Site Management Specialist
Do you have experience managing clinical research sites? Have you managed and supported clinical research sites contracted by your organization? Do you have experience supporting international clinical research sites? The Leidos Life Sciences Division is looking for a Site Management Specialist to join their growing team in support of our government and commercial clients in the infectious disease and vaccine development fields. This person will work with CROs, clinical sites, sponsors, and other stakeholders to ensure clinical sites successfully execute the clinical protocol. Position is contingent upon contract award. Based in Frederick, Maryland.
• Perform administrative tasks to support team members with efficient and timely clinical trial startup, execution, and closeout.
• Utilize knowledge of GCP and all applicable federal/local regulations to mitigate protocol-related issues experienced by the CRO or the sites.
•Serve as the CRO or site investigators’ main point of contact for protocol-related questions/concerns; ensure questions are answered by the appropriate team member.
• Assist in communicating all training requirements and contractual/regulatory processes required for conducting clinical studies. Communication may be to a CRO or directly to the clinical sites.
•Track all study and high-level site activities and provide timely reports to management.
•Participate in meetings regarding clinical research activities.
•Work closely with the clinical research management team to draft/execute timely communication of all research updates.
•Provide assistance with clinical research recruitment planning.
•Troubleshoot logistical challenges in protocol implementation and conduct and maintain FAQs (or similar tools) for participating investigators and research staff to access.
• Create and maintain metrics to assess the CRO and the sites’ performance.
• Create and maintain standard operating procedures related to site management.
Bachelor’s degree in science or related field required.
Minimum of 5 years related clinical research experience in a healthcare, pharmaceutical/CRO or clinical setting required
Ability to plan and communicate complex logistics involving multiple sites, tasks and priorities.
Excellent communications skills including the ability to articulate details from elaborate information/data, convey facts objectively, knowledgeable in regulatory guidelines and clinical terminology, and providing sound analytical support.
Ability to work independently. Proficient in identifying inefficiencies, establishing root causes, and proposing resolutions to difficult challenges.
Ability to make appropriate determinations, committed, confident, and exhibits resourcefulness.
Experience working as part of a team, collaborating and often contributing to discussions.
Ability to establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
ACRP/SoCRA certification preferred
Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.