Clinical Research Coordinator II
The Clinical Research Coordinator II will provide support, as funding permits, to various research efforts across our clinical divisions. The successful candidate will coordinate and participate in the support and administration of clinical research studies conducted by principal investigator(s) or research site leader including, but not limited to, grant funded research and/or industry sponsored clinical research conducted on site or affiliated sites; coordinate and participate in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Coordinate and participate in the initiation; monitoring, completion, and reporting to moderately complex clinical studies in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP).
Characteristic Duties and Responsibilities
Study planning and start-up procedures
- Review journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.
· Participate with principal investigator(s) or research site leader and/or other members of the research team in the development of plans and protocols for clinical research studies
· Coordinate the project budget development and costing process; support coordination of required research process with other offices (e.g., research billing, Contracts and Grants Administration, MSU Technologies, ORCBS)
- Oversee the development of forms, questionnaires and the application of research techniques; coordinate the writing of procedure manuals for data collection and coding.
- Assist in the determination of guidelines for the collection of clinical data and/or administration of clinical studies
· Confer with site coordinators and physicians to explain the protocol and to elicit compliance with regulations; assure adherence to FDA and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate.
- Implement training of new site personnel in study-related processes and procedures;
- Provide guidance to lower level personnel involved in planning, implementation and evaluation of clinical studies. Assist in training new personnel.
· Coordinate assigned multi-site or large-scale clinical trials research studies conducted by a supervising principal investigator(s) or research site leader in support of activities that meet objectives of assigned research protocol(s).
- Prepare study regulatory submissions; monitor study participants’ progress to include documentation and reporting of adverse events and required notification of regulatory agencies
- Develop recruitment plans and facilitate enrollment of study participants; confirm participant inclusion/exclusion criteria
- Inform study participants of research study purpose; explain diagnostic procedures and/or treatment plans to alleviate participant and/or family concerns; obtain informed consent when appropriate
- Provide assistance to the PI in clinical and research procedures as required by study protocol; assist with interviewing study participants, administration of questionnaires
- Oversee and coordinate scheduling of study participants for study procedures; coordinate drug orders, laboratory procedures and treatments for participants based on standing protocol orders.
- Coordinate and perform basic lab procedures, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-ups
- Oversee the distribution of appropriate forms, supplies, equipment, laboratory samples and drugs required for execution of research protocol(s); oversee support staff and/or contracting agents in the receipt and dissemination of study materials.
· Contribute to the ongoing analysis and modification of protocols and study design as appropriate; coordinate the recommendation and preparation of amendments to investigator-initiated clinical research protocol(s) in conjunction with appropriate study personnel.
Data collection, management, compliance
- Coordinate updating of study source documents, training materials, advertisements and other study-related documentation as required by protocol changes
- Coordinate and implement procedures to collect data from study participant charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation;
- Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and recommend corrective actions as appropriate.
· Create a variety of reports, documents and correspondence for regulatory agencies,participating clinical trial sites and for internal purposes to assist in the ongoing monitoring and evaluation of the clinical research project’s progress.
- Review work of CRC I positions and support staff within designated areas
· Inspect study files to ensure completeness and accuracy of data; perform QA checks on data
- Follow established guidelines in the collection of clinical data and/or administration of clinical research projects including trials
- Evaluate and interpret collected clinical data in conjunction with principal investigator(s) or research site leader as appropriate; prepare oral presentations or written reports and analyses setting forth progress, trends and appropriate recommendations or conclusions.
- Confer with principal investigator(s) or research site leader to discuss the interpretation of results; collaborate on the preparation of manuscripts for publication.
- Perform other related duties incidental to the work described herein.
- The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Knowledge equivalent to that which normally would be acquired by completing a four-year college degree program in a health related science field; more than three years of related and progressively more responsible or expansive work experience with clinical trials including phlebotomy and processing of labs; budgeting experience and safety requirements; experience with blood borne pathogens; or an equivalent combination of education and experience; completion of required Institutional Review Board training and certification within the first 30 days of employment and certification as a Clinical Research Associate within the first three years of employment; possession of a valid vehicle operator's license.Required Application Materials
CVCover Letter Work Hours
STANDARD 8-5Description of End Date
This is an off-dated position funded for one year from the date of hire with possible extension contingent upon funding renewal.Summary of Health Risks
- Exposure to human blood, serum, tissue and other body fluids; and materials covered under Universal Precautions.
- TB risk or work within 3 feet of human patients in a health care setting or have potential exposure to animals or to specimens with Mycobacterium.