Organogenesis Surgical & Sports Medicine based in Birmingham, AL is seeking a motivated and responsible candidate for a Clinical Research Associate I position. The candidate must show initiative, strong communication skills, relevant 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, Inc. 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 3 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 I 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 10-15% of time.
Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings
May draft materials including informed consent documents, protocols, draft source documents, patient instruction guides and case report forms
Coordinate activities of site staff and investigators to ensure compliance with protocol and overall clinical objectives.
To assist the Clinical team in completion of all required tasks to meet departmental and project goals.
Assists with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
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, and regulatory audits, etc.
Prepare, track, obtain and/or file clinical study documents internally (including meeting agendas, minutes, schedules, calendars, subject screening logs, etc.) and insure distribution to clinical sites as appropriate.
May participate in clinical monitoring duties.
Assist with regulatory submissions.
May perform other duties or assigned administrative tasks to support team members with clinical trial execution.
A 4 year university degree is required
2-3 years of experience as a Clinical Coordinator or Clinical Research Associate
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
Results and solution oriented
Internal Number: 408
About Organogenesis, Inc.
Organogenesis Inc. 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.... For additional information on our headquarters and locations, click here.
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.