Senior Clinical Research Associate
MRC Clinical Research Associates (CRAs) report to MRC Project Managers and MRC Executive Management. CRAs collaborate closely with MRC Project Managers and MRC Data Managers to ensure effective development and execution of monitoring plans and related activities that adhere to regulatory guidelines, relevant MRC SOPs, study timelines and inspection readiness. CRA responsibilities include, but are not limited to:
• Assisting Project Managers with any trial related responsibilities and duties.
• Coordinating and scheduling trial team meetings to include preparation of agendas and meeting minutes.
• Communicating and obtaining information from potential investigative sites during site selection and qualification.
• Building productive relationships with investigators and coordinators to achieve study objects and subject recruitment goals.
• Preparing and shipping Investigative Site File (ISF) binders to sites prior to the start of the clinical trial.
• Filing and maintaining study records in the Trial Master File (TMF) to ensure compliance with required regulatory guidelines, GCP standards and MRC SOPs and reconciling contents of ISFs with the contents of the TMF to ensure all documentation is collected and current.
• Provide input and review on study related documents such as clinical monitoring plans, clinical data management plans, protocols, informed consents, case report forms (electronic or paper), CRF completion guidelines, EDC training guides, site instructions for specimen collection, laboratory manuals, investigative site GCP and protocol training materials, investigator newsletters etc.
• Assist in the development of tools to provide weekly progress reports to the Sponsor and MRC management.
• Assist in developing systems/tools to track all aspects of the trial, including all study, investigator and institutional/ethical review board information, patient enrollment activity, and financial management.
• Collecting and maintaining appropriate documentation for adverse event safety reporting and collaborating in the submission of safety reports to the FDA, IRBs/IECs and other applicable regulatory authorities.
• Assisting in the development of recruitment strategies to increase patient enrollment.
• Assisting in the development of tools for the provision, accountability and tracking of clinical trial materials such as Investigational Product (IP) and non-IP materials to investigative sites for the duration of the trial and ensuring site accountability records are maintained.
• Performing site initiation, interim monitoring and close-out visits according to the Clinical Monitoring Plan, applicable regulatory guidelines and MRC SOPs. To include the preparation of training materials used during visits.
• Preparing accurate and timely monitoring reports. To include visit agendas, confirmation letters and follow-up letters.
• Reviewing protocol deviations and clinical data to ensure reliable quality data are delivered.
• Issuing data queries for incomplete or inaccurate data and follow-up of queries until resolution.
• Collaborating with MRC Data Management during electronic data capture configuration, validation and data cleaning.
• Executing quality control procedures.
• Assisting in the financial management of the clinical trial including budget planning and tracking, resource allocation and preparation of quarterly reports.
• Providing support and assistance to sites preparing for clinical audits and responding to audit findings conducted by internal quality management or external regulatory agencies.
• Assisting MRC management in any activity or duty deemed necessary for successful trial implementation
• Bachelor Degree (BA/BS) in health, life sciences or related field is required; RN/BSN is preferred.
• Minimum of 3 to 5 years' experience as a CRA with a Contract Research Organization or in medical device or pharmaceutical company.
• Advanced knowledge of ICH guidelines on Good Clinical Practice and FDA regulations. International clinical trial experience and knowledge of other country regulatory requirements is preferred.
• Advanced computer skills in Word, Excel and PowerPoint are required. Experience with document management applications, SAS and Electronic Data Capture is preferred.
• Excellent communication skills (oral and written) and interpersonal skills are required.
• Willingness to travel (to include domestic and international travel) as required.
• CCRC/CCRP certification or equivalent is strongly preferred.
Morley Research Consortium has been committed to high performance standards for the past sixteen years. Coming from all areas of the biotech and medical device industry, MRC professionals are not only passionate about their work but have years of experience successfully managing all phases (I - IV post-market) of clinical trials in a wide variety of therapeutic areas. MRC's difference is in our people, knowledge, and results.
Sat, 12 Aug 2017 10:31:13 PDT