Job Title: Clinical Research AssociateJob DescriptionWe are seeking a dedicated Clinical Research Associate to design, implement, and monitor clinical trials. The ideal candidate will have the ability to manage multiple aspects of clinical trials, ensuring compliance with protocols and regulatory requirements.Responsibilities
Design and update data collection forms (CRFs) and informed consent forms.
Assist sites in obtaining IRB approvals for trials.
Establish and maintain rapport with trial sites.
Liaise with investigators and site personnel to conduct trials.
Serve as the first point of contact for site inquiries regarding trial conduct.
Monitor and proactively address trial-related problems.
Set up trial sites, ensuring all materials are available for enrollment and procedures.
Address and assist with enrollment issues.
Coordinate the movement of laboratory samples and resulting data when central laboratory facilities are used.
Oversee the maintenance of Trial Master Files.
Train site staff on trial protocols.
Plan and order clinical trial materials throughout the study lifecycle.
Perform site visits and ensure trial compliance with current protocols and GCP.
Monitor site performance and adherence to protocols.
Review case report forms to verify data consistency with source documents.
Collect case report forms.
Write visit reports and follow up on unresolved issues with sites.
Maintain site tracking records.
Assist sites in liaising with internal review boards.
Review all SAEs to ensure proper notification of necessary parties.
Ensure all unused supplies are accounted for.
Close down trial sites upon trial completion.
Participate in departmental planning sessions and review progress of ongoing trials.
Respond to company, client, and federal regulatory requirements and audits.
Furnish clients with requested data promptly.
Ensure the rights and well-being of human subjects are protected.
Essential Skills
Experience in clinical research, medical devices, biologics, burn care, and clinical trials.
Proficiency in trial monitoring.
Pharma, biotech, or medical device experience required.
TMF experience.
Experience with Medidata and other relevant systems.
2-3 years of CRA experience.
4-5 years of overall experience.
Additional Skills & Qualifications
Experience in drug or biologic studies is a plus.
Work EnvironmentThe role requires full-time on-site presence, though remote candidates may be considered based on experience level. The studies are based in the US, with travel required 1-2 times per month within the country.Pay and BenefitsThe pay range for this position is $50.00 - $75.00/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 TypeThis is a hybrid position in Boston,MA.Application DeadlineThis position is anticipated to close on Feb 22, 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.