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Regulatory & Study Start Up Specialist II

Annapolis, MD 21401

Posted: 08/05/2025 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 621131 Is job remote?: No Country: United States

Job Description

Description:
Job Overview
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions
• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Qualifications
• Bachelor's Degree Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
• 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Good negotiating and communication skills with ability to challenge, if applicable.
• Effective communication, organizational, and interpersonal skills.
• Ability to work independently and to effectively prioritize tasks.
• Ability to manage multiple projects.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, including local regulations,, SOPs and company’s Corporate Standards.
• Understanding of regulated clinical trial environment and knowledge of drug development process.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients








Pay Rate Range: $30-38/hr depending on experience 
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About Annapolis, MD

Ready to take your career to the next level in Annapolis, Maryland? This vibrant city, located on the picturesque Chesapeake Bay, offers a unique blend of historical charm and modern opportunities. Imagine working in the shadow of the stunning United States Naval Academy or exploring the quaint streets lined with colorful historic homes. With renowned seafood restaurants like Cantler's Riverside Inn and lively entertainment venues such as Maryland Hall for the Creative Arts, Annapolis is a hub of culture and excitement. Don't miss out on job openings in this dynamic region - discover your next career move in Annapolis today!