****Regional Clinical Research Site Lead***

Job Description

The Regional Clinical Lead (RCL) will focus on the oversight of rare disease studies at investigative sites. The RCL ensures that clinical studies are conducted, recorded, and reported in accordance with the protocol, SOPs, ICH-GCP, and all applicable regulatory requirements. The RCL will be responsible for managing 10 sites, effectively communicating with CRAs, investigators, site staff, clinical study teams, cross-functional teams, and other external partners.

Responsibilities

• Engage study site personnel (Principal Investigator, Sub-Investigators, study coordinators, other HCPs) to maintain focus on study design, rationale, and eligibility criteria.
• Identify operational hurdles/challenges and offer strategic solutions; apply mitigations broadly between sites and across studies.
• Ensure quality execution of clinical studies.
• Participate in study start-up activities, including feasibility, site selection, document development, and review.
• Perform monitoring oversight of CRO CRAs, including site assessments, initiation, interim, and closeout visits when necessary.
• Build partnerships with CRO CRAs and perform oversight visits.
• Review previous monitoring visit reports and follow-up letters; meet with CRAs prior to visits to discuss plans and observe visit conduct.
• Document visit findings, review findings with CRAs, and provide assistance/feedback when necessary.
• Complete sponsor oversight accompanied visit reports and escalate any findings.
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Essential Skills

• BS/BA degree or equivalent, preferably in life sciences.
• 5 years of relevant experience, including CRA and management roles.
• Experience in monitoring quality oversight.
• Recent experience working for a sponsor with CRO oversight.
• Experience in site relations, rare diseases, and site management.
• Excellent verbal and written communication skills.
• Ability to travel (50% travel required).

Work Environment

Travel (US Passport required) is approximately 50%, including visits for all SIVs, co-monitoring, site progress visits, relationship building with sites, and CRA quality oversight. Central Time Zone is ideal, but flexible to Eastern Time Zone as well.

Pay and Benefits

The pay range for this position is $80.00 - $85.00/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 Mar 28, 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 : $80 - $85