Clinical Research Associate
MED Institute, Inc. is currently accepting applications for a Clinical Research Associate to become a part of our growing Clinical Study Operations team. This is an in-house position where the individual is responsible for supporting the daily activities of clinical studies to ensure they are being conducted, recorded, and reported in accordance with the study plan/protocol, Cook procedures, applicable regulations and signed investigator agreements in order to meet global clinical study objectives.
- Remotely monitor studies by sending queries, processing responses and ensuring that the dataset remains complete and accurate;
- Identify and report to project management any issues which may need attention at a particular investigative site; support resolution as needed;
- Ensure that data are entered into the appropriate database and any issues identified are promptly resolved;
- Travel to investigative sites to perform site visits if necessary, which may include, training, assessment of adherence with the study plan/protocol and applicable regulations, and general support and training of the physician and his/her research staff;
- Generate detailed and timely site visit reports as needed following each visit;
- Assist in the development and/or peer review of study plans/protocols, data collection forms, patient summaries, submissions to regulatory authorities, and other study-related documentation as needed;
- Compile and distribute the investigator file and brochure;
- Track IRB/Ethics Committee approval and renewals; prepare and respond to IRB/Ethics Committee submissions or correspondence;
- Track and archive essential documentation, such as insurance, agreements, CVs, etc.;
- Assist in checking device accountability, as appropriate;
- Work closely with both process and project management to determine priorities and ensure that project objectives are met;
- Establish trusted relationships with physicians, their research staff, the project team and study sponsors through communication and a commitment to exceeding expectations.
- Communicate information and study requirements to investigators or site personnel on an ongoing basis; and
- Complete relevant ad-hoc tasks, as assigned.
- BA/BS, preferably in a life science, nursing, pharmacy related field, or similar experience within science, healthcare or quality;
- Knowledge of applicable international standards and other regulatory requirements that may impact clinical studies is preferred;
- Conscientious, influential person with an outstanding work ethic and strong personal discipline;
- Willingness and capability to handle multiple projects and responsibilities;
- Excellent organizational and problem-solving skills;
- Excellent written, listening, and verbal communication skills; and
- Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues.
Cook Medical - 7 months ago
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...