CLINICAL RESEARCH COORDINATOR
- Plans and coordinates the initiation of research study protocol, and the establishment of operating policies and procedures.
- Promotes research capacity building among community-based organizations and student groups.
- Prepares research ethics board applications
- Plans, implements, and maintains data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data.
- Recruits, instructs, and coordinates research subjects and/or volunteers, as appropriate to specific study objectives and work scope.
- Ensures the smooth and efficient day-to-day operation of research and data collection activities; acts as the primary administrative point of contact for internal research staff and as the principle operational liaison for other research organizations, funding agencies and regulating bodies.
- Coordinates the day-to-day activities of any technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives.
- Plans and coordinates the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity.
- Supervises and coordinates the provision of support services to investigators and researchers.
- Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies.
- Plans and coordinates regular advisory board and steering committee meetings.
- To implement quality control process throughout the conduct of the trial
CLINICAL RESEARCH ASSOCIATE
- developing and writing trial protocols (outlining the purpose and methodology of a trial);
- presenting trial protocols to a steering committee;
- designing data collection forms, known as case report forms (CRFs);
- coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects;
- managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs;
- identifying and assessing the suitability of facilities to be used as the clinical trial site;
- identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site;
- liaising with doctors/consultants or investigators on conducting the trial;setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product. Plus training the site staff to trial-specific industry standards;
- monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis;
- verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV);
- collecting completed CRFs from hospitals and general practices;
- writing visit reports and filing and collating trial documentation and reports;
- ensuring all unused trial supplies are accounted for;
- closing down trial sites on completion of the trial;
- discussing results with a medical statistician, who usually writes technical trial reports;
- archiving study documentation and correspondence;
- preparing final reports and occasionally manuscripts for publication
CLINICAL RESEARCH ASSISTANT
- Assist in the development and implementation of recruitment strategies to increase patient randomisation into the trial (eg investigator and research nurse meetings, update newsletters, advertising, and letters to GPs).
- Work with the CRA to update the Patient Tracking Database – which includes details of patient recruitment into clinical trials, each individual’s progress through the trial, payments due to investigators, total paid to site, adverse events and other relevant patient related information.
- Maintain a database that records details of clinical trial shipments, and in collaboration with the CRA ensure that there are adequate supplies of clinical trial material to meet project needs. Plan, order and distribute non-drug clinical trial supplies eg clinical report forms, diary cards.
- Responsible for logging in received CRFs and transferring data from the CRFs into the database.
- Assist the CRA during the preparation for the investigator study initiation meeting
CLINICAL RESEARCH ANALYST
- Review of various clinical trial protocols and source documents.
- Clinical trial data analysis, tagging and updating the database.
- Advise data management staff on trial parameters, database designs, and validation of critical data.
- Reports progress and changes in clinical trials.
- Statistical analysis and competitive analysis of trial results
DRUG SAFETY PHYSICIAN
- Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed product
- Ongoing safety surveillance and signal detection/analysis
Provide medical guidance to Drug Safety Associates and Specialists in medical aspects of drug safety
- Provide medical input in all required safety reports, such as –but not limited to – PSURs, Clinical Expert Statement, Investigator notification letters
- Review all documents assigned for scientifically relevant issues including drug safety
- Function as pharmacovigilance representative/safety leader/senior technical lead on the projects, in Proposal Development Team and/or client meetings
- Provide medical advice and support for the safety component of feasibility studies
- Provide safety input to Risk-Management Plans, Pharmacovigilance Strategy and to the overall analysis of the benefit-risk balance of marketed or investigational products
- Support of Medical Directors as required
- Support of the QPPV
DRUG SAFETY ASSOCIATE
- Receive, follow-up and report adverse events
- Review and process adverse events reported by Investigators
- Prepare Safety report as per Schedule-Y format to be reported to regulatory authorities and also other Investigators, who are part of the study
- Research and provide medical and scientific information to health care professionals and to various functional areas within the company
- Conduct and analyze, medical and scientific literature searches using critical judgment and professional / scientific expertise to support projects or queries
- Review clinical trial protocols, bioequivalence study protocols and provide inputs, support the clinical trial team
- Generates concise, accurate and well-written case narratives
- Responsible for effective and efficient development of the safety management plan, including development of specific processes to assure consistency within the project
- Effectively maintains the safety database and corresponding entry guidelines, including accurate entry of data and assurance of quality of data through quality control process
- Performs consistent coding of diseases, adverse events, and medication according to the project-specific coding conventions
- Supports the generation of Annual Safety Updates, Periodic Safety Reports, and other cumulative safety reports including data retrieval, analyses and quality control
- Reconciles SAEs in accordance with project specific guidelines
- Represents team at client meetings; contributes presentation of safety process at investigator meetings
- Responsible for ensuring that all Medical Review cases are processed in line with the SOPs and timelines as per the SLAs.
- Plan, organize, and manage daily work to meet service level timelines and deliverables. Perform daily responsibilities in accordance to all applicable Standard Operating Procedures (SOPs), conventions and UCB policies.
- Review all forms and documents pertaining to a case for errors, missing information, legibility.
- Provide guidance to the team members on the expedited cases.
- Provide medical input on difficult adverse event cases.
- Review and quality control of the serious and expedited cases as well as non serious cases.
- Responsible for submitting the final version of the Aggregate Safety Report to the client.
- Ensure US drug safety reporting regulations, ICH guidelines, and Client SOPs are applied by the team members to adverse event case reporting
- Evaluate team members’ adverse event case reports for performance improvement.
- Adjust to changing regulatory environment.
Q What professional bodies and organisations do our students and graduates link to?
Social media networks, such as LinkedIn (including LinkedIn groups), Facebook and Twitter can provide roads for students and graduates to keep up-to-date with current industry knowledge and ‘best practice’, networking opportunities, industry-related events and job vacancies.