulatory standards. Specifically, in the context of ClinicalTrials.gov, their responsibilities include managing submissions, maintaining data integrity, conducting audits, and providing training and support.

Responsibilities

• Manage ClinicalTrials.gov submissions, including preparing and submitting study protocols and results to the registry, ensuring all information is accurate and compliant with regulatory requirements.

• Maintain data integrity by ensuring that all study-related records are attributable, legible, contemporaneous, original, accurate, and complete (ALCOA-C).

• Conduct quality assurance audits of research studies and establish corrective action plans to ensure compliance with federal and state regulations.

• Provide training to staff on regulatory and study start-up activities, and support investigators in managing their studies.

• Collaborate with cross-functional teams to ensure that clinical trials are conducted, recorded, and reported in accordance with the protocol, company SOPs, and sponsor requirements.

Essential Skills

• Data entry

• Clinical trial management

• Compliance

• Clinical research

• ClinicalTrials.gov

• Data coordination

Additional Skills & Qualifications

• A Bachelor's degree in a relevant field such as healthcare, clinical research, or bioinformatics is required.

• Advanced degrees like a Master's in Public Administration (MPA) or Health Administration (MHA) can be beneficial.

• Certifications such as Certified Clinical Research Professional (CCRP) and Certified in Healthcare Research Compliance (CHRC) are highly valued.

• Several years of experience in clinical research, regulatory affairs, or compliance.

• Experience in managing ClinicalTrials.gov submissions and maintaining data integrity.

Pay and Benefits

The pay range for this position is $30.00 - $34.00/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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Apr 11, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.