Harbor Clinical

Coordinate regulatory submissions, manage essential documents, support clinical trial site start-up activities, and ensure compliance with regulatory standards. | Bachelor’s degree or equivalent, 2+ years clinical/scientific research experience, clinical study site start-up experience, strong communication skills, and ability to work in a team and fast-paced environment. | Harbor Clinical is seeking candidates for an in-house contract CRA opportunity. This position is Hybrid with in-office attendance required 3 times per week in the Marlboro, Massachusetts area. The contract is for 6 months with 40 hours per week. The CRA conducts clinical trial site start-up activities related to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures. Specifically, these activities will include: • IRB submissions and approvals. • Site informed consent form (ICF) customizations & negotiations. • Essential regulatory document collection. The CRA also provides support in enrollment, follow-up, and closure of clinical trial activities. Your responsibilities will include: • Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites. • Manage multiple sets of essential regulatory documents across several studies and division portfolios. • Partner with clinical sites to support the negotiation and customization of Informed Consent Form (ICF) • Develop and foster clinical research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies. • Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives. • Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking. • Manage and problem solve site start up challenges that arise to mitigate impact to service level agreement and study goals. • Develop, prepare, complete and track required regulatory, ICF and legal documentation. • Document clinical research site and investigator readiness for participation across multiple studies • Support internal quality audits, regulatory inspections, as applicable. • Update and maintain study-specific startup and close out trackers. • Update and maintain site specific metrics in Clinical Trial Management Systems, file and maintain site documents in eTMFs. • Provide updates to leadership on site start up activities, investigator readiness, regulatory submission, approval status, etc. • Escalate challenges and/or initiate outreach to Principal investigators, clinical research site coordinator, divisional clinical study leads and/or other stakeholders when appropriate. • Ensure compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WI, policies & procedures. Minimum Qualifications • Bachelor’s Degree, or an equivalent combination of experience and education. • 2+ years’ experience in clinical/scientific research and medical device experience, specifically clinical study site start-up experience within the US • Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment. • Ability to work in a team environment and possess clear, concise communication & presentation skills – written and verbal. • Must be comfortable interacting with clinical research site personnel via phone and email.