The Clinical Research Coordinator participates in or leads day-to-day operations of clinical research studies conducted by a principal investigator. The Research Coordinator performs a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. The Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. This position may direct the work of junior staff, train personnel and direct the work of a Clinical Research Assistant as assigned. Additionally, this position may involve supervising junior staff, providing training to personnel, and overseeing the activities of a Clinical Research Assistant as required. P reference will be given to individuals with a background/degree in bioengineering and device work. Work Schedule: Monday-Sunday 9am-5pm Qualifications:Minimum EducationBachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required)Minimum Work Experience1 year 1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required)Functional AccountabilitiesResponsible Conduct of ResearchConsistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information. Uses research funds and resources appropriately. Maintains confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research AdministrationMaintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. Accurately creates, completes, maintains and organizes study documents. Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Reviews current literature to obtain information relevant to clinical research program, as directed. Attends study meetings, which could include overnight travel, as requested by principal investigator. Works well with other members of the research team and seeks and provides input when appropriate. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center. Participant EnrollmentEmploys strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan.Screens subjects for eligibility per the protocol and institutional policies.Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction.Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.Engages participants/LARs in the informed consent process according to institutional policies.Follows procedures for documentation of study payments and participation incentives.Study ManagementPlans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies. Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks. Suggests improvements to specimen handling processes, when needed. Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses. Registers and records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner. Coordinates, prepares for and responds to routine oversight body visits and audits. Performs query resolution and assists with addressing and correcting audit findings. Data CollectionCollects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources. Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents. Organizational AccountabilitiesOrganizational Accountabilities (Staff)Organizational Commitment/Identification Anticipate and responds to customer needs; follows up until needs are metTeamwork/Communication Demonstrate collaborative and respectful behaviorPartner with all team members to achieve goalsReceptive to others' ideas and opinionsPerformance Improvement/Problem-solving Contribute to a positive work environmentDemonstrate flexibility and willingness to changeIdentify opportunities to improve clinical and administrative processesMake appropriate decisions, using sound judgmentCost Management/Financial Responsibility Use resources efficientlySearch for less costly ways of doing thingsSafety Speak up when team members appear to exhibit unsafe behavior or performanceContinuously validate and verify information needed for decision making or documentationStop in the face of uncertainty and takes time to resolve the situationDemonstrate accurate, clear and timely verbal and written communicationActively promote safety for patients, families, visitors and co-workersAttend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance