Current postings

Clinical & Data Manager

Job duties include but are not limited to: Clinical data auditing and GCP compliance for clinical trials; working with SAS programmers and statisticians for development of Edit Specs and clinical data management plans; clinical data review; generating and resolving data queries; review of drug accountability; review, collection and maintenance of essential study documents and clinical site communication. Requires a B.S. or higher degree in Health and/or life Sciences field and 2 to 4 years of clinical research and clinical data handling experience.

Clinical Data Coordinator

MINIMUM QUALIFICATIONS:
Bachelor’s degree in the Life Sciences, Psychology, Sociology or related fields. Must be willing to travel. Strong MS office skills.

Clinical Research Associates (CRA)

Full time position in Germantown, MD. The candidate is responsible for the management of all assigned clinical research sites to ensure that studies are conducted in accordance with Good Clinical Practice (GCP), Food and Drug Administration (FDA) Regulations, International Conference on Harmonization (ICH) Guidelines, and Standard Operating Procedures (SOP). The candidate will participate in site selection, perform pre-study evaluation visits, site initiation visits, interim site visits and periodic telephone contacts to verify patient enrollment, protocol compliance, patient safety, case report form accuracy and legibility, and ensure that the study is progressing according to schedule. Perform Study Close-out Visits at the conclusion of the study.
MINIMUM QUALIFICATIONS:
Bachelors degree in a scientific or health related discipline. 2 plus yrs of clinical trials monitoring (Phases I through IV). Strong knowledge of GCPs, FDA regulations and ICH guidelines, protocol development and CRF design. Must be willing to travel. Excellent planning, organization, problem solving skills. Strong verbal and written communication skills. Computer literacy with Microsoft office software required. Ability to work independently.

Medical Writer

MINIMUM QUALIFICATIONS:
MD or MS degree or higher. 2 or more years of experience in development of clinical study reports for regulatory submissions.

SAS Programmer

MINIMUM QUALIFICATIONS:
Bachelors degree or higher. 3 plus years of extensive SAS programming experience in clinical trials. Database management experience preferred.

Statistician

MINIMUM QUALIFICATIONS:
Master degree or higher. 3 plus years of extensive experience in clinical trials. SAS Programming and Database management experience preferred. Strong knowledge of Guidelines for GCP and knowledge of ICH/FDA Regulatory requirements for clinical trials.