Qualifications

Bachelors degree or equivalent work experience required; masters degree preferred

8 years experience in clinical research preferred

5+ years non-profit, research, or healthcare experience desired

Certified Clinical Research Coordinator (CCRC) certification preferred

Demonstrated competence in oral and written communication

Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor

Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner

Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software

Knowledge of CFR, GCP and ICH guidelines

Management Responsibilities

May manage CRCs in entry-level to mid-level roles, research assistants, and other entry level to mid-level members of the conduct team, as assigned

The following management responsibilities are applicable to the Senior CRC in a supervisory role: Assist with staffing, hiring, salary negotiations and performance review process for conduct staff Conduct counseling, corrective action, up to and including termination, with Human Resources and Director Oversee programmatic/study related conduct ensuring staff perform tasks within scope of project Manage conduct staff to ensure optimal performance on each study Ensure staff demonstrate basic understanding of their job description Plan and facilitate individual and team meetings Assure all staff comply with Foundation and site policies, procedures and SOPs Proactively prepare and conduct site evaluation and study initiation visits Ensure sponsor and Geneva enrollment/milestones, study execution, and monitoring expectations are met on 100% of all studies Cognizant of and promotes networking opportunities with sponsors, subjects, and researchers

Responsibilities

Promote safety and confidentiality of research participants at all times

Adhere to Occupational Safety and Health Administration (OSHA), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and infection control procedures

Plan and coordinate the initiation of research study protocol, and the implementation of operating policies and procedures

Plan, implement and maintain data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data

Recruit, instruct and coordinate research subjects and/or volunteers, as appropriate to specific study objectives and work scope

Coordinate the day-to-day activities of technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives

Organize and facilitate meetings, conferences, and other events associated with research activities; may perform and/or coordinate outreach activities, as appropriate to research objectives

Document all correspondence and communication pertinent to the research

Interact and communicate effectively with Principal Investigator, other site personnel, research participants, The Geneva Foundation, and the funding organization

Comply with all the rules and regulations as applicable to assigned duty station

Create and adhere to a data quality and quality assurance plan

Assist with interim and annual reports. S/he will be the primary liaison at the data collection site and will be responsible for explaining the project to military personnel associated with the study

Demonstrate proficiency in performing basic study related procedures

Complete required and applicable research training needed to complete research

Maintain and update files of all applicable regulatory documentation for IACUC or IRB (including protocols, approvals, amendments, modifications, etc.) as well as any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc.

Manage study budgets to ensure that projects remain financially healthy and viable

Cooperative with institutional compliance and monitoring efforts related to the study(ies) and report instances of noncompliance to the PI and the institutional compliance office as appropriate. Coordinate and facilitate monitoring and auditing visits. Notify PI and appropriate institutional officials of external audits and inspections by FDA and sponsors.