Job Title: Clinical Research Coordinator Job Description Acts as liaison between principal investigators, sub-investigators, clinical research nurses, and regulatory specialists on all regulatory issues and changes within the protocol. In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting the study. Reviews study with principal investigator and/or clinical research nurses to outline a budget detailing standard of care and research costs. Finalizes budget draft with the budget coordinator. Responsibilities + Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. + Oversee subject enrollment to ensure that informed consent is properly obtained and documented. + Coordinate research activities including scheduling laboratory tests, radiology testing, and other medical exams as required. + Work with the study team to draft/create study-specific orders, billing templates, and study calendars as necessary. + Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols. + Monitor all study activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional policies. + Register protocol patients with appropriate statistical centers as required. + Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts. + Act as the principal investigator's representative as appropriate, including communicating with sponsors, the IRB, and other medical personnel. + Maintain accurate, complete, up-to-date records on each protocol and each patient participating in a clinical trial in the clinical trial management system and all other required systems. + Work closely with clinical research finance to ensure that study patient's clinical trial-related activities are billed appropriately. + Schedule, coordinate, prepare, and assist for all sponsor monitor site visits, ensuring all supporting documentation records are adequate and available for the visit. + Meet with monitors during site visits and resolve all issues found during the visit. + Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about incomplete data. + Ensure compliant maintenance of all required records of study activity including case report forms, drug dispensation records, or regulatory forms. + Oversee and direct the requisition, collection, labeling, storage, or shipment of specimens. + Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. + Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports. + Identify protocol problems, inform investigators of problems, and assist in problem resolution efforts such as protocol revisions. + Organize space for study equipment and supplies. + Participate in the development of study protocols including guidelines for administration or data collection procedures. + Contact outside health care providers and communicate with subjects to obtain follow-up information. + Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues. + Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions. + Attend research meetings and conferences as required. + Participate in staff meetings and in-service education as necessary. + Perform other duties and/or projects as assigned. Additional Skills & Qualifications + Excellent organizational and communication skills. + Strong attention to detail and ability to manage multiple tasks. + Proficiency in clinical trial management systems and other relevant software. + Knowledge of local, federal, and state regulatory and institutional policies. Work Environment The Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing, and compliant study conduct according to all relevant local, federal, and state regulatory and institutional policies and Standard Operating Procedures. This role carries out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which they are assigned. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.