Clinical Trial Coordinator (CTC) Date:Oct 10, 2018 Location:Upper Gwynedd, PA, US -Requisition ID:CLI007981 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified itslegacy for over a century. Mercks success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck is on a quest for cures and is committed to being the worlds premier, most research-intensive biopharmaceutical company. Today, were doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Mercks leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. This role is responsible for comprehensive trial and site administration. Under the oversight of the Clinical Research Manager (CRM) the individual prepares, collates, distributes and archives clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable. The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at the local level closely with COM, CRM and CRA. And the individual may collaborate with finance/budgeting representatives to manage CTRAs and payments. Responsibilities include, but are not limited to: -Trial and site administration: -Track (e.g. essential documents) and report (e.g. Safety Reports) -Ensure collation and distribution of study tools and documents -Update clinical trial databases (CTMS) and trackers -Clinical supply & non-clinical supply management, in collaboration with other country roles -Manage Labeling requirements and coordinate/sign translation change request -Document management: -Prepare documents and correspondence -Collate, distribute/ship, and archive clinical documents, e.g. eTMF -Assist with eTMF reconciliation -Execute eTMF Quality Control Plan -Update manuals/documents (e.g., patient diaries, instructions) -Document proper destruction of clinical supplies. -Prepare Investigator trial file binders -Obtain translations of documents -Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to: -In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions -Obtain, track and update study insurance certificates -Support preparation of submission package for IRB/ERC and support regulatory agencies submissions. -Publish study results for GCTO and RA where required per local legislation -Budgeting, Agreement and Payments -Collaborate with finance/budgeting representatives for: -Develop, control, update and close-out country and site budgets (including Split site budget) -Develop, negotiate, approve and maintain contracts (e.g. CTRAs) -Track and report contract negotiations -Update and maintain contract templates (in cooperation with Legal Department) -Calculate and execute payments (to investigators, vendors, grants) -Ensure adherence to financial and compliance procedures -Monitor and track adherence and disclosures -Maintain tracking tools -Meeting Planning: -Organize meetings (create & track study memos/letters/protocols) -Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable) FTP2019 FTPMRL2019Qualifications Education Minimum Requirement: -B.A./B.S. (Life Science preferred) Required Experience and Skills: -A minimum of participation in at least 1 Merck Internship -CORE Competency Expectations: -Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills -Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. -Hands on knowledge of Good Documentation Practices -Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required. -ICH-GCP Knowledge appropriate to role -Behavioral Competency Expectations: -Effective time management, organizational and interpersonal skills, conflict management -Effective communication with external customers (e.g. sites and investigators) -High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment -Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. -Demonstrates commitment to Customer focus, both internally and externally. -Able to work independently -Proactive attitude to solving problems / proposing solutions Preferred Experience and Skills: -1 - 2 years in Clinical Research or relevant healthcare experience Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and were counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, were inventing for life. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to -. Search Firm Representatives Please Read Carefully: Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position. For more information about personal rights under Equal Employment Opportunity, visit: -Merck is an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations. Job:Clinical Research Generic Other Locations:US Employee Status:Regular Travel:Yes, 10 % of the Time Number of Openings:9 Shift (if applicable): Hazardous Materials: Company Trade Name:Merck