The Institutions Partnership Manager is the primary point of contact and account manager for our institutions clients, with a focus on exceptional customer service to retain and grow these accounts. This role is the liaison between the client, the company and the Operations team. The Institutions Partnership Manager role is critical in understanding the needs and expectations of our institutional clients, meeting everything from their education on process flow to project management needs. This role also fulfills the duties required by our institutions agreements, requirements, and internal processes by communicating with the institution's contact to facilitate submission before and after review. Success in this role will be accomplished by effective, timely and accurate client communications (oral and written), establishing and reviewing key performance indicators, and active positive engagement. EDUCATION REQUIREMENTS:
Bachelor's Degree or equivalent experience
Current CIP (Certified IRB Professional) certification preferred
Knowledge of FDA Code of Federal Regulations and ICH Guidelines
Minimum of 2 years of experience in an IRB setting or 5 years' experience in clinical research directly managing the clinical trial process
Must be conversant with applicable regulations and industry standards governing clinical research and human subject protection.
Knowledge of FDA regulations as they relate to research and experience working with medical terminology preferred
Must have advanced knowledge in Microsoft Office and experience utilizing complex databases system in performance of your work. Strong skills regarding the development and delivery of presentations required.
Advanced knowledge of IRIS and operational workflow and submission process
Must have demonstrated sound judgment skills with ability to plan and organize work effectively and can rely on experience and judgment to plan and accomplish goals
Individual must possess the ability to work independently and responsibly. Must have demonstrated initiative and be a self-starter with ability to multi-task, work in stressful situations, and meet strict deadlines.
Must have strong analytical skills with a high degree of accuracy in a highly regulated industry
Must be able to maintain confidentiality
Strong interpersonal skills required such as a focus on resolving conflict, listening objectively and openly to others' ideas, and contributing to building a positive team spirit. Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team. Willingness to share and receive information and ideas from all levels of the organization to achieve the desired results.
Exhibit excellent verbal and written communication skills. Possess attention to detail with ability to proof-read and detect errors in typing, spelling, grammar, syntax and punctuation required
Stellar customer service skills
Previous Institutions experience demonstrating the knowledge and skills required for the position would be preferred
Primary client project manager and point of contact to implement process rules for the institution, inform and educate institutional contacts on our requirements, and respond to regulatory/medical inquiries for institutional clients. Inform Institutions contacts of any major changes to processes and procedures. Keep abreast of unanticipated problems or non-compliance to ensure the institution is informed of the issues prior to Board and following Board action.
Provide Institutions clients with resources and contact with Business Development for a fuller understanding and utilization of our company services, with a focus on growing the relationship between WCG and the client.
Interact with institutional contacts, including regular outreach to institutional IRB office contacts and others, offering solutions to clients' concerns, to ensure a high level of client satisfaction.
Employ trainings for site coordinators and PIs for a clear understanding of submission processes and electronic portal usage
Assist Client Care with any escalating issues reported by institution coordinators and PIs.
Collaborate with clients and assist in the coordination and processes flow through operations of documentation received by institutions, by informing and creating instruction regarding the institution
Prepare and maintain internal and external reports. Compose reports for institutional affiliates, to include excerpting minutes when required, and compiling data for institutional AAHRPP audits, accreditation, and re-accreditation. Create specialized reports as requested by the institution or the company regarding institutional issues, such as turn-around-time and error rate. Follow-up on incomplete, inaccurate, or delinquent site reports, obtaining supplemental information as requested by Operations Staff.
Work with all departments to ensure an understanding of clients' needs and expectations.
Maintain proactive ongoing communication with Institutions clients to identify issues that would affect the client's relationship with the company. Ensure all client contact information is current by regularly auditing study files to ensure notification required by the contract are triggered.
Participate in IRB Integration demonstration and trainings with IRBNet support
Relay messages and information as needed across functional areas
Occasional travel to meet clients or attend conferences may be necessary.
Evaluate and suggest procedural changes to encourage continuous improvement.
ABOUT US:For over 50 years, WCG IRB has been at the forefront of protecting the rights and welfare of human research participants during all phases of clinical trials. Recognized as the gold standard of human subject protection, WCG is the trusted partner to over 1,000 institutions in the United States alone, ranging from small community hospitals and research sites to large academic medical centers and universities. Our unparalleled review ensures that human research studies withstand scrutiny around the world.