Organogenesis Surgical & Sports Medicine based in Birmingham, AL is seeking a motivated and responsible candidate for a Clinical Research Associate II position. The candidate must show initiative, strong communication skills, relevant scientific knowledge/experience, and be a team player. Excellent attention to detail, the ability to work independently, and good organizational skills are also essential to being successful in this position.
Organogenesis is a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the advanced wound care, surgical and sports medicine markets. The Birmingham, AL office invests significantly in research efforts at the bench, in preclinical models and in the clinical setting. Our research and development efforts are focused on placental-derived tissues as a platform for regenerative medicine. We currently have 4 products based on this platform that are clinically leveraged to aid in tissue healing and regeneration across a variety of clinical specialties including orthopedic surgery, neurosurgery, and plastic surgery. We are committed to evaluating safety and efficacy of these products in various applications using both preclinical and clinical research.
GENERAL SUMMARY OF POSITION:
Under the supervision of the Director of Research and Development the Clinical Research Associate II will assist in supporting the development and implementation of the Company’s sponsored clinical trials. Applicant will be expected to travel in this position, with travel comprising approximately 10% of time.
Assist the team in completion of all required tasks to meet departmental and project goals.
Assist in the development and implementation of sponsored clinical trials. Ensure compliance with the protocol, CFR, GCP, ICH and all internal procedures and guidelines
Assist in developing protocols to evaluate products in clinical applications.
Assist with all aspects of clinical document data collection (including preparing, editing, tracking, filing of clinical documents, and data entry.)
Set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
Assist in preparation for clinical site initiation visits, Investigator meetings, monitoring visits, regulatory audits, etc.
Prepare, track, obtain and/or file routine clinical study documents internally (including meeting agendas, minutes, schedules, calendars, subject screening logs, etc.) and insure distribution to clinical sites as appropriate.
Manage studies and sites on clinicaltrials.gov to ensure all records are up correct and up to date.
Submit protocols to appropriate institutional review boards, as required. Manage necessary progress reporting to IRBs.
Monitor clinical data on site or remotely as needed to ensure accuracy, thoroughness and regulatory compliance of clinical documentation and ensure resolution of data queries. Develop and execute monitoring plans for clinical trials.
Review and Validate Visit Billing for Clinical Studies.
May perform other duties assigned administrative tasks to support team members with clinical trial execution.
A 4-year university degree is required
5-10 years of experience as a Clinical Coordinator, CRA or CRO with trial management experience.
Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Proficient computer skills with Microsoft Office (Word, Excel, Powerpoint).
Excellent communication and organizational skills.
Knowledge of medical terminology, physiology and/or applicable disease states.
High attention to detail and accuracy.
Self- motivated and takes ownership of projects.
Results and solution oriented.
Experience with statistical methods relevant to clinical research.
Internal Number: 508
Organogenesis is a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the advanced wound care, surgical and sports medicine markets. The company’s mission is to provide integrated healing solutions that substantially improve medical outcomes and the lives of patients while lowering the overall cost of care.
Organogenesis' versatile product portfolio is designed to treat a variety of patients with repair and regenerative needs across the continuum of care.
Organogenesis Inc. was originally founded in 1985 as a spin-off of technology developed at the Massachusetts Institute of Technology (MIT). In 2017, Organogenesis acquired NuTech Medical, which further expanded our wound care portfolio and introduced product solutions for the surgical and sports medicine markets.
Today, Organogenesis has approximately 600 employees worldwide and is led by a management team of talented individuals with more than 100 years of collective regenerative medicine experience.
The Organogenesis corporate headquarters is located on our four-building campus in Canton, Massachusetts with ...additional offices in La Jolla, California and Birmingham, Alabama.
1998: FDA approves Apligraf® for the treatment of venous leg ulcers.
2000: FDA approves Apligraf® for the treatment of diabetic foot ulcers.
2004: Launch of full USA sales and marketing organization.
2006: European office established in Switzerland.
2014: Acquires Dermagraft® for treatment of chronic diabetic foot ulcers.
2015: Launches new PuraPly® product line.
2017: Acquires NuTech Medical and expands product portfolio to include Surgical and Sports Medicine.