Posted on October 28, 2012
Clinical Trials Network Coordinator
BioMedical Institute of the Americas
BioMedical Institute of the Americas - Clinical Trials Network Coordinator
The Medical Center of Americas (MCA) Foundation is seeking a qualified candidate for the role of Clinical Trials Network (CTN) Coordinator at the Biomedical Institute of the Americas (BMIA), a 501(c)3 non-profit organization located in El Paso, Texas.
The CTN is one of four elements of the BMIA, including (1) the Translational Research Collaborative (TRC) designed to generate biomedical innovation, (2) the Incubation Center, designed to mine innovation, manage proof-of-concept projects, and provide intensive support to biomedical start-ups, (3) the Competitiveness Group, designed to strengthen and grow the region’s biomedical cluster and value chain, and (4) the Clinical Trials Network.
In this role, the individual will be responsible for creating the region’s CTN by engaging the Paso del Norte region collaborative, comprised of academic and community research network that spans four university institutions and many hospitals and physician practices in the region, and cataloging the region’s assets that can be used for clinical trials. The CTN coordinator will educate providers and patients on the value of clinical trials to better engage them in the Network. The Coordinator will provide overall site support for multiple clinical research trials operating in the region. This individual serves as a vital link between investigative site and sponsor team by supporting and collaborating with practice management, physicians and clinical research staff, and Institutional Review Boards (IRB) that make up the overall CTN infrastructure.
He or she will perform a variety of subject care and administrative duties to support activities that meet objectives of assigned research protocol(s), including supporting and collaborating with practice management, physicians and clinical researchers. The Coordinator will provide leadership in identifying research operational opportunities to assure quality trial conduct while maintaining fiscally sound programs.
PRINCIPLE REQUIREMENTS AND RESPONSIBILITIES
Develop the Regional Clinical Trials Network: Overall responsibility for the development of the regional CTN. Meet with local healthcare providers and catalog the region’s research base (i.e., providers, patient case mix, etc.). Educate institutions, providers and patients on the value, benefits and risks of actively engaging in the CTN. Obtain agreements with providers to participate in clinical trials when available and appropriate for the patient population. Write and maintain CTN policies and procedures.
Coordinate Regional IRB Reciprocity: Work with all regional institutions that have Institutional Review Boards (IRB) to create reciprocity agreements so that if one intuition’s IRB approves a study protocol, all other regional institutions will give reciprocal approval of the protocol. Ensure that IRBs providing and accepting reciprocity are maintaining their IRB to the highest standards through periodic auditing, monitoring and reporting activities.
Create Regional IRB: To cover studies that will be performed in sites that do not have their own separate IRB, create a regional IRB to ensure that as many clinical sites in the regional can participate in clinical trials with the appropriate oversight. Manage the IRB structure, organization, governance, legal requirements and processes.
Create CRO Affiliations: Develop collaborations and affiliations with national Clinical Research Organizations (CRO) to bring a higher volume and quality of appropriate clinical trials to the region. Present CROs with regional assets and help target appropriate clinical trials for the region’s assets. Negotiate agreements with CROs for clinical trial requirements, responsibility and compensation.
Coordinate and Manage Clinical Trials: Ensure that Clinical Trials Coordinators at trial sites are performing the following functions and/or perform the following functions for clinical trials for which the CTN Manager is responsible:
Provide Training: Provide training and direction to assistants or new personnel on protocol procedures. Work with regional Institutions of Higher Education to develop training programs for clinical trials.
- Provide subject care and data collection procedures in adherence with the assigned study protocol and in accordance with good clinical research principals. Ensure that IRB approval of protocol and informed consent form is obtained prior to initiation of the study.
- Review subject charts, database records, and other sources to screen and identify potential subjects for inclusion in study based on criteria described in the protocol. Confer with subject and physician to explain purpose of study. Explain diagnostic procedures and method of treatment to answer subject and family concerns. Obtain written consent for subject to participate in a study prior to initiation of any protocol procedures.
- Maintain accurate records of the receipt, inventory, and dispensation of study drug and materials. Work with the nursing staff to administer study drug to research subjects.
- Obtain and coordinate subject blood samples, cultures, tissues, and other specimens for laboratory analysis as described in study protocol. Collect pertinent information and data from subject charts and records, subject interviews, and other sources. Complete case report forms (CRFs) in accordance with research protocol guidelines.
- Inspect CRFs, source documentation, and study files to ensure completeness. Review CRFs, source documentation, and study files with representative from sponsor, consortium, or Food and Drug Administration (FDA) at each visit. Make necessary corrections to CRFs and submit requested documentation in a timely manner.
- Comply with standard operating procedures of the sponsor, IRB, and consortium involved with the trial. Compile and submit reports, documents, and correspondence as necessary to the IRB, sponsor, and consortium.
Maintain Current with Industry Knowledge: Review journals, abstracts, and scientific literature to keep abreast of new developments.
QUALIFICATIONS AND COMPETENCIES
Educational and Work Experience: BA, MA, RN, LPN, LVN, medical assistant, Lab Technician or other medically related or research experience. Clinical research accreditation, such as Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA). At least 7 to 10 years of experience in a health or clinical research environment.
Clinical Research and Biomedical Regulatory Experience: Ability to understand and communicate research protocol requirements to others and strong facility and knowledge of medical terminology. Knowledge and insight into legal and regulatory matters concerning clinical research, such as FDA guidelines and GCP. In depth experience with IRBs.
Communication Skills: Excellent English and Spanish language skills, both oral and written.
Project Management and Organizational Skills: Excellent project management, organizational and prioritizing capabilities. Well-developed analytical abilities and problem solving skills. Strong experience in managing people at various levels, working with providers and patients in positive manners.
Technical Skills: Strong computer skills and experience using clinical trial databases, EDC, Access and Excel.Application Instructions
To apply for this position, please submit a cover letter, your resume/CV and contact information for three (3) references (professional and civic in nature) to emma@MCAmericas.org.