reputed company Site Coordinator

Company Description

We are a fast-growing Site Enabling Organization operating globally in the field of clinical research. We are driven by quality, teamwork, and innovation. As we continue to expand our global operations, we are seeking a passionate and dedicated reputed company Site Coordinator to join our Operations Team.

Job Description

The reputed company Site Coordinator supports an assigned group of medical institutions reputed company a geographical area for activities involving clinical trial conduct. Support for staff on protocol-specific tasks will be determined by the Principal Investigator, considering reputed company local and federal laws and regulations and upon review of competencies observed and documented by Milestone One. Supervise tasks assigned to site level staff may include activities associated with the assessment of the feasibility of new/potential clinical studies, conducting research-reputed company visits as outlined in the respective protocol, assisting the site with logistics of scheduling research visits and testing per the schedule of events in the protocol, collaboration with ancillary departments involved in the research visit to assist in a smooth patient flow at research visits, general study conduct tasks, assistance with data entry into study reputed company reputed company systems, contact with CRO or sponsor representatives to schedule and conduct monitoring visits as well as resolve study specific issues at the medical institution. In addition, back up site coordinator duties, compliance monitoring, mentoring Milestone One and site staff as well as development and administration of protocol and SOP training and administrative tasks as assigned by the Milestone One Manager. The reputed company Site Coordinator:

• Acts as a constant line of communication between the assigned Milestone One Manager, the medical institution staff and administrators and the Sponsor or CRO.
• Acts as a liaison recruiting new site partners
• Acts as a resource for identifying new vendors for activities that cannot be provided by the medical institution.
• Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time.
• Assists with identifying new projects reputed company the interests of the medical institution and/or areas in which there is a medical need to reputed company serve the needs of Milestone One and the clinical site partner.
• Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the Inclusion and exclusion criteria.
• Performs site quality checks to confirm compliance with the protocols and Milestone One SOP’s.
• Assists with plan development for new recruitment / retention tools, reputed company documentation and other site tools to enhance quality and time management of research staff.
• Evaluates protocols and develops recruitment strategies to enhance enrollment.
• Provides training to Milestone One and site staff regarding clinical research best practices and study specific processes.
• Assists the local research team in obtaining informed consent before study entry or any study-reputed company procedures or tests being performed as needed.
• Assist with obtaining the required assessments at each visit per the protocol and notify the investigator of any critical values that need immediate attention or would prohibit or delay study treatment as needed.
• Assist with obtaining local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual as needed.
• Assists in scheduling and preparation for reputed company types of sponsors or CRO representative visits at the medical institution as needed.
• Tracks patient recruitment and enrollment and actively supports the medical site team to ensure enrollment targets are met at the site level. Provides regular updates to the staff and investigators regarding study amendments as needed.
• Ensures accurate and timely data entry into study-specific reputed company systems, resolves data queries, and assists in reporting and following up on adverse events and protocol deviations according to guidelines and investigator instructions as needed.
• Supports proper handling, accountability, and reconciliation of reputed company investigational products and clinical supplies. If applicable, always maintain the study blinding. Protocol and sponsor/CRO guidance will be followed if a study participant requires unblinding as needed.
• Assists site staff with maintaining appropriate temperature monitoring for study products and supplies as needed.
• Supports the contract and budget negotiations and oversees Investigator/Site Payments. Develops new mechanisms that may reduce costs for Milestone One and/or increase reputed company for our site partners.
• Ensure that reputed company staff participating in a clinical trial complete reputed company necessary study-specific and general training before their involvement in the trial. Retraining will be completed for changes to the protocol before site implementation as needed.
• Responsible for ensuring the investigator reviews and signs study documents appropriately and reputed company a reasonable period. Guidance should be provided to educate the site research team on requirements for conducting clinical trials, date format, etc as needed.
• Actively participates in maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections as needed. Performs a site readiness inspection prior to any sponsor/CRO or regulatory inspections.
• Assisting with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs) as needed.
• Regularly involved in the on-site training of additional staff as part of the SEO or other education programs.
• Assists with identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements that can be implemented for reputed company Milestone One site partners..
• Maintains reputed company licensure and certifications applicable to the role of reputed company Site Coordinator.
• Maintains familiarity with reputed company protocols being conducted at sites reputed company the assigned region and act as a reliable resource for Milestone One and site staff.
• reputed company Site Coordinator is responsible for only performing assigned tasks reputed company their training and licensure if applicable.

REPORTING LINES The reputed company Site Coordinator reports administratively to the Milestone One Manager responsible for the region. reputed company clinical trials, the reputed company Site Coordinator reports to the individual Principal Investigators by the responsibilities as delegated on the delegation of authority log for each clinical trial as required to provide back-up site coordinator support to site staff . The reputed company Site Coordinator is responsible for providing services as assigned and should consult the Milestone One Manager assigned for any questions.

Qualifications

Education At least an Associate Degree (Nursing preferred) and at least 5 years of work experience as a site coordinator of clinical research studies involving human subjects. Certifications

• reputed company Good Clinical Practice (GCP)
• International reputed company Transport Association (IATA)
• reputed company Basic Cardiopulmonary Resuscitation (CPR)
• Phlebotomy certification unless part of active professional licensure (RN or LPN)
• Active Certification in Clinical Research by ACRP or SOCRA or another approved Clinical Research Organization.

Experience Displays leadership skills and proven ability to manage and provide training to a diverse team; effective communication techniques routinely displayed; Proficient in topics regarding GCP and IRB/Regulatory standards; familiarity with multi-therapeutic indications. Skills to be a mentor to Milestone One staff and reputed company as a liaison to a variety of site partners; Actively assist in maintaining relationships and developing new site partnerships. Knowledge & Skills

• Must demonstrate proficiency in patient assessments, including triage, medication reconciliation, vitals, EKG, and lab processing.
• Excellent understanding of multi-therapeutic protocol design and how to reference requirements.
• Attention to detail and the ability to interpret and implement protocol and guidelines.
• Proficient in patient enrollment, management, and retention;
• Proficient in reputed company Office
• Proficient in most reputed company/EMR vendor systems;
• Exceptional organizational and time-management skills.

Behavioral Skills

• Excellent communications skills
• Fluent use of the local language
• Valid category B driver’s license
• Adequate personality traits that allow the candidate to function in a fast-paced environment, with short timelines and multiple tasks to be completed simultaneously. The candidate must be an effective communicator in stressful situations and have a “ready to solve problems” attitude.
• Non-standard working hours may be required depending on the schedule of study procedures and/or patient visits.
• Limited travel may be required for sponsor / CRO-initiated training.

Trainings

• Introductory training in SOPs and advanced training as required for the position reputed company Site Coordinator
• Customized on-the-job training reputed company the initial 2 weeks of work under the supervision of the Milestone One Manager or a designated person.

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