Location: Wenatchee, WA
Facility: Wenatchee Valley Hospital
Schedule: Full Time
Shift: Day Shift
Hours: 8 - 5
Assist with the preparation, submission and maintenance of clinical trials regulatory data. Assist with the initiation and maintenance of all human subjects and regulatory documents necessary for submission to the institutional review boards, study sponsors, and various agencies in order to obtain initial and continued approval of all clinical trials. These activities require compliance to several sources of complex regulations, policies, and procedures concerning the conduct of clinical trials, including those of the FDA, NIH, GCP, and ICH. The position requires strong writing and verbal communication skills, attention to detail, ability to meet multiple and changing deadlines, the ability to interact with a variety of people and to consult numerous sources for information in order to prepare documents and assist with responses to IRB and sponsor questions that are compatible with numerous policies and procedures. Incumbent must be able to work in a very busy interactive environment with frequent interruptions and to perform tasks accurately and quickly.
1. Prepares regulatory documentation for study start-up from sponsor. Consults with department management staff to establish principal investigator (PI), sub-investigators, coordinators and other staff for inclusion on the FDA Form 1572.
2. Obtain copies of the study synopsis or protocol. Provide copies to involved staff to include: principal investigator; sub-investigators; study coordinators; department medical director; department manager. Provide staff with start-up documents needing signature and date.
3. For new clinical research studies; complete the FDA Form 1572 with investigator signature; obtain and submit signed, dated CVs and medical licenses for all involved staff; submit local laboratory licenses and normals; submit draft of patient information and consent form.
4. Review or create the Patient Information and Consent Form (ICF). Ensure that all required elements are within the document. Provide draft ICF for review by the principal investigator. Determine with management the patient stipend to be included in the ICF.
5. Receive recruitment materials from coordinators or business development coordinator. Provide sponsor with copy of proposed ad material and receive sponsor approval. Submit sponsor approval and proposed ad materials to IRB for approval. Notify when approved.
6. Prepare institutional review board (IRB) submission letter. Submit all required documents to study sponsor and IRB. Keep staff and department management informed of progress of new study submission.
7. Process the submission and approval of any protocol amendments. Obtain a track changes version of the amendment. Obtain PI signature for submission to sponsor. Provide copies of the protocol amendment to all involved staff. Provide revised ICF to coordinator.
8. Maintenance of ongoing studies: Process any revision of the FDA Form 1572 to sponsor and IRB. When indicated, provide new CV, medical license, financial disclosure and other supporting documentation.
9. Process IND safety reports and amendments to the clinical investigator brochure. Download or copy each safety report for review by the PI. Provide accompanying memo with safety report according to department SOP. Send copy to IRB. Notify sponsor of submission.
10. Process study continuing review reports for the IRBs. Collaborate with coordinator to complete the necessary information on the form accurately. Obtain copy of most recently signed ICF. Submit report to IRB with copy to sponsor. Fulfill report deadline dates.
11. Work with coordinators to prepare study close out reports for the IRB. Complete necessary information on the form accurately. Compile study close out letter. Submit complete report to the IRB, copying sponsor. Maintain appropriate documentation in study files.
12. Receive all protocol deviation reports and serious adverse event reports (SAE) from coordinators. Work with management to determine if the report meets criteria for informing the IRB of a deviation or SAE. Provide detailed report to the IRB as appropriate.
13. Serve as an expert on all research study regulatory matter, including FDA regulations and guidance, Good Clinical Practice criteria, International Conference on Harmonization rules and regulations, and IRB reporting criteria.
14. Maintain study site reference manuals for each study with all required training, paperwork, and submission documentation.
15. Other duties as assigned.
16. Demonstrate Standards of Behavior and adhere to the Code of Conduct in all aspects of job performance at all times.
High School graduate; college course work desirable.
Office experience required, minimum two years. Experience with computer programs, including Microsoft Office and internet.
Previous experience in a clinical research, regulatory document preparation and submission, or similar work experience.
Demonstrated organizational abilities and analytical reasoning.
Strong proof reading skills and attention to detail.
Ability to work well in a group, as well as independently.
General business office skills to include typing, telephone, filing, etc.
Strong interpersonal communication skills with excellent grammar and spelling ability.
Medical terminology desirable.
Ability to manage several concurrent tasks on a regular basis.
About Confluence Health: Confluence Health is an integrated, rural healthcare delivery system with two hospitals, multi-specialty care in 30+ service lines and primary care in 11 communities across north central Washington State. Our 270 physicians and 130 advanced practice clinicians serve an area of approximately 12,000 square miles and cover nearly every corner of this region through specialty outreach. Our Mission: We are dedicated to improving our patients' health by providing safe, high-quality care in a compassionate and cost effective manner. Our Setting and Lifestyle: We are located in the heart of Washington State and just 2.5 hours east of Seattle. Our region offers a diverse array of recreational opportunities in breathtaking landscapes, from alpine country to the high desert, orchards to vineyards, cross country skiing to fly fishing and everything in between. Cycling, mountain biking, rafting, hiking; it is all right here. The region also offers a family friendly environment with excellent schools and cultural and art activities for the entire family.Apply