Weekend Clinical Research Regulatory Jobs in Decatur, GA

GI Care for Kids is hiring a Clinical Research Manager.
The Clinical Research Manager is responsible for supporting the needs of the clinical research department and the investigators. The Clinical Research Manager ensures that research conducted at the site is performed and conducted with highest ethical standards and adheres to all GCP and FDA standards. Along with managing the Clinical Research department, the Clinical Research Manager is expected to be able to conduct duties of a clinical research coordinator.

Essential Duties

• The Clinical Research Manager is the main point of contact with sponsors, CRO’s, and Laboratories.
• Reviews and completes Budget negotiations with sponsors and CRO’s for upcoming and active studies at the site.
• Coordinates with sponsors, CRO’s and GI Care for Kids’ legal team to ensure that clinical trial agreements are completed and executed in a timely fashion.
• Completes regulatory submission for study start up.
• Enters studies and budgets into the clinical trial management system.
• Coordinates with the practice bookkeeper that financials for the research department are ac-curate and ensures payment receipts.
• Coordinates with all departments of the practice to ensure that the Research Department follows and abides by the SOPs of the Practice.
• Creates and updates SOPs for the Clinical Research Department as needed.
• Communicates with physicians and staff on a regular basis regarding current research studies.
• Ensures all participating physicians’ trainings and certifications for research are current and up to date.
• Creates relationships with nearby physician practices and vendors for requirements of study protocols.
• Analyzes and reads protocols to determine if the protocols are suitable for the practice.
• Completes feasibility questionnaires for upcoming studies.
• Works with the physicians in the practice to determine interests in studies.
• Works with the coordinators and research staff to ensure that study enrollment goals are met according to contracts.
• Implements recruitment procedures to ensure enrollment goals are met per contract.
• Creates and sends invoices to sponsors.
• Ensures vendors for research projects are compensated.
• Schedules and coordinates site initiation visits with sponsors and PI.
• Ensuring all equipment for studies are calibrated and maintained.
• Serves as a back-up to coordinators.
• Coordinates with Principal Investigator and department to help ensure that clinical research and related activities are performed in accordance with ICH and GCP guidelines.
• Assists the 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 re-quirements, schedule of visits, execution of research plan. Maintains documentation of train-ing.
• Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the re-search project have met training requirements.
• Coordinates and facilitates monitoring and auditing visits.
• Collaborates with PI and institution to respond to any audit findings and implement approved recommendations.
• Reviews and comprehends the protocol.
• Attends investigator meetings as required or requested.
• Prepares and submits any IRB and any other regulatory submission documents as required by the protocol.
• Prepares other study materials as required. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
• Assists PI in communication of study requirements to all individuals involved in the study. Pro-vides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
• Works with other members of the research staff to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Coordinates research subjects’ tests and procedures.
• Collects data as required by the protocol. Assures timely completion of Case Report Forms.
• Maintains study timelines.
• Maintains adequate inventory of study supplies.
• Completes study documentation and maintains study files in accordance with sponsor and regulatory requirements.
• Retains all study records in accordance with sponsor and regulatory requirements.
• Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
• Process and collect lab samples according to IATA guidelines.
• Adheres to GCP and ICH guidelines at all times.

• Supervises clinical research coordinators and research assistants
• Guides and trains Clinical Research staff
• Ensures staff are completing study visits within windows and data entry is being completed with CTA windows
• Training of New employees
• Conducting regular meetings with staff to ensure departments needs and requirements are met.
• Completing annual evaluations of research staff
• Ensuring staff are using payroll system to maintain accurate records of time worked
• Making sure that the research staff are maintaining a clean and safe work environment
• Ensuring staff are following IATA in the processing and shipping of Biologic
• Ensuring staff Certifications are up to date and current