Job Description : Key Responsibilities: Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution. May support the start-up phase. Exploits available hardware and software to support the effective conduct of the clinical project data review and capture Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator s Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. Coordinate end-to-end cross-functional project operations and multi-disciplinary activities to ensure that project deliverables are met Monitor progress of project activities and deliver frequent updates to the Clinical Project Manager. Involved in coordination with legal team to prepare and review and/or to execute agreements with investigators and vendors (Master service and/or amendment, CDA, NDA) Collaborate and liaise with study team members for project execution support as appropriate. If applicable, may be accountable for supporting the development of project, and subject recruitment plan on a per site basis. Negotiates investigator remuneration; prepares financial contracts between COD-Research and investigational sites and investigators. Ensures that payments are appropriately triggered to investigational sites. If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirements. Qualifications : Bachelor s Degree in scientific discipline or health care preferred. At least 2-3 years of independent on-site monitoring experience. Experience in all types of monitoring visits in Phase II and/or III (Oncology Preferred) Equivalent combination of education, training and experience may be accepted in lieu of degree. In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Strong therapeutic and protocol knowledge as provided in company training. Computer skills include proficiency in using Microsoft Word, Excel and PowerPoint and using a laptop computer. Written and verbal communication skills including good command of English language. Organizational and problem-solving skills. Effective time and financial management skills. Ability to establish and maintain effective working relationships with coworkers, managers, and clients. Ability to travel domestically as needed to study sites and for training and meetings. A minimum of 50% overnight travel may be required
Job Description : Key Responsibilities: Literature search to prepare, review, and finalization of any clinical/non-clinical document Review of feasibility and related request for proposal (RFP) study synopsis Review of clinical documents, not limited to protocol, informed consent documents, subject diary, clinical study report and similar other documents etc Preparation and review of medical monitoring plan Therapeutic training of all stakeholders and if applicable to the site team via in-person / virtual for safety reporting in clinical trials along with medical monitoring plan and safety monitoring plan Participation presentation in Subject Experts Committee (SEC) meeting, PI meet Site Initiation Visit etc Review medical data ie eligibility documents, periodic data listing of efficacy and safety variables along with completed CRF data and medical coding of essential study data Interacting with Investigators for patient eligibility medical monitoring activities Communicate various study related aspects with the stake holders ie study team at site, various regulatory agencies and sponsor s medical team Interaction discussion with KOL for medical inputs for all clinical documents, data monitoring committees and other regulatory requirements Assist in data analysis and identifying risks Review of IB, IMPD etc Review of clinical and non-clinical overviews and summaries Review of briefing documents for EMA, USFDA and other submissions for various filings ie MAA, NDA, 510(k), BLA, 505(b)(2) etc Address sponsor , sites , internal clinical operations team regulatory queries Review, author and update SOP and support in global initiatives for ensuring enhanced quality and compliance Qualifications : MD Pharmacology is mandatory Minimum 2 years of relevant experience Strong written and oral communication skills Self-motivated to work in CT environment as individual contributors