Clinical Research Specialist - Orthopedics
This Clinical Research Specialist (CRS) will have a combination of on-site clinical trial monitoring experience as well as the ability to manage the administration and compliance of the studies.
The CRS is responsible for facilitating assigned research studies in accordance with established procedures and regulations. The CRS executes strategies for pre- and post-market clinical studies and facilitates operational and logistical tasks to ensure efficient clinical trials. Collaborates with VP, Quality, Regulatory, Compliance, to ensure study activities occur in compliance with the appropriate regulations, including Food and Drug Administration (FDA) regulations, Investigational Device Exemption (IDE), 510 (k) guidelines, etc. The CRS coordinates resources for patient recruitment, trial site selection, and execution of trials with a focus on quality.
• Facilitates and tracks compliance of review process to ensure Acumed and Investigator-initiated research projects are ethical, medically relevant, and scientifically valid.
• Serves as internal and external point of contact for daily activities of assigned Acumed or investigator-initiated research.
• Administers site compensation on assigned projects, ensuring compliance and deliverables are met.
• Monitors and reports metrics on assigned studies to assess research performance, including speed and effectiveness of contracting, start-up, training, recruitment, protocol adherence, data collection and reporting.
• Interfaces with investigators, clinical site personnel, Clinical Research Organizations (CROs), Institutional Review Boards (IRBs), and appropriate company personnel as required regarding research projects.
• Collaborates with Regulatory and Compliance team members to ensure research needs are met.
• Performs clinical trial site visits as needed to ensure regulatory and study compliance.
• Collaborates with other team members to coordinate the development and finalization of key study documents.
• Contributes to the development of relevant standard operating procedures.
• BS or BA in Quality Assurance, Regulatory Affairs, Clinical Research or related field required; focus in biological science or research or equivalent preferred. Advanced degree preferred.
• Minimum 1-3 years of experience in Clinical Research.
• Demonstrated awareness and understanding of positive ethical and moral principles consistent with clinical research and the mission and values of the organization.
• Knowledge of FDA and International Conference on Harmonization (ICH) regulatory requirements and general clinical research operations.
• Demonstrated independent judgment and decision-making skills with respect to functional responsibilities.
• Motivated to optimize clinical operations processes to meet deliverables.
• Ability to effectively work with teams and promote collaboration.
• Excellent verbal and written communication skills
• Adaptable to changing environments.
• Able to work in a fast-paced environment.
• Manage multiple projects simultaneously.
• High level of proficiency in MS Office.
Acumed is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with a disability.
As an equal opportunity employer, Acumed is committed to providing reasonable accommodations to applicants with disabilities. If you are interested in applying to Acumed and need special assistance or accommodation, please contact us at [email protected].
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Regulatory Specialist 2
Janki prepares, reviews, and submits technical documentation to various health authorities—ensuring that Acumed receives the necessary registration for its products in all of the countries where it operates.
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