Staff Research Associate IV (Clinical Research Coordinator)

Position Definition:

The Clinical Research Coordinator (CRC) will be responsible for providing clinical and administrative support to the Principal Investigator (PI) for a variety of research studies conducted in the SFVAHCS Cardiac Catheterization Laboratory (CCL). Responsible for performing clinical research activities as delegated by the Principal Investigator within appropriate scope of practice. Ensure conduct of study activities according to study specific protocols, governmental regulations, GCP guidelines and local site SOPs.

The CRC will be responsible for the coordination of one or more clinical studies or clinical trials; help prepare protocols for study initiation; help design flow sheets, data forms and source documents; gather and interpret medical, surgical and laboratory data regarding participants; apply understanding of inclusion/exclusion eligibility criteria for protocols; help screen, recruit, enroll, consent, register, schedule and retain participants; record protocol specific treatments and assure collection, processing, and shipment of samples; assist research personnel to keep participants on study schedules; complete study forms to submit to sponsors and/or appropriate agencies; collect, enter and clean data into study databases, maintaining data quality; assist with data analysis; assist with preparation of reports and tables; attend team meetings including occasional travel to study-related meetings; and perform other duties as assigned.

In this position, the CRC will collaborate with faculty members, post-docs, graduate students, and undergraduates in both administrative and research capacities. This opportunity involves administrative, leadership, and research skills, and thus will be most suited to applicants who have had prior experience conducting human research.

Essential Functions:

• Contributes to planning and organizing the clinical aspects of the research studies. Identify and coordinate with interdisciplinary departments involved with the implementation of the clinical study. Provides in-services and support as needed for personnel involved with the care of subjects and research activities.

• Prepares and manages IRB submissions and reports. Maintain regulatory documents in compliance according to Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) procedures.

• Responsible for screening subjects to evaluate subjects' records to determine eligibility according to the protocol's criteria. Pl is responsible for final eligibility approval.

• As delegated by the Investigator, conducts the informed consent process and ensure all aspects of the process are met. Document the consent process according to. SFVAMC research policies.

• Collects clinical data required by the study protocol. Maintain complete and accurate case report forms and source documentation for each subject enrolled. Correct data discrepancies/inconsistencies identified in a timely manner.

• Documents all significant study patient encounters in CPRS, including appropriate clinical assessment and plan under supervision of PI, ensuring the PI is kept informed of all encounters and including the PI as a co-signer on progress notes.

• Communication of all protocol-related issues/problems to the PI and the sponsor. Report serious adverse events promptly according to the protocol requirements and local IRB and SFVAMC R&D policies.

• Ensures that Study Drug or Device administration is completed per protocol. Maintain complete and accurate records of the receipt, dispensing, retrieval and return of Study Drug or Device.

• Coordinates and participates in meetings, conferences, training sessions and other forums regarding the conduct of the clinical study, including national PI/ Study Coordinator meetings requiring travel. Identify any barriers regarding recruitment, enrollment, and any other issues involving study activities.

• Prepares and participates in quality assurance activities (monitoring visits, internal not for cause audits and sponsor audits).

• Ensure that all VA sensitive information is being used, stored and secured in accordance with the VHA policies and guidance.

• Assists PI with reimbursement submissions

• Maintains files documenting research trainings, credentials, research-related TMS certificates, CVs, licensing, certifications, memberships, and other related materials for each study team member and gives timely reminders and assistance as needed to maintain these and prevent expiration, and provides evidence to sponsors and others requiring it.

• Maintaining accurate and detailed records of research activities, including data collection and analysis

• Scheduling of study sessions, meetings, phone calls, etc.

• Screen potential study participants, obtain informed consent from study participants, explain study procedures to participants, and run study participants in IRB-approved studies

• Creating study materials

• Assisting with literature reviews

• Assisting with manuscript preparation

• Assisting with budget planning, negotiation, and contracting with sponsors

• Maintaining reliable and regular contact with faculty, and keep PI apprised of study updates

• Mentoring and training junior staff members, students, and interns in clinical research protocols

• Keeping abreast of new developments and advances in their field and incorporating this knowledge into their work

• Collaborating with other clinical research coordinators and Principal Investigators, both within and outside the organization, to advance the field of study

• Interacting with funding agencies, regulatory agencies, and other stakeholders to ensure that research activities are carried out in compliance with all relevant regulations and standards

• Strong technical skills, the ability to think critically and independently, and excellent communication and interpersonal skills are also important qualities for success in this role

• Performs other related duties as assigned.

Job Requirements:

• Ph.D or 7-8 years of experience

• Previous experience in coordinating and conducting clinical research studies. Preference for conducting Cardiac Catheterization Laboratory clinical trials or similar experience.

• Knowledge of the code of federal regulations for conducting clinical research, GCP guidelines and SOPs.

• Knowledge of IRS / SFVAMC R&D regulations and reporting requirements.

• Experience with conducting the research consent process and documentation and HIPAA regulations.

• Experience working with diverse teams of interdisciplinary administrators and clinicians with ease and professionalism to effectively coordinate study activities. Maintain professional conduct in the presence of subjects, clinical staff and sponsors.

• Ability to conduct and manage multiple projects, tasks and priorities to achieve desired goals.

• Required to have and maintain documentation of annual training in ethics of human subject research and GCPs.

• Ability to work under minimal supervision

• Ability to meet deadlines

• Strong accuracy and attention to detail

• General project management

• Excellent verbal and written communications and presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team.

• Proficiency with Microsoft Word, PowerPoint, and Windows.

• Excellent analytical and problem-solving skills.

• Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects.

• Ability to establish cooperative working relationships with patients, co-workers, and physicians.

Working Conditions/Environment:

The work environment for this position will include an indoor office and a medical research environment. It may include some minor annoyances such as noise, temperature variations, etc. The incumbent may sustain posture in standing or seated position and may utilize a computer terminal for prolonged periods of time.

The base salary range for this position is $32.00 - $50.70 per hour. The base salary actually offered to a successful candidate will take into account various relevant and non-discriminatory business factors including, without limitation, the candidate's geographic location, job-related experience, knowledge, and skills, and education, as well as internal equity considerations. A successful candidate may also be eligible to earn additional compensation including bonuses.