Senior Manager, Regulatory

ABOUT EMVENIO RESEARCH:

EmVenio Research delivers localized trial access to diverse and underserved communities. We empower patients and embrace communities on their terms. Our research solutions cultivate a sustainable local ecosystem that benefits all stakeholders. Removing barriers and unlocking doors to innovation reduces risk and time associated with clinical research, while improving ROI.

EmVenio Research offers competitive pay, a comprehensive benefits program and opportunities for learning and career development. We promote a diverse and inclusive workplace, and our team members have a voice in their work through surveys and town halls.

POSITION SUMMARY:

Responsible and accountable for managing, the regulatory affairs function within EmVenio Research, in the areas of regulatory submissions, documentation, education, training and compliance, including the use of Good Clinical Practice principles with understanding and application of Food and Drug Administration regulations and International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines.

The regulatory staff ensures smooth coordination of research activities with clinical research staff, sponsors, CROs, IRBs, and other internal stakeholders. This position provides regulatory oversight, organization, and coordination of research involving physicians and clinicians, as well as other involved departments. The ideal candidate will possess strong written and verbal communication skills, attention to detail, ability to meet multiple changing deadlines, and the ability to work independently. This position will be remote.

ESSENTIAL FUNCTIONS:

Reasonable Accommodations Statement: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

• Updates Clinical Trials Management System (CTMS) as needed with essential profile information (CVs, medical licensures, laboratory accreditations), IRB status, consent form versions (protocol/consent form evolution), and safety information.
• Prepares regulatory documentation packets and creates all FDA 1572 Forms for IND filings. Distributes financial disclosure forms, protocol signature pages, and FDA 1572 forms to obtain investigator and staff signatures.
• Assists with the completion of signature logs, training logs, and all regulatory documents. Ensures all necessary forms are submitted to the Sponsor company to activate protocols.
• Assembles regulatory ‘binders’ both in the CTMS and Physical where mandated by a sponsor
• Posts regulatory documents including protocols, amendments, consent forms, SAE forms, etc. in the CTMS.
• Submit initial applications for study approval to the IRB. Submit continuing review reports, closeout reports, and other materials to the IRB for approval and process accordingly.
• Prepares, maintains, updates, and audits study-specific regulatory files, IRB files per FDA guidelines and resolves queries, as necessary.
• Distributes IRB documentation and post IRB meeting information to study sponsors, research, and clinical staff accordingly.
• Communicate effectively with the company’s coordinators, Site managers, Project managers and management teams; pharmaceutical companies; CRO’s; IRBs; study sponsors, and other team members.
• Advise others on regulatory and compliance matters.
• Identify and interpret relevant regulatory guidelines.
• Performs regular reviews on investigator site files to ensure compliance
• May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.

Supervisory Responsibilities:

• Recruits, interviews, hires, and trains new staff as needed.
• Oversees the daily workflow and compliance of the department staff (currently one Regulatory Coordinator)
• Provides constructive and timely feedback and performance evaluations.

POSITION QUALIFICATIONS:

SKILLS AND ABILITIES

Education & Experience: Bachelor’s Degree in healthcare or science-related field

Experience: Minimum of 2 years experience in leading a regulatory department within a clinical research site, site network, SMO or IRO and liaising with IRB’s & Sponsors.

ComputerSkills: Strong proficiency in Microsoft Office programs (Outlook, Word, Excel, Adobe) and web applications

Certificates & Licenses: ICH-GCP Certification

Other Requirements:

• Knowledge and understanding of human research policies, regulations, procedures, and standards according to FDA, ICH, GCP guidelines are preferred.
• Supervisor experience preferred
• Ability to plan, organize, set priorities, and work in a fast-paced environment and handle multiple projects simultaneously and efficiently with precision.
• Ability to Create and maintain controls on documents.
• Ability to use software to develop organized information sources and to provide a variety of reports.
• Must possess excellent verbal and written communication skills.
• Ability to work well independently as well as with co-workers, peers, supervisors, and external sources.
• Ability to adapt to changes in responsibilities and workloads.
• Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic.
• Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, subject matters, and other confidential information.
• Demonstrated capacity to problem solve, think critically and creatively, and provide support through a consultative role.
• Ability to communicate effectively when reading and writing e-mail, letters, and other reports.

WORK ENVIRONMENT:

Work is performed primarily remote, typically in a home office. From time to time travel may be expected, but this will typically be in an office / conference environment. The noise level in the work environment is usually quiet in office settings and moderate in other situations.

The preceding functions may not be comprehensive in scope regarding work performed by an employee assigned to this position classification. Management reserves the right to add, modify, change or rescind the work assignments of this position. Management also reserves the right to make reasonable accommodations so that a qualified employee(s) can perform the essential functions of the position.

Location: Remote (Preferrable located in CST or EST)

Amount of Travel Required: 10%

Schedule: Monday – Friday, 8am-5pm

Compensation: $90,000-$110,000. The actual salary offered will carefully be considered by a wide range of factors, including your skills, qualifications, experience, and location.

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