Baylor Scott & White Health Research Project Analyst III Job in Temple, Texas
JOB DUTIES AND RESPONSIBILITES SUMMARY
Facilities the research process through the timely preparation and submission of regulatory documents for Scott & White physicians, fellows, residents, and non-physician scientists who are actively involved in research (external and internal funding sources). Will assist investigators in identifying potential funding opportunities and providing technical support for grant writing. Will interpret and extract appropriate information from research protocols or proposals to develop essential regulatory documents. Responsible for the management of all regulatory files for the duration of the study or grant to ensure compliance with Federal and Institutional policies regarding human research.
* Serves as a liaison by clearly communicating and coordinating with outside sponsors or granting agencies and their representatives for internal or external studies on a regular basis.
* Communicates information to the institution regulatory and compliance offices.
* Responsible for regulatory communications and submissions to the IRB.
* Communicates with Manager on a regular basis and keeps them abreast of essential/important information relating to the regulatory status of all clinical research studies.
ORIENTATION TO THE RESEARCH PROCESS
* Completes and maintains institutional orientation and requirements including TB skin testing and Collaborative IRB Training Initiative (CITI).
* Attends and participates in the staff meetings, Research Department meetings/forum, and Quality Assurance presentations (if applicable) along with any reviews of standard of operating procedures for the regulatory office.
DEVELOP ESSENTIAL STUDY DOCUMENTS FOR THE STUDY INITIATION PHASE
* Recognizes and accurately completes the essential elements of an initial site start-up package and submits to the sponsor, funding agency, and/or grants.gov in a timely manner.
* Navigates the research protocol for information necessary for completion of all required regulatory documents.
* Familiar with informed consent required and optional elements and ensures that they are drafted and incorporated into the informed consent document.
* Works closely with the Research Grants Program (RGP) staff to facilitate a smooth regulatory submission to the institutional IRB after funding award.
* Provides timely regulatory submissions to the Institutional Review Board (IRB) for all just in time external grant award notices.
ASSISTS WITH THE MANAGEMENT OF ALL REGULATORY DOCUMENTATION TO ENSURE COMPLIANCE DURING THE INITIATION AND FOLLOW UP PHASE OF A STUDY
* Familiar with the required elements and organization of a regulatory binder.
* Tracks and updates in a timely manner study essential documents when new versions are available.
* Manages and updates all IRB communications.
* Communicates regularly with the sponsor and research staff for study updates requiring IRB notification and submission.
* Assists with internal and external audits of the regulatory binder and follows up on questions/concerns in a timely manner.
ASSISTS RESEARCH STAFF WITH THE CLOST OUT PROCESS AT STUDY COMPLETION/TERMINATION
* Meets with research staff to verify accurate and up to date completion of all essential regulatory documentation.
* Completes all recommended edits/corrections required by the sponsor, funding agency, and/or research staff in a timely manner.
* Completes and submits the progress reports and final progress reports to the IRB and/or funding agency, and ensures that a copy of acknowledgement is provided to the sponsor and/or funding agency.
FULFILLS CONTINUING EDUCATION AND/OR CERTIFICATION REQUIREMENTS TO MAINTAIN REQUIRED QUALIFICATIONS
* Remains current with changes in research policies and regulations by actively participating in team sharing and learning activities.
* Participates and/or leads classes provided by Scott & White including Scott & White University courses.
* Researches documentation to gain knowledge and remain current in assigned areas.
* Participates in departmental cross training opportunities when available to increase base knowledge of research processes.
* Remain a resource to researchers in staying abreast of current funding trends; i.e. web casts, meeting, etc.
* Continually analyzes all regulatory processes to ensure the best product and service for the customer.
* Evaluates research staff concerns and issues and provides one on one instruction to the staff as required or requested.
SUPPORT, MENTORSHIP, AND TRAINING
* Supports the Research Project Analysts I by providing mentorship, training, etc. (external and/or internal funded studies).
* Demonstrates independence in completion of all regulatory documents and provides clean submissions and correspondences to all required contacts.
* Demonstrates professional communication and program specific support skills as required to work with various levels of leadership.
* Maintains a good working relationship with internal and external customers in systematic problem solving with the ability to resolve issues independently.
* Acts as Scott & White marketing advocate at national/international meetings. Gives presentations as requested at national/international meetings.
* Provides mentorship to lower level Research Project Analyst by analyzing growth and providing leadership and training as needed to successfully complete assigned regulatory tasks.
* Provides personalized training to Sr. Staff and/or the research study personnel if necessary.
PERFORMS OTHER POSITION APPROPRIATE DUTIES AS REQUIRED IN A COMPETENT, PROFESSIONAL AND COURTEOUS MANNER.
KNOWLEDGE, SKILLS, AND ABILITIES
* A Bachelor's degree (e.g., BA, BS, BSN, BSW) required.
* A minimum of 3 years experience required.
Experience 3+ Years
Job Family: Research & Education