Clinical Research Coordinator

Position Details

• Schedule: Full-time (40 hours/week)
• Location: Hybrid
• Salary Range: Starting range $60,153.60 - $69,180.80/year (Where an applicant may fall on the salary range will vary based on a variety of factors, including but not limited to experience & education)

Benefits

• Health Coverage: Medical, Dental & Vision Insurance 
• Retirement: 401(K) with Company Match, Profit Sharing
• Time Off: Generous PTO, Holiday Pay, Floating Holiday
• Disability Coverage: Short & Long-Term Disability
• Family Support: Paid Leave and Disability
• Performance Incentive: Discretionary Bonus Based on Company, Department, and Individual Goals

Key Responsibilities 

General Administration:

• Coordinate with PI and Department Manager to ensure that clinical research and related activities are performed in accordance with Federal regulations, GCP, MNGI policies and procedures, and sponsoring agency policies and procedures.
• Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, and execution of research plan. Maintain documentation of training.
• Assist PI to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with Federal regulations and sponsoring agency policies and procedures.
• Coordinate and facilitate monitoring and auditing visits. Notify appropriate organizational and sponsor agency officials of external audits by FDA and sponsors.
• Collaborate with PI and institution to respond to any audit findings and implement approved recommendations.

Protocol Preparation & Review:

• Review and comprehend the protocol.
• Attend investigator meetings as required or requested by the sponsoring agency.
• Prepare other study materials as requested by the sponsor. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Prepare applicable submission forms and submits updated documents.
• Create training materials for research PIs, Sub-Is and staff and facilitate documentation of training completion.
• Establish and organize study files, including but not limited to the study specific source documentation, the regulatory binders and other materials.

Conduct of Research:

• Review and develop a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
• Assist PI in communication of study requirements to all individuals involved in the study. Provide appropriate training and tools for study team members. Document date of training and signatures of study personnel trained on study specific training log.
• Work with the PI and Research Recruitment Specialist to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
• Conduct and participate in the informed consent process including interactions with research participants, answering any questions related to the study. Obtain appropriate signatures and dates on forms in appropriate places. Assure that amended consent forms are appropriately implemented and signed.
• Collect and review medical records for participants prior to randomization, as needed for safety reporting, and as requested by investigators.
• Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion in the study.
• Complete and document intake and protocol-specific procedures.
• Manage, dispense, and collect investigational product. Assess compliance and provide counseling.
• Complete and document investigator orders.
• Oversee recruitment activities and coordinate recruitment plan with Research Recruitment Specialist to ensure enrollment goals are met.
• Coordinate and schedule participants’ tests and procedures.
• Collect data as required by the protocol. Assure timely completion of Case Report Forms and resolution of data queries.
• Maintain comprehensive knowledge of protocol and study timelines.
• Maintain study supplies.
• Facilitate and work directly with the PI to manage the administration of investigational products to research patients as