Career Opportunities

Human Clinical Research Manager (hCRM)

Location

Poway, CA

Description

VetStem Biopharma (VSB) is a contract research (CRO) and manufacturing (CMO) organization with roots in veterinary medicine but with expansion into human medicine. Personalized Stem Cells, Inc. (PSC) is a human stem cell therapy spinout company from VetStem and the Sponsor for multiple human stem cell clinical studies. VetStem is the CRO for all of these PSC human clinical trials. PSC will be sponsoring a significant number of Phase I/II clinical studies in US-based medical clinics under approved FDA INDs. These studies will assess the safety and efficacy of adipose-derived stem cell products for orthopedic and other medical conditions. VetStem will also assist physicians with Expanded Access Program submissions and management of these programs. We are seeking an experienced clinical trial and research professional to organize and conduct these studies in compliance with FDA rules and guidelines.

Responsibilities: The primary focus of this position is on the management and monitoring of human clinical study related activities. The monitoring will be both remote and on-site at each investigational site. The hCRM will be expected to perform site initiation/training, study monitoring, data collection and quality control, and study close-out, including on-site visits. hCRM will be expected to work with other VSB departments such as QA, Manufacturing, Regulatory and the PSC Medical Director. The hCRM will be the primary motivator and monitor of each study site and their staff to assure timely and accurate execution of the clinical trial protocol. The department will also have one clinical research associate with a primary focus of site and data management. Additional resources can be available from other departments as the needs arise.

Requirements

Knowledge, Skills, and Abilities:
-BA/BS in a science or health related field or Nursing Degree.
-At least 5 years previous clinical study management experience
-Excellent organizational and communication skills
-Computer proficiency, including the use of standard software (Word, Excel, databases, e-mail) and the use of Internet
-EDC implementation and operation experience important
-Time management skills and problem-solving abilities
-Excellent writing skills (Protocols, forms, instructions, SOPs, WIs)
-Ability to work with doctors and medical site personnel
-Excellent critical thinking skills including ability to rapidly adapt and learn
-Strong experience working in an FDA regulated clinical trial environment

Job Type: Full-time

Education: Bachelor's or Nursing Degree (Required)

License: Driver's (Required) Required travel: 10%-25% (Preferred) Specific Job Duties:

Study Management
-Create and maintain study activity calendar
-Maintain study budget
-Manage data receipt for site payment approvals
-Develop and update training materials
-Maintain Trial Master File (TMF)
-Coordinate weekly team meetings with clinical, regulatory, medical director and others as needed. Meeting to review safety, enrollment and operations.

Study Documents
-Draft or review Protocol, ICF, IB
-Create CRFs and instructions for paper or EDC use
-Create internal instructions and forms

Study Site Management
-Site Assessment: assist Medical Director in screening for site enrollment
-Site Initiation: training and document setup (GCP, study conduct, AE, recruitment)
-Provide all study materials (binders, recruitment materials, collection kits)
-Coordinate all shipments in/out (study materials, collection kits, drug)
-Approve patient recruitment materials
-Manage study timeline and calendar per site/patient to assure all data collected timely
-Triage all incoming site questions regarding possible patients for study participation
-Assure compliance with FDA, GCP, IRB, protocol and SOPs
-Routine Investigator communications – updates
-Manage all adverse event occurrence instigations to assure timely resolution
-Assure all regulatory reporting for each trial is completed (FDA, IRB, safety officer)

Study Data Management
-Manage all incoming data – organize, QC, store
-Manage data entry in EDC or other methods
-Review data at onsite monitoring visits and in EDC as appropriate
-Study closeout visit and collection of all raw data and study materials
-Assure data integrity through routine monitoring and QC checks
-Assist in creating study reports for IRB, SO, DSMB and FDA as appropriate