Clinical Research Recruitment Manager - 227530

PURPOSE: Clinical Research Recruitment Manager

Under the direction of the Site Lead, Clinical Research Manager, and Site Director, this position facilitates the execution of new studies and performs consistent and ongoing coordination of ongoing studies and maintenance of open and closed studies, as applicable. This position arranges and oversees all clinical study activities and recruits patients for clinical studies. This position works in close coordination with Site Leads, Clinical Research Assistants, Investigators, study monitors/Clinical Research Associates (CRAs), sponsors, Clinical Research Organizations (CROs) and the Compliance and Recruitment team to carry out the trial, as well as provide guidance on the administration of the compliance, financial and other related aspects of all ongoing clinical studies.

To work as an integral member of research staff maintaining the day-to-day relationship with sites and assist in the development of the network. This includes planning, coordinating and, as appropriate, execution of clinical studies in accordance with the protocol, contracted scope of work, ICH/GCP, Sponsor, CRO, and SOP’s and any relevant local guidelines and regulations.

RESPONSIBILITIES

• Coordinates with Principal Investigator (PI) and other research staff to help ensure that clinical research and related activities are performed in accordance with federal regulations and Standard Operating Procedures (SOPs).
• Assists the PI in development of materials and tools necessary to appropriately train research staff involved in the conduct of the study, related to (but not limited to) protocol requirements, schedule of visits, and execution of research procedures. Documents date of training and signatures of research staff trained on training logs.
• Cooperates with compliance and monitoring efforts and reports instances of noncompliance to the Site Lead or Research Manager (if no Site Lead).
• Coordinates and facilitates monitoring and auditing visits. Notifies Site Lead and Research Manager of external audits by FDA, sponsors, and Clinical Research Organizations (CROs).
• Collaborates with PI and to respond to any audit findings and implement approved recommendations.
• Attend and participate in investigator meetings, audits, seminars, and other regional or national meetings as required or requested.
• Works with the Regulatory team in the collection of study documents needed to initiate the study and submit to the sponsor, as needed.
• Organizes and maintains filing in all study files, including but not limited to, regulatory binders, study specific source documentation, and other materials.
• Coordinates and attends Site Initiation Visits (SIVs), Interim Monitor Visits (IMVs), and Close Out Visits (COVs).
• Reviews and develops a familiarity with the protocol, e.g., study procedures and timelines, inclusion and exclusion criteria, safety reporting, confidentiality, and privacy protections.
• Works with the PI and Site Lead or Research Manager (if no Site Lead) to develop and implement recruitment strategies in accordance with IRB requirements.
• Helps identify and recruit subjects into studies through pre-screening the investigators’ clinic Electronic Medical Records, thoroughly pre-screening advertisement patients, maintaining frequent communication with investigators about potential subjects, and weekly calling of potential subjects.
• Conducts or participates in the informed consent process including discussions with research subjects, including answering any questions related to the study. Obtains appropriate signatures and dates on informed consent forms (ICFs) in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Work with the Source Document Specialist and Site Lead on creation and updates of study specific source documentation templates utilizing the study protocol, study Case Report Form (CRF) or electronic CRF screenshots, SOPs and GDs, and other provided resources prior to the SIV as applicable.
• Identifies and implements updates to the study specific source documentation templates as needed throughout the study.
• Prepares study subject research binders by gathering, creating, and including necessary forms, logs, and study source document templates to prepare for subject enrollment.
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential subject’s eligibility or exclusion.
• Registers subjects to the appropriate coordinating center (if multi-site study), such as through the Interactive Web Response System (IWRS).
• Coordinates subject’s physical exams with appropriate study investigators and other tests and procedures required by the study protocol.
• Collects data as required by the protocol. Assures timely completion of Case Report Forms.
• Completes study documentation and maintains study files in accordance with sponsor requirements and SOPs and GDs including, but not limited to, consent forms, source documentation, case report forms, and investigational product accountability forms.
• Performs specimen processing and shipment of biological specimen duties.
• Maintains open communication with enrolled subjects to facilitate subject retention for the duration of the study.
• Perform functions necessary for successful completion of all protocol required visits/procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of investigational product, preparation and administration of investigational product, scheduling, drug accountability/reconciliation and organizational tasks, where appropriate and as delegated by the PI, in accordance with local country requirements and licensures.
• Accurately completes source documents and case report forms in both paper and electronic format.
• Performs timely submission of study visit data into the Electronic Data Capture (EDC) system, if applicable.
• Assists investigators with recording and reporting of adverse events (AEs) and Serous AEs (SAEs) within appropriate timeframes as per the study protocol, IRB, and local regulatory authority guidelines.
• Schedules study participant appointments and serves as the patient liaison to the PI and other participating investigators.
• Performs study visit reminder phone calls and text messages to study subjects for upcoming research appointments.
• Requests Medical Records, prints certified copies of Medical Records from investigators’ clinic Electronic Medical Records (if applicable), and extracts data from patient records in a timely manner.
• Distributes Dear Doctor Letters, informing research subject’s primary care physicians of their participation in the research study, as requested by the study subject.
• Responds to data clarification requests and queries in a timely manner, according to the study protocol and SOPs and GDs.
• Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or SOPs and GDs on Investigational Product Accountability.
• Maintains effective and ongoing communication with sponsor, CRO, research subjects, and PI during the course of the study.
• Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.
• Assists the PI in promptly reporting any unanticipated problems involving risks to research subjects or others to the IRB.
• Assists the PI in submission of accurate and timely closeout documents to the IRB, sponsor, CRP and other agencies in accordance with federal regulations and SOPs and GDs.
• Registers each subject visit in the Clinical Trial Management System (CTMS), Clinical Conductor in a timely manner to ensure billing of study procedures to the appropriate funding source.
• May perform other job-related duties as requested or required.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Sound knowledge of medical terminology.
• Sound knowledge of ICH/GCP and Regulatory requirements.
• Knowledge of good clinical practice (GCP), FDA and HIPAA policies and practices.
• Knowledge of International Air Transport Association (IATA) Dangerous Goods Regulations.
• Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors.
• Proficient in the use of Microsoft Office and Excel.
• Fluent in spoken and written English language.
• Strong organizational skills and meticulous attention to detail.
• Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
• Ability to maintain confidentiality.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.