Clinical Regulatory Specialist - Cambridge, MA or Dallas, TX
Department: Clinical Operations
Employment Type: Full Time
Location: Cambridge, MA
Reporting To: Tammy Chan
Description
Iterative Scopes is seeking an experienced Clinical Regulatory Specialist to join our team. The Clinical Regulatory Specialist will work under the direction of the Director of Clinical Operations and Senior Clinical Regulatory Specialist, with the primary responsibility of assisting clinical research sites with the conduct and compliance of clinical trials.
This position will be a supportive and collaborative role in an office setting, working with team members, clinical sites, and study sponsors, requiring Administrative and Regulatory work.
Key Responsibilities

• Essential document preparation and organization
• Ensuring that site staff are trained on all current study documents and study delegation is documented appropriately
• All study documents reviewed, signed and filed by the appropriate study staff
• Preparing for and participating in audits and monitoring visits
• Assisting sites with keeping site staff credentials documents current
• Central IRB submissions on behalf of sites
• Project and Status Reporting of study start up and compliance
• Clinical site and sponsor communication
• Collaborating with Management team to optimize Regulatory processes
• Facilitating successful study start-up
• Helping sites to implement CTMS and assist with trouble-shooting as needed

Requirements & Qualifications
Ideal Candidate Profile:

• 4-year degree, preferably in a field related to healthcare
• 4+ years of professional experience
• 2+ years of experience with clinical trials regulatory compliance
• CRO or Sponsor experience preferred
• Experience in healthcare
• Excellent communication skills, both written and oral. Must be able to expertly and optimally deal with team members, external stakeholders, sites, etc.
• Excellent organizational and collaboration skills
• Strong decision making and prioritization skills
• Self-starter with a bias toward results and business outcomes
• Exceptional ability to be a team player
• Excellent follow up with team members and external stakeholders
• Takes initiative to anticipate and solve problems
• Ability to connect the appropriate team members and external stakeholders when necessary

Minimum Qualifications:

• Team player
• Ability to think on their feet and outside of the box
• Ability to work in a fluid environment
• Able to deliver in a fast-paced environment
• Professional communication, knowledge of grammar, spelling, and punctuation
• Exceptional organizational skills and keen attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Proven skills in time management, prioritization, and multi-tasking to meet project timelines
• Ability to identify problems, recommend solutions, analyze and present information
• Strong ability to establish and maintain effective working relationships
• Skilled at adhering to Good Clinical Practices (GCP), FDA essential documents guidelines, and Standard Operating Procedures (SOPs)
• Ability to competently use computers, the internet, Adobe, Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams), and clinical trial management system (CTMS)
• Must be able to lift up to 25 lbs.

Preferred Qualifications:

• Previous experience as a clinical regulatory compliance specialist
• Proven track record of success in previous roles
• Experience in a start-up environment where goals are often ambitious, and the environment and trajectory evolves rapidly
• Confidence and experience presenting to all environments

Benefits

• Vision/Dental/Medical Insurance
• Life/Disability Insurance
• Maternity/Paternity leave
• Stock Options
• Flexible Work Hours
• Unlimited Paid Time Off
• Fun Workspace (Standing Desks/ Pick your own workstation set-ups)
• Free Snacks and Drinks (Snacks upon request!)
• Remote work on Fridays

#LI-RZ1