Clinical Research Coordinator at Mid Atlantic Retina in Bethlehem, PA, USA

Job description

• Mid Atlantic Retina is one of the largest retina practices in the area, offering bonuses, top pay and growth opportunities for employees to not just work a job, but build a career. As a Research Coordinator, you will be responsible for coordinating all aspects of Mid Atlantic Retina's phase 1 through phase 4 clinical research trials.

Responsibilities

• Maintains a solid understanding of objective (primary and secondary endpoint) and rational of study.
• Obtains written informed consent and ensures all documentation of processes.
• Maintains awareness of regulatory need for study and ensures completion of action items.
• Reviews 1572 and delegation logs prior to start of study.
• Provides guidance to ancillary staff (Photographer, OCT Tech, BCVA, Receptionist, unmasked personnel) to make sure protocol is properly completed and any action items are completed. Communicates with them proactively throughout the study.
• Understands inclusion and exclusion criteria as they relate to study objectives, patient safety and retention of patients for valuable data.
• Informs subjects of any study changes including risks and signs amended informed consents.
• Collaborates with Screening Department in order to initiate a screening packet within the time frame for enrollment.
• Determines required visits and protocol agendas.
• Enrolls and retains patients in all assigned clinical trials.
• Manages clients within protocol parameters to ensure patient safety and the collection of valuable data and keeping protocol violations to a minimum.
• Completes clear, concise documentation of source documents following sample source SOPs to compliment data in CRFs in a timely manner.
• Records all communication in source or regulatory file.
• Communicates proactively with sponsors and CROs and assures all action items are completed in a timely manner.
• Boosts enrollment by informing doctors of study details, competing chart reviews and utilizing supplemental material.
• Responds to referrals within 24 hours.
• Completes all DCFs and ECRFs in a timely manner (within 7 days of visit).
• Works with CRAs, Medical Monitors and/or other personnel who are instrumental in answering questions, as well as building a professional rapport that can help in the successful undertaking and completion of study.
• Transports clinical specimens to lab or arranges for specimen pick up.
• Follows all FDA/GCP regulations.
• Responsible for all regulations for assigned clinical trials.
• Cross-covers for other Coordinators as needed.
• Telephone screening of patients.
• Regular and predictable attendance required.
• Works overtime as needed.
• Travels as needed.
• Performs other duties as assigned.

Requirements

• College degree in related health science or 2 years Clinical Research work experience.
• Desire to work with patients

Skills

Required

• Desire to work with patients

Benefits

• 401(k) & Profit Sharing
• Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• Short & Long Term Disability
• Paid Time Off
• Bonuses