Our objective is to launch long-term, successful relationships between the individuals we place and our clients. That is what makes Accord Scientific an industry leader. To apply for any of the opportunities listed below, fill out the online application. Please include an updated version of your resume, along with the job ID number(s) you are interested in.
| Job ID: | 09112092652 |
| Location: | Raleigh, NC |
| Category: | Associate Clinical Project Manager |
| Description: | Job Description Accountable for planning, coordination and supervision of all monitoring and site-related operational activities of one or more clinical studies from protocol summary through study report, including trial master file archiving and other operational post-report activities. Provides operational support to the CPM to deliver the project within planned timelines and according to required standards of quality and compliance. Major Accountabilities Lead, train, track, and coordinate activities of the monitoring team to execute studies (predominantly phases IIIb/IV) in the required countries to deliver timely and high quality study data. • Oversee all study related site management and monitoring activities including review and follow up of monitoring visit reports and study-related accompanied site visits. • Review and approval site regulatory package. • Proactively manage compliance and quality issues. • Assist in site contract issues and follow up where needed • In collaboration with CPM/Study Team, ensure that the study is audit/inspection ready at all times and any resulting findings from audits/inspections are addressed appropriately and in a timely manner. • Generate study documents (eg Patient Information Sheets, Informed Consent Forms, CRFs, Monitoring Manual, and associated tools) and coordinate translations • Review and give input into Protocols, Amendments, Clinical Trial Reports, and other trial related documents. • Manage, review and ensure quality of content of Trial Master File including archiving. • Support CPM in management of trials including but not limited to vendor selection and management • training • logistics • selection of site • maintenance of tracking systems • follow up of missing SAE data • Coordinate IEC/IRB submissions. Prepare or review responses to questions from regulatory authorities, and IECs/IRBs. • May perform duties described in the CPM job description (see Appendix) with oversight as necessary, according to competence level • Ensure quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices. • Travel including overnight stays, possibly global, required. • Perform other tasks as deemed necessary by the Company • Perform Co-monitoring activities with the CRA/CSMs and generate follow up reports Education B.S. (or its equivalent) in a life science/biological or health related field required. A higher-level relevant qualification is preferred. Experience • At least three years’ relevant experience in clinical development preferably including team leadership and monitoring experience • Experience or capability to manage in-house and/or outsourced regional monitoring in global Phase IIIb/IV multicenter clinical studies from study start-up to archiving of the trial master file Specific skills • Team leadership and motivation of individuals on international teams • Operational task management • Delivery of presentations and training to both large and small audiences • Excellent verbal and written communication in English • Proficiency in the Microsoft office suite • Good interpersonal skills • Excellent time management and organizational skills • - Scientific and technical knowledge: - GCP and regulatory environment - Basic medical and research knowledge - Basic principles of data management and statistics Problem solving • Proactive approach, drive and follow through • Managing multiple concurrent responsibilities in an environment of changing priorities without close supervision. • Ability to handle detailed technical matters and team dynamics. • Reconciliation of conflicting priorities. |
| Job ID: | 091119103958 |
| Location: | Franklin, TN |
| Category: | Document Control Associate |
| Description: | General Description The Document Control Associate is responsible for all the daily operation of Document Control. The ideal candidate will be a self-starter and a highly motivated team member with the ability to prioritize and multitask. This individual will have the ability to work independently and as part of a team and possess a strong customer service focus. Coordinate and lead the activities of Document Control, including distribution and auditing controlled documents, maintenance of electronic department directories, tracking and reporting on document review progress. Work independently to facilitate group activities. Reporting to the Senior Manager of Document Control and Learning Serivices, this position supports document control and training functions to ensure proper control, maintenance, improvements and general support. The focus of this position is to maintain and coordinate procedures and associated forms used to manage the company's quality systems documentation program. This documentation program includes the FDA's Quality System Regulations (21 CFR Part 820) as well as 21 Parts 210,211, 11, ISO 13485, and ISO 9001. Duties and Responsibilities - Maintain the Quality System files in compliance with 21 Part 820, 210, 211, 11, ISO 13485, and ISO 9001. - Manage archival activities by ensuring proper upkeep of Quality System documents. - Manage the creation, customization, and process qualification of forms for an electronic documentation system (i.e. MasterControl). - Provide support to all employees on document control issues (i.e. electronic Documentation System). - Assist with the management and administration of the department document control system. - Work with subject matter experts on technical subjects in a positive, collaborative manner to prepare controlled documents which conform to set format. - Review and proofread documents for consistency of document format and system concerns. Ensure accurate and timely release of all document changes. - Assign various document tracking numbers. Use department databases to track and manage and control issued documents. - Effectively follow SOPs, internal policies, industry requirements (i.e. cGMPs, ISO standards etc.). Provide support for the Quality System during corporate audits, actively participate in department activities. - Adhere to and enforce policies and procedures related to document control. - Evaluate the current documentation system, provide gap analysis, complete gap, and improve Document Control by implementing a streamlined document system. - Accountable for the development, coordination, and maintenance of the company's Document Control System. - Coordinate document change activities between departments and prioritize Document control workload. - Assume responsibility for administrative duties related to documentationof procedures and practices (i.e. administrative changes to existing documentation). - Provide support including; documentation revision, distribution, and maintenance of all compliance documents. Requirements Bachelor's degree preferred; advanced certifications required for advancement Experience Some working knowledge in procedural writing and documentation requirements is beneficial. Working knowledge and/or training in quality standards, such as ISO 13485, ISO 9001 or FDA Quality System Regulations is preferred, but not required. Technical duties - Develop a system to track and trend documents - Maintain a Documetn Control Database for labeling, QS documents, file room, standards etc. - Maintain a secured Document Control folder for Doc Control daily functions - Administrative role in an electronic documentation system (i.e. MasterControl) Additional Helpful Requirements - AMES - Create a File (filing system) - Working with a documetation system - Good Manufacturing Practices Standards - Good Laboratory Practices Standards - Good Clinical Standards - Standards and standard setting bodies to include: 1. ISO 2. AAMI 3. ASTM 4. ICH 5. USP Skills - Excellent organizational skills - Ability to multi-task - Attention to detail |
| Job ID: | 09052721035 |
| Location: | Rome, GA |
| Category: | Clinical Research Coordinator, Cardiology |
| Description: | We are currently recruiting for a Clinical Research Coordinator in Cardiology with a solid work history and background in clinical research for a growing client of ours located in Rome, Georgia. The need is Immediate. This is a great opportunity with a growing clinical research institute that is focused on clinical research trials for the pharmaceutical industry mainly in the area of oncology, but also has focus on cardiology. This is a full-time permanent position with great compensation, benefits and relocation is provided for the right candidate outside of the Rome, Georgia area. Listed below are the main responsibilities and requirements for the position and what we are looking for in a candidate. Clinical Research Coordinator--Cardiology We are seeking an individual with cardiology research experience to help develop and build a new cardiology research line of business in conjunction with a growing medical center located in Rome, Georgia. Job Responsibilities: •Primary responsibility is to screen, enroll and follow study subjects ensuring protocol compliance and close monitoring while the subjects are on study. •Responsible for all data collection, source documentation, completing study specific case report forms, and submission of adverse experience reports. •Need to have experience with GCP and ICP guidelines and regulatory documentation. •This position will work closely with the Principal Investigator and other research study team members. Job Requirements and Qualifications: •BS in nursing, pharmacy or other related science or combination of equivalent education and experience. •Cardiology research experience required. •RN required •Research Professional Certification – CCRP or exam eligibility certification preferred |
| Job ID: | 080716162946 |
| Location: | Nationwide - Regional |
| Category: | Clinical Research Associate (CRA) |
| Description: | This is a great opportunity with a growing biopharmaceutical company that is focused on the development of oncology and critical care products related to men’s health. It is a position with great compensation, benefits, and relocation is provided for the right candidate. Listed below are the main responsibilities and requirements for this position and what we are looking for in a candidate: Position Summary: The Clinical Research Associate will be responsible for operational activities related to a specific clinical program resulting in clinical studies being conducted in a successful manner. The Clinical Research Associate will help with initiating, coordinating, tracking, maintaining, and reporting on all clinical study site documentation. Will serve as liaison among site, vendor, and company Clinical Operations team. Maintain and organize site-specific central files. Main Job Responsibilities: •Project Team audits of regulatory files and other study documentation •Review data management issues and follow-up with sites as necessary •Attend monitor conference calls •Create and distribute monitor conference call agenda and minutes •Attend data management conference calls •Conduct monitoring visits per company standard operating procedures at selected sites •Central vendor report review and reconciliation •Develop and maintain protocol-specific internal tracking logs as needed •Review and reconcile Serious Adverse Event reports for follow-up and reconciliation with coordination of Safety. •Assist in the development/review of study related documents such as informed consent, protocol, protocol amendments, source documents, case report forms, case report form instructions, data management guidelines, study manual, instructional materials, monitoring trip reports, study newsletters, etc. •Assist in the management of site communications regarding protocol, eligibility and/or medical questions, etc. Interact with Medical Monitor, as necessary •Work with Clinical Trial Specialist to authorize study drug shipments to investigative sites based on approval of regulatory document packages •Assess study drug inventory for all sites and authorize additional shipments as needed Education and Experience: •B.S/R.N degree in the scientific or health care field (e.g. nursing, pharmacy, medical, etc) or B.A. •At least 3 years of clinical research experience (Phase I, Phase II, Phase III and Phase IV), preferably in pharmaceuticals; knowledge of GCP guidelines/regulations and FDA standards •Demonstrated verbal and written communication skills are essential. •Strong attention to detail is required. •Ability to manage and prioritize activities in conjunction with multitasking skills. •Strong demonstrated organizational skills. •Ability to work independently as well as in a team environment. •Must have strong computer skills using Microsoft Office Suite. •Must be able to build good rapport with site personnel and other colleagues. •Needs current Passport or ability to get one. •Bilingual (Spanish) helpful. |