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.
Knowledge of medical terminology, physiology and/or applicable disease states
High attention to detail and accuracy
Results and solution oriented
Under the supervision of the Director of Research and Development.
ENVIRONMENTAL WORKING CONDITIONS:
Organogenesis, Inc. is committed to being an equal opportunity and affirmative action employer and recognizes the power of a diverse community. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or protected veteran status.
Review of applications will begin immediately and the position will remain open until filled.
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.