A Global Pharmaceutical company located in Rockville, MD, who are in need of a Regional Lead, Company requires for minimum 5+ years pharmaceutical industry with previous experience as a Sr. CRA in a protocol lead capacity, Clinical Project Manager or Site Manager

IMMEDIATE RESPONSE!! INTERVIEW AND START ASAP

Are you interested in the CRA opportunity, but not available for traveling more than 25%? Please read on

Our exciting Lead CRA opportunities within our clinical group.  We are working with a biopharmaceutical company has assembled a strong pipeline of lead products in the areas of Cardiovascular, Renal and CNS located in MD/DC areas who is in need of  Sr. CRA/ Regional Lead to work on new Medical Imaging Agent studies including 4 existing trails -  two are global and 2 are domestic. Phases 2 and 3 are Cardio Renal, there is also a Phase 1 for Pediatric.

We are looking for qualified candidates with the urgency as the TMFs for the legacy trials will need to be transferred to their office database and we will need an in-house person to manage the files.

If you are not interested or available, please forward this ad to other Sr. CRA/CPM candidates!!

IMMEDIATE RESPONSE!! INTERVIEW AND START ASAP

Job Description is below. 

Responsibilities

• As a member of the clinical project team, provides CRO(s) and vendors oversight for managed clinical trials. This includes and is not limited to planning, organizing, communicating, and implementing study objectives for study protocols.
• As a member of the clinical project team, may be assigned responsibility for the management of oversight leads for US and potentially other countries.
• Primary contact for management of operational activities of vendors
• Participates in clinical team meetings.
• Prepares and or review a variety of documents including protocol, CRF, informed consent form, operations manual, monitoring plan, and other documentation required for the conduct of a clinical trial such as medical imaging manuals.
• Assist with the preparation of required regulatory documents, such as IND/NDA annual reports, updating of the IB, and final study reports for assigned protocol(s)
• Manages day-to-day clinical operations, including management of sites and coordination of team member activities for assigned study regions.
• Manages oversight monitoring for assigned study regions
• Initiates the development of a template site budget for management review and approval.
• Coordinate the completion of Patient Accrual Logs for Finance
• Participates in conducting meetings (i.e. CRA Training, Investigator, etc.), including advance preparation, presentations, problem resolution, and follow-up.
• Participates in development of training programs and training of affiliate and  CRO staff working under OPDC and other SOPs
• Reviews essential documents for completeness and accuracy and prepares all required documentation required for IMP release and ongoing trial master file maintenance.
• Performs qualification, initiation, interim and close-out oversight site visits in accordance with SOPs when applicable.  Train oversight CRA on these activities.
• Takes a lead role, under supervision of the Program Manager, to develop recruitment strategies and monitor enrollment to assure milestones are met.
• Identifies, analyzes, and reports serious compliance issues, and develops action plans for approval by management.
• Ensures continual availability, at each site, of clinical and non-clinical supplies necessary to meet study requirements.
• Reviews tables, listings, and study reports for assigned protocol(s).
• Reviews data listings, manages process, and facilitates data review from all sites. Tracks all decisions and items that come out for follow-up. Coordinates and ensures that all paper and/or electronic study related documents are appropriately filed for submission and inspection purposes.
• Trains clinical site personnel on the fundamentals of clinical trial management and regulatory requirements. Provides coaching and mentoring to peers as requested.
• Identifies and contributes to the resolution of project issues affecting the clinical conduct of the trial. 
• Anticipates study conduct issues and assists in developing contingency plans prior to study initiation and throughout the life of the trial.
• Conducts oversight visits of CROs and affiliates throughout the life of the trial and in preparation for inspection and/or achieve.
• Reviews and approves monitoring visit reports for all monitoring visits within assigned regions.
• Performs other duties as assigned, including continuing to successfully perform functional responsibilities of Regional Clinical Lead.

Knowledge/Skills/Abilities Required

• Bachelors preferred; or Associate degree in Allied Health with appropriate experience (e.g. RN, MT). 
• Minimum of 8 years clinical research experience with at least 4 years as CRA Lead, or Sr. CRA in a protocol lead capacity, Clinical Project Manager or Site Manager
• Cardio Renal experience preferred
• Strong working knowledge of GCP/ ICH and other applicable regulatory guidelines
• Proficient with document management practices relative to assuring quality of essential documents and other study-related documents
• Working knowledge of international regulatory practices and timelines for study initiation in various regions
• Working knowledge of investigational product management in multiple clinical trials
• Strong attention to detail and good organizational skills
• Solid oral and written communication skills with ability to communicate effectively and professionally with various clinical trial and site personnel
• In-house position with travel estimated at approximately 25%. Onsite 3-5 days per week. Must have flexibility with schedule to accommodate interactions with team members and sites globally.

Keywords: Senior CRA, Sr. Clinical Research Associate, In-House CRA, CRAIII, Contract CRA, Senior CRA, Lead CRA, Regional Lead, CRA Lead, Senior Clinical Research Associate, Clinical Project Manager, Site Manager, CPM, Clinical Study Manager, Clinical Operations Manager, Clinical Trials Manager, Lead Clinical Project Manager, Protocol Lead

I welcome any questions or suggestions you may have at this time and look forward to hearing from you or any referrals you may have to provide the best Sr. CRA/Project Manager for the positions outlined above.  Thank you for taking your time to read this ad.

To apply, please forward your updated resume (word document) to rchu@gesnetwork.com or call Rose Chu at #610-822-1256. 

Look forward to hearing from you.

Kind regards,

Rose Chu
Vice President, Pharmaceutical & CRO Services

Global Employment Solutions, Inc.
One Presidential Blvd. North, Suite 310
Bala Cynwyd, PA 19004
610.822.1256 phone
610.822.1210 facsimile
rchu@gesnetwork.com

http://www.linkedin.com/in/rosechu