Amarex Clinical Research

Clinical Research Associates (CRA)

Office based in our Germantown, MD. headquarters.

Must be willing to travel 70% on average.

MINIMUM QUALIFICATIONS:
Bachelors degree in a scientific or health related discipline. Must have at least one year of on-site monitoring of clinical trials. Strong knowledge of GCPs, FDA regulations and ICH guidelines, protocol development and CRF design. Excellent planning, organization, problem solving skills. Strong verbal and written communication skills. Computer literacy with Microsoft office software required. Ability to work independently.

CRA - Regional

Regional, home-based. Able to cover sites in the mid-west and Canada.

Must be willing to travel 70% on average.

MINIMUM QUALIFICATIONS:
Bachelors degree in a scientific or health related discipline. Must have at least one year of on-site monitoring of clinical trials. Strong knowledge of GCPs, FDA regulations and ICH guidelines, protocol development and CRF design. Excellent planning, organization, problem solving skills. Strong verbal and written communication skills. Computer literacy with Microsoft office software required. Ability to work independently.

Logistics Administrator

POSITON SUMMARY:
The logistics administrator is responsible for fulfilling the administrative needs of the Clinical Department and for other departments as needed.
RESPONSIBILITIES:
• Format, proof read and edit documents.
• Sort, organize, maintain and track documents and files. Route, track, and correct/track changes in .
documents for internal and external review circulation. • Perform auditing, data entry, word processing and filing..
• Coordinate and schedule business meetings. Prepare and distribute meeting agendas and meeting minutes.
• Manage, track, receive, and file site regulatory document requests, which may include scanning documents to be maintained electronically.
• Spreadsheet and database creation and maintenance (e.g., study trackers, study contacts, site-specific regulatory documents, metrics, etc).
• Prepare binders and manuals for various meetings and study-related purposes.
• Order, distribute, and maintain all study related material (e.g., diaries, CRF, SIV binders, Operations Manuals, site Regulatory Binders, etc). Track pass-thru costs for study supplies.
• Basic financial tracking, invoice circulation, and filing for investigator grants, vendors, etc.
• Distribute internal policies, procedures, and training materials.
• Communication with sites and other in-house support to CRAs or PMs, as needed.
• Maintain Clinical Department calendar to reflect meetings, monitoring visits, teleconferences, etc.
• Act as back-up contact (phone and email) for CRAs or PMs, when they are traveling.
• Assist with transmittal of CRFs and DCFs.
• Maintain Clinical Department files, vendor files, and clinical site databases.
• Arranges business-related travel.
REQUIRED EDUCATION AND EXPERIENCE:
• Bachelors degree and one year of related experience or equivalent education and relevant experience.
• Strong verbal and written communication skills.
• Strong MS Office skills.
• Extremely detail-oriented with excellent follow-up skills.
• Ability to work independently with minimal supervision.
• Effective interpersonal skills, including the ability to work in a team environment, contributing to a collaborative work atmosphere.

Regulatory and Scientific Analyst

POSITON SUMMARY:
The Regulatory and Scientific Analyst performs all activities related to development, preparation, writing, reviewing and editing of integrated reviews of literature and related materials that summarize data from published papers and clinical studies for submission to clients, the FDA and other regulatory agencies. Participates in site selection and conducts other tasks as assigned.
RESPONSIBILITIES:
• Write technical reports summarizing scientific papers and clinical/non-clinical study reports.
• Write clinical study reports and coordinate document preparation for submission to regulatory agencies, including IND, NDA, IDE and PMA items.
• Assist in reviewing, developing, writing, and/or editing Investigator Brochures, annual reports and clinical protocols.
• Prepare and integrate tables, graphs, and graphics for all documents.
• Responsible for creating and editing all sections of IND and NDA documents/submissions.
• Prepare and submit regulatory filing (DMF, IND, BLA, PMA, 510k) and supports program for electronic formatting of regulatory submissions.
• Review reports, tables and listings for completeness and accuracy.
• Interact with various departments to collect information and synthesize it into documents.
• Develop procedures for new projects and provide guidance to other personnel or consultants.
• Write study protocols with reference to current research and FDA guidelines.
• Keep updated guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents, including ICH Guidelines.
• Act as a member of study teams, clinical project teams and interdepartmental project teams.
• Work with outside and internal database managers and statisticians to obtain data listings and analyses needed to support the preparation of Clinical Study Report/ publications.
• Other duties as assigned.
REQUIRED EDUCATION AND EXPERIENCE:
• MS/PhD degree with experience in publishing scientific papers in peer-reviewed journals.
• Two plus years experience in writing and preparation of clinical study reports phase I thru III and regulatory submissions is preferred.
• Strong presentation skills.
• Strong verbal and written communication skills.
• Strong analytical skills.
• Strong Microsoft Office skills particularly in MS Word and Excel.
• Extremely detail-oriented with excellent follow-up skills.
• Ability to work independently with minimal supervision.
• Effective interpersonal skills, including the ability to work in a team environment, contributing to a collaborative work atmosphere.