Senior Clinical Research Coordinator

VCU Institute for Drug and Alcohol Studies

At VCU, we are UNCOMMON and UNLIKE any other university. A premier, urban, public research university nationally recognized as one of the best employers for diversity, VCU is a great place to work.

It’s a place of opportunity where your success is supported and your career can thrive. VCU offers employees a generous leave package, career paths for advancement, competitive pay, and an opportunity to do mission-driven work.

VCU's Office of the Vice President for Research and Innovation and the Institute for Drug and Alcohol Studies (IDAS) invites all interested candidates to apply for our exciting Sr.

Clinical Research Coordinator position! (IF IDAS, also include : IDAS advances multidisciplinary research and training on the neuroscience of addictions and related neurobehavioral disorders.

VCU is UNLIKE the rest. Our impact is measured one student and patient at a ’s unequaled combination of excellence, diversity, research and creativity makes success possible for every one of our 300,000+ RAMily members.

And that makes us one of the most innovative universities in the country.

A premier, urban, public research university nationally recognized as one of the best employers for diversity, VCU is a great place to work.

It's a place of opportunity, where your success is supported and your career can thrive.

All full-time staff are eligible for our generous benefits package that includes choices for health, vision, and dental coverage, life-insurance, short and long-term disability coverage, retirement planning, tax-deferred annuity and cash match programs, flexible spending accounts, tuition benefits, significant paid-time off,12 paid holidays, and more.

Explore our benefits further here :

Position Primary Purpose and General Responsibilities

The VCU Institute for Drug and Alcohol Studies is hiring for a senior level clinical research coordinator position to facilitate multiple clinical research trials with a focus on substance use disorders.

The coordinator will participate in all aspects of the studies and contribute to data collection, processing, analysis, and dissemination along with senior project investigators, project staff, and trainees.

The coordinator will be responsible for supervising research assistants and student worker staff.

The general responsibilities of this role are as follows :

• Maintain advanced understanding of clinical research management duties from study initiation to closeout.
• Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, plus additional sponsor GCP certifications as required.
• Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved protocols.
• Be directly responsible for study coordination and regulatory management of an assigned portfolio of clinical research studies covering a variety of diseases and conditions.
• Assist in the training of research assistants and student researchers on the team.
• Serve as an ongoing resource for providing information and expert advice on clinical research issues.
• Lead the development of best practice guidance and work aids for CRCs in areas such as : study activation, study coordination, data management, and records management.
• Follow VCU internal processes to ensure compliance with VCU policies related to research activities and ensure compliance with federal and state regulatory standards.
• Establish standard operating procedures for all research-related activities
• Overall implementation and daily management of research protocols.
• Clinical research activities including screening, enrolling, and testing participants, as authorized by the Principal Investigator.
• Ensure IRB submissions are complete and submitted on time. Adhere to study timelines and deliverables.
• Responsible for key aspects of the human resources process, annual reviews and on-boarding for postdoctoral fellows, research assistants, and interns, including close supervision and training of research assistants and interns.
• Organize and set agendas for meetings and take meeting minutes.

Minimum Hiring Standards

• VCU supports a diverse faculty, staff, and student environment. The candidate will demonstrate experience that shows their commitment to fostering such an environment.
• Bachelor’s degree or equivalent applicable combination of training, education and experience.
• 3 years minimum direct experience managing study coordination and regulatory affairs for clinical trials.
• Strong communications skills, attention to detail and time management skills
• Ability to set priorities, make timely decisions and meet deadlines while working on multiple projects.
• Ability to work collaboratively and cooperatively in a large and complex organization and in a diverse and fast paced work environment.
• Must be able to complete mandatory competencies and certifications required by VCU and VCUHS, individual clinical trials and the NIH Human Subjects Protection training.
• Computer skills including word processing, data entry, spreadsheet, database management, and mid-level data analysis / statistical / programming skills required

Preferred Hiring Standards

• Prior experience in administrative and financial management in an academic setting (including a working knowledge of state / university purchasing, travel, personnel administration policies and procedures).
• Prior experience with grant submissions, research administration, pre / post award functions, subawards, working knowledge of NIH and other federal and state regulations / policies.
• General understanding of IRB policies pertaining to regulatory requirements in human research.
• Research experience with human subjects, including data collection, coding, and analysis.
• Familiarity with open science platforms ( OSF) and electronic data capture platforms ( Qualtrics, REDCap, Inquisit / Millisecond).
• Master’s degree
• Certified CRC (CCRP, ACRP-CP, CCRC, or CCRA) certification
• Experience working with subjects with mental health disorders or substance use disorders
• Experience administering semi-structured interviews (ie ASI, SCID, or MINI)

Job Family : Research & Innovation, University Title : Sr. Clinical Research Coordinator 1, Job Code : 34114N

Salary Range : Commensurate with Experience, Up to $65,000

Position Details :

Department : Institute for Drug and Alcohol Studies

Employment Type : UF - University Employee FT

Restricted Status : Yes

FTE : 100

Exemption Status : Exempt