Medical Research Associate
DOCS is currently seeking an experienced Clinical Research professional for a Medical Research Associate opportunity working remotely within the United States. This position will work as a member of the Clinical Trial Team in the Study Management and Conduct Group supporting the Clinical Trial Monitor. The Medical Research Associate is responsible for end-to-end site management activities.
• Maintain oversight of all site start-up and conduct-related activities (e.g. contracts, Essential Documents (e.g. RegDocs), training, Informed Consent Form updates, IMP re-supply).
• Responsible for site logistics including review, distribution and tracking of site related documents & materials (e.g. ICFs, protocols, supplies).
• Update and maintain trial-specific system/databases/tracker (e.g. IVRS, BI CTMS, GEM).
• Responsible for project compliance according to project plans and related tools.
• In close partnership with other stakeholders (e.g. Manager, Site Monitoring), maintain quality and operational oversight for assigned sites and escalate issues to the CTM and/or Lead MRA, as appropriate.
• In close partnership with other stakeholders (e.g. CRAs), take appropriate actions and make recommendations to the CTM and/or Lead MRA for improving site performance and/or quality.
• Identify risks, and propose and implement mitigation strategies.
• Perform monitoring trip report review & sign-off. Communicate significant issues to the CTM and/or Lead MRA.
• Serve as CAPA lead.
• Develop trial specific documents (e.g. newsletters). Submit for review and approval to CTM and/or Lead MRA.
• Closely track site recruitment and patient retention.
• Maintain oversight of data quality and integrity through review of systems and trackers (e.g. BRAVE, lab portals, Clinergize).
• In collaboration with Local TMF Records Specialist (LTRS) / Global TMF Record Specialist (GTRS), ensure quality of TMF for assigned sites.
• Review and reconcile invoices/payments with internal partner(s), as appropriate.
• Actively participate in trial team meetings including the creation and distribution of meeting minutes.
• Create trial specific slide decks, training material, etc. in accordance with BI requirements.
• May support Customer Relations Group in answering and appropriately routing site calls.
• Participate in (local/regional) Investigator Meetings, as requested.
• Support site & sponsor inspection readiness activities.
• Provide support to US-based Trial Clinical Leaders (TCL) who lead global trial teams during planning, conduct and reporting clinical trials.
- Strong Communicator
- Be a highly motivated individual with the ability to think critically, that is detail oriented, can multi-task and understand the clinical trail process, meet deadlines and keep a trial/site on track along with any other qualifications provided by sponsor
- Proficiency in computer skills with direct working expereince in multiple electronic platforms such as but not limited to: Shar Rooms, Clinical Trial portals, Central IRB portals, Time reporting portals, Learning portals, Access Databases, Microsoft Excel, Microsoft Skype, Adobe Acrobat Professional and scanning software etc.
- Maintain expertise of currently assigned Sponsor SOPs, Working Instructions and where applicable departmental practices
- Maintain current knowledge of ICH, GCPs, applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets, PhRMA code, and industry standards for the monitoring of clinical trails at no cost to Sponsor
- Represent Sponsor with the highest ethical and professional standards
- 4 year college degree
DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.
DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.