Responsibilities include: *Performing site visits to monitor and ensure study/protocol compliance according to GCPs/ICH, and other regulatory agency guidelines; *Ensuring that the rights, well-being and safety of human subjects are protected; *Assuring that the reported data is accurate, complete and verifiable from source documents; *Maintaining ongoing and continuous professional communication with the clinical site and the study team. *This position is Regionally based out of NY, NJ, or PA or surrunding states and needs to located near a major airport as this position requires 60%-70% travel.

Requires: Bachelor’s Degree in health sciences or related field. Minimum 2 years CRA/Monitoring. Willingness to travel.

Responsibilities include: performing site visits to monitor and ensure study/protocol compliance according to GCPs/ICH, and other regulatory agency guidelines; Ensuring that the rights, well-being and safety of human subjects are protected; Assuring that the reported data is accurate, complete and verifiable from source documents; and maintaining ongoing and continuous professional communication with the clinical site and the study team. This position is Regionally based out of Texas.

Requires: Bachelor’s Degree in health sciences or related field; Minimum 2 years CRA/Monitoring. Willingness to travel.

Monitoring of clinical trial investigative sites to ensure study protocol compliance according to GCP/ICH guidelines including: ensuring informed consent procedures are followed, serious adverse events are reported, performance of drug accountability, review of case report forms to ensure source data is accurate and verifiable, and ensuring essential regulatory documents are present and up to date; also may be asked to assist in the completion and collection of regulatory documents. Successful candidate should have experience conducting pre-study visits, site initiations, interim monitoring visits and close-out visits and be experienced in overall site management. Responsibilities will also include ongoing and continual communication with the clinical site and study team/personnel throughout the duration of the study.

Bachelor’s Degree in health sciences or related field plus a minimum of 2-4 years (for CRA) or 4+ years (for Senior CRA) on-site monitoring experience. Integrium utilizes a decentralized model and therefore, candidates must be able to travel approximately 60-70% of the time. Must be detail-oriented with excellent oral, written, and interpersonal communication skills and must demonstrate exceptional mentoring and leadership skills. Must be computer proficient. Cardiovascular experience a plus. Additional Responsibilities for Senior CRA: Will be expected to perform in a leadership capacity which would include: effectively communicating study objectives, timelines, and other related information to the clinical investigative site staff and study team, assisting in the training and mentoring of CRAs and assisting the Project Manager in preparation of CRA tools and monitoring plans to be used in the conduct of the trial.

The Business Development Director is responsible for securing new business from pharmaceutical, biotech, and device companies within Integrium’s target market in the assigned territory. They will have ownership within their territory of the process of leads identification and prospecting, and generating interest in Integrium’s capabilities. This will include actively seeking and conducting meetings and presentations with potential clients. The BD Director will have a pivotal role in responding to requests for proposals and proposal defense meetings, and will coordinate closely with Integrium’s operations and contracts teams in this process. They will also work closely with assigned current clients in securing repeat business. The BD Director will be responsible for promoting Integrium’s name within the industry - both in developing and executing strategies in support of this effort.

Requried Education and Experience: 1.Degree in Life Sciences, Business or Marketing required. 2.Relevant marketing and business development experience in the clinical research industry, biopharmaceutical industry or healthcare industry. 3.Ability to work under a sales metrics structure with well-defined goals and delegated responsibility to meet those goals 4.Familiarity with Contact Management Systems 5.Ability to profile the needs and preferences of prospective clients and integrate this information into selling strategy 6.Strong presentation skills 7.Aptitude and interest to stay current on advances in product development and trends in the clinical research industry, and leverage this knowledge in communicating with clients

The Business Development Director is responsible for securing new business from pharmaceutical, biotech, and device companies within Integrium’s target market in the assigned territory. They will have ownership within their territory of the process of leads identification and prospecting, and generating interest in Integrium’s capabilities. This will include actively seeking and conducting meetings and presentations with potential clients. The BD Director will have a pivotal role in responding to requests for proposals and proposal defense meetings, and will coordinate closely with Integrium’s operations and contracts teams in this process. They will also work closely with assigned current clients in securing repeat business. The BD Director will be responsible for promoting Integrium’s name within the industry - both in developing and executing strategies in support of this effort.

1.Degree in Life Sciences, Business or Marketing required. 2.Relevant marketing and business development experience in the clinical research industry, biopharmaceutical industry or healthcare industry. 3.Ability to work under a sales metrics structure with well-defined goals and delegated responsibility to meet those goals 4.Familiarity with Contact Management Systems 5.Ability to profile the needs and preferences of prospective clients and integrate this information into selling strategy 6.Strong presentation skills 7.Aptitude and interest to stay current on advances in product development and trends in the clinical research industry, and leverage this knowledge in communicating with clients

The Sr. Clinical Study Coordinator (SCSC) works with Project Leaders (PL), Clinical Research Associates (CRA) and Directors to fulfill activities in support of one or more clinical trials in compliance with applicable regulations and Integrium standard operating procedures. *Performs routine regulatory document preparation, distribution, receipt, inspection and tracking for assigned clinical trials. *Liaise with CRAs and clinical sites regarding project clinical and regulatory issues. *Responsibilities may include training Clinical Study Coordinators (CSC) in collection and analyzing of data to produce reports. *High utilization of PC-based software packages for word processing, spreadsheets, and graphics. *Assist in scheduling internal and external team meetings. Attend team meetings and responsible for preparing the draft meeting minutes and agendas and reviewing and finalizing with the Project Leader *Organize travel arrangements and meetings. *Assist in study closure activities (e.g. facilitating query resolution, reconciliation of essential documents)

*Bachelors degree in Biology or related fields *Familiar with medical terminology and ability to train CSCs *Ability to work concurrently on several projects, each with specific instructions that may differ from project to project. *Ability to prioritize *Knowledge of ICH GCP and FDA regulations governing conduct of clinical research *Proficient in Microsoft Word, Excel, PowerPoint and Access *Excellent problem-solving skills. *Strong attention to detail and accuracy. *Strong commitment to quality. *Strong customer focus and flexibility. *Ability to successfully work independently and in a team environment *Excellent ability to communicate effectively and clearly both verbally and in writing *Exceptional organizational and time management skills and the ability to multi-task projects for timely completion

This position is a department head for the Medical Writing (Communications) Department. The individual will be responsible for creating and writing corporate SOPs for the Medical Writing department, interviewing and selecting staff in cooperation with Human Resources, leading a team of Medical Writers for all medical communications for Integrium, LLC.

*Education Required: MD, PhD, PharmD preferred with a mininum MS in Life Sciences *Management Experience *8-10 years writing exp in the pharmaceutical/biotechnology sector. CRO Exp a plus. *Demonstrated ability to communicate effectively and clearly, both verbally and in writing. *Understanding of biostatistical methods and the ability to interpret and describe statistical data. *Strong attention to detail with proven ability to review, organize, interpret and summarize data. *Comprehensive knowledge of the drug-development process, associated guidelines (included FDA and ICH), and medical publishing. *Experience writing clinical study, reports (all phases), sections of an IND and NDA (CTD format preferred), including an ISS and ISE. eCTD experience is a MUST.

*Provides customer-focused leadership in managing multiple Phase I through Phase IV clinical research trials across functional areas. *Accountable for the successful completion of all assigned global and/or projects, where success includes all of the following: on-time, on-budget, in compliance with all applicable regulations, quality data and reports, satisfied customer. *Proposal development and bid defense for assigned RFPs and functions as an integral part of the selling team and is administratively responsible for assigned clinical staff. *Prepare and present regular analytical and metric reports regarding study status to Clients and to Integrium management. *Serve as a mentor for Project Leader within the Project Management function.

•BS/BA, RN, or equivalent; graduate degree preferred but not required. •5 or more years of qualified project management experience in a clinical research environment with demonstrated experience in all of these three areas of competency: • Staff management experience • Proven track record for the Management of complex budgets and time lines • Business development experience including proposal generation and bid defense with numerous successes resulting in significant business wins. • Negotiation and financial acounting • Knowledge of FDA regulatory requirements /guidelines (i.e. CFRs, ICH GCPs, etc.) is mandatory. • Previous technical and managerial experience in conducting multi-national and/or local clinical trials.