Senior Clinical Research Coordinator

About the Position

The Senior Clinical Research Coordinator (CRC) oversees and administers clinical research studies and associated activities. This position will assist with the development and management of study budgets. The Senior CRC will assist with the review of protocol requirements and assist with the collection of impact statements needed to properly assign costs to each assessment/procedure. The Senior CRC will provide feedback on the amount of time necessary for conduct staff to administer assessments and procedures as assigned during the budgeting process. The Senior CRC shall cooperate as necessary with the Geneva Corporate Manager to ensure that studies remain financially healthy, including but not limited to, the review of monthly budget reports as well as budget forecasts. The Senior CRC assists in project planning, and ensures that pre- established work scope, study protocol and regulatory requirements are followed. This position may recruit and coordinate research subjects, as appropriate, and serves as principal administrative liaison for the project. This position oversees and coordinates the provision of administrative and staff services to investigators; develops and maintains record keeping systems and procedures. The Senior CRC may also assist with the preparation of presentations for required review and approval processes, to include public
affairs office review as applicable.

About the Project

This position will support multiple research projects under the MIRROR program. Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) delivers high value research, education, training, and infrastructure for over 40 clinically relevant musculoskeletal injury (MSI) studies within the military health system (MHS). MIRROR supports a broad scope of projects, including epidemiological investigation, investigator initiated pilots, and prospective randomized multisite clinical trials. Areas of clinical evaluation comprise general MSI care process models and highly prevalent anatomically-specific (e.g. back, knee, shoulder pain, etc.) targeted interventions with protocols examining effective return-to-duty activities. These studies particularly focus on deployment-limiting MSIs, ensuring that research addresses the challenges faced by service members in maintaining operational readiness. Results of these studies generate evidence-based approaches for future clinical practice guidelines as well as educational opportunities for future military and civilian providers at WRNMMC and USU.

Compensation: $85,000 - $110,000

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
• US Citizenship required to work at this government site
• 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
• AdheretoOccupationalSafetyandHealthAdministration(OSHA),GoodClinicalPractices (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.