Clinical research specialist job description

Post Market Clinical Development

Do you have a passion for working with clinical documentation and research for medical devices? And are you able to take responsibility and execute the right scientific level for the clinical documentation for our medical devices?

At Ambu, we develop, produce and sell medical devices, enabling healthcare professionals to save lives and improve patient care around the world where you will be instrumental in securing our ongoing dedication to quality products.

You will join the international Post Market Clinical Development team with highly dedicated and skilled colleagues.

A global clinical position with impact

As a Clinical Research Specialist, you will be involved in all clinical aspects of the post market product phase. Activities span from providing cross functional clinical support for a range of products and activities, develop and maintaining the clinical documentation to handling and executing clinical post market development and study activities.

Your primary areas of responsibility will be to:

* Take ownership and responsibility as post market clinical responsible for a range of products from market launch and throughout the product lifecycle.
* Develop and maintain the right clinical documentation level and be a proactive sparring partner in development projects and improvement activities.
* Support and continuously improve the strengthening of the clinical commercial foundation for our marketed products within the clinical indication areas.
* Balance your clinical scientific interest with a hands-on approach in activities as you drive, develop and maintain the clinical documentation and post market clinical follow-up activities.
* Be a strong and trusted clinical post market partner in our global organization.

You will work closely with colleagues in Global Clinical Affairs, Global Innovation, Marketing and Sales supporting their efforts and ensure ongoing support and development of high-quality products. You will work in an interdisciplinary position with various external and internal stakeholder.

As Ambu is a company with worldwide presence, international travelling should be expected as a part of the position, when possible again.

Cancer care is all we do

Hope in healing
Cancer Treatment Centers of America (CTCA), part of City of Hope, takes a unique and integrative approach to cancer care. Our patient-centered care model is founded on a commitment to personalized medicine, tailoring a combination of treatments to the needs of each individual patient. At the same time, we support patients' quality of life by offering therapies designed to help them manage the side effects of treatment, addressing their physical, spiritual and emotional needs, so they are better able to stay on their treatment regimens and get back to life. At the core of our whole-person approach is what we call the Mother Standard of care, so named because it requires that we treat our patients, and one another, like we would want our loved ones to be treated. This innovative approach has earned our hospitals a Best Place to Work distinction and numerous accreditations. Each of us has a stake in the successful outcomes of every patient we treat.

Job Description:
Hours: Mon - Fri 8:00am - 4:30pm CST

Job Summary:
Under the direct supervision of the Director of Research Operations, the incumbent is responsible for all regulatory documentation for assigned clinical research protocols including IRB submissions, IRB correspondence, actions to respond to IRB requests, and organized tracking of all regulatory, operations, and training documents for all clinical trials (investigator-initiated and sponsored trials) within the enterprise. This position will work closely with the clinical research nurses (CRNs) and clinical research coordinators (CRCs) to ensure compliance while meeting strict deadlines and adhering to Federal regulations, state/local laws relating to research and nursing, Institutional and IRB policies and procedures, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) guidelines. This position may also support processes related to administrative review, data management and tracking of applications for HRPP approval.

Job Accountabilities
Gathers essential protocol documents, drafts ICF according to IRB of record template requirements, completes IRB application, and manages required supplemental materials and signatures for IRB submission of new protocols.Tracks IRB submissions and correspondence including Initial Submission, Annual and Final Reports, Protocol Deviations, SAE, UADE, Enrollment and Study Closure notifications, Consent Forms, HIPAA, Assent, IFU, Recruitment Material, Investigator Brochure, Numbered Memos.Manages outstanding IRB requests for further action, additional documents, and/or revisions to ensure timely processing, accurate version control, and complete documentation.Creates and maintains regulatory files for all required documents including IRB Registration, IRB Roster, IRB Letter of Assurance/FWA Number.Assists the CRC or CRN with test article accountability, gathering and maintaining laboratory normals and certifications, staff training logs, and monitoring visits.Assist with operational forms, policies and standard operating procedures, as well as data entry and query resolution as needed. Works closely with Sponsors, Investigators, study personnel, and the IRB on pertinent regulatory issues.Acts as a liaison and process educator for facility staff who need assistance with IRB transactions.Determines site regulatory readiness for site initiation and close-out visits. Assists project teams with preparation for and participation in internal and external audits. Archives study specific regulatory documentation and correspondence.Apprise Director and other leadership, as appropriate, of all study and site-specific regulatory issues for guidance and follow through. Contributes to team decision-making concerning departmental policies, regulatory requirements, strategies and SOPs. Other administrative actions as required.

Education/Experience Level
Clinical/human research regulatory experience, knowledgeable of FDA/OHRP/GCP regulations and guidance, experience working in an accredited human research institution highly desired Computer SkillsThree to five years' experience in human research regulatory compliance/human research protection Three to five years' experience in human research regulatory oversight support required Experience with Institutional Review Board (IRB) application and review processes strongly desired, current/former IRB membership a plus,Experience preparing/reviewing IRB applications for non-Human research/Exempt category research highly desired Degree in healthcare/health sciences preferred

We win together Each CTCA employee is a Stakeholder, driven to make a true difference and help win the fight against cancer. Each day is a challenge, but this unique experience comes with rewards that you may never have thought possible. To ensure each team member brings his or her best self, we offer exceptional support and immersive training to encourage your personal and professional growth. If you're ready to be part of something bigger and work with a passionate, dynamic group of care professionals, we invite you to join us. Visit: Jobs.cancercenter.com to begin your journey.

Associate Clinical Research Specialist, Req#:
Location: Irvine, CA (this person is to be expected in the office all time, possible Hybrid schedule, maybe 4 days onsite and 1 day remote )
Duration: 6+ Months Contract
This is a supporting role, Supporting and assisting clinical research specialists

Job Description:
Education and Experience:

* Bachelor's Degree in a related field of study and 1 year of previous experience with regulatory documentation for clinical studies
* IRB submissions Nice to have
* EDC, Medidata RAVE, Veeva and CTMS exp is nice to have
* Medical Device industry is a must-have
Additional Skills:

* Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), and eTMF (electronic Trial Master file) preferred.
* Good written and verbal communication skills and interpersonal relationship skills
* Good problem-solving and critical-thinking skills
* Good knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
* Good understanding of regulatory submissions, reporting and audits Ability to manage confidential information with discretion
* Strict attention to detail
* Ability to interact professionally with all organizational levels
* Ability to manage competing priorities in a fast-paced environment
* Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
* Ability to build productive internal/external working relationships Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Key Responsibilities:

* Ensure clinical trials are conducted and reported by all applicable regulatory requirements
* Participate and support in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visit and site initiation visit)
* Conduct reviews of documentation needed for internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations Investigate discrepancies and participate in the development of processes to minimize the possibility of recurrence during study conduct and closeout Assist in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas