Current Open Positions
Research Assistant
General Summary of Responsibilities:
This is a highly responsible and professional position. The Research Assistant will work with a sponsoring company or CRO in the internal monitoring of a pharmaceutical, device, or biologics trial with an emphasis placed on ensuring the highest ethical and clinical standards.
The primary focus of this position is on coordinating in-house research associate and regulatory activities. Responsibilities will primarily involve learning study protocols, developing and providing services for the IMARC Chief of Clinical Operations; Director of Clinical Monitoring Services; and field CRAs; developing and providing services to site study personnel; maintaining and reviewing follow-up items, study databases and summary tables, internal training documentation, and internal document storage; assisting in report analysis, GCP audits and trainings. Additionally, the Research Assistant will serve as a resource person between IMARC CRAs, contracted sites and the sponsoring company or CRO. This position requires travel approximately 25% of the time to study-related meetings and visits to sites and the sponsoring companies or CROs.
Reports to: Chief of Clinical Operations
Qualifications:
- AS/AA in a health-related field or licensing/certification in a health-related field. BS/BA in a health-related field preferred.
- The following knowledge and skills are preferred:
- Knowledge of medical terminology
- Excellent organizational and communication skills
- Computer proficiency, including the use of standard software (word processing, databases, e-mail) and the use of the internet
- Time management skills and problem solving abilities
- Ability to work independently and with team
Specific Responsibilities:
In addition to the responsibilities listed below, the Research Assistant may be assigned other tasks as deemed necessary by management. The Research Assistant is expected to be able to perform the following activities:
Study Support:
Support sites as deemed necessary by the sponsor or CRO to ensure protocol compliance. Support may include, but is not limited to, the following:
- Developing a rapport with the study coordinators, principal investigators, and other study staff
- Fostering an atmosphere of support and teamwork
- Providing guidance to sites for completing study-related tasks
- Review and assistance with data queries
Management of Regulatory Documents:
Assist the sponsoring company or CRO in the maintenance of regulatory documents needed throughout a trial. This will include, but is not limited to, the following:
- Collecting curriculum vitaes and licensures
- Assisting with the filing of a 1572, if applicable
- Gathering of specific sponsor-required documents
- Monitoring communication with Institutional Review Boards
- Continuous monitoring of regulatory documents
In-House Activities:
- Obtain a familiarity with and understanding of clinical trial documentation format, content requirements, and operational procedures
- Assist IMARC team with the development, preparation and maintenance of study files
- As needed, collect, file, and retrieve regulatory documentation in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies
- Assist sites to resolve regulatory document issues
- Assist with data clarification resolution
- Update current study summary reports/records
- Review informed consent documents
- Assist field CRAs with site visit preparation
- Write confirmation letters
- Assist field CRAs with the review and resolution of tasks
- Complete document processing tools after field CRAs return from visits
- Assist with document processing and filing
- Assist with report corrections
- Track study issues and report them to Chief/Director
- Assist with the Internal QA department in file audits
- Assist with other departments as requested by the Chief/Director
Field Activities:
- As needed, cover for field monitors during site initiation/pre-site visits
- Act as co-CRA during routine, periodic site visits
- Perform general site contact activities, including but not limited to:
- Enrollment support visits
- Data extraction visits
- Significant telephone conversations/follow-up on visit items
Site Training:
Provide one-on-one training of site personnel including study coordinators and any ancillary staff that will be assisting with the trial. A report detailing the training session(s) will be generated and provided to the sponsor or CRO. Training will include, but is not limited to, the following:
- Thorough review of the requirements of the protocol
- Review of applicable FDA/GCP guidelines
- Review of Sponsor SOPs
If you're interested in a career with IMARC, please send your resume to [email protected].
