Research Specialist
Position Summary: The Research Specialist position is responsible for managing study-specific and departmental training, reviewing and executing Confidential Disclosure Agreements (CDAs) Non-Disclosure Agreements (NDAs) and/or transfer letters related to master CDAs. This role involves overseeing the routing of study contracts for signatures, coordinating the scheduling of sponsor visits, and maintaining the enrollment database to ensure accurate tracking of subjects.
Essential Duties and Responsibilities:
- Review and process CDAs, NDAs and transfer letters to ensure accuracy and compliance with institutional policies.
- Manage the routing and tracking of study-specific contracts for internal and external signatures.
- Schedule and oversee logistics for sponsor visits to include Pre-Site visits (PSVs), Site Initiation Visits (SIVs), Audit visits, Site tours, etc.
- Maintain and update enrollment and subject tracking databases (Access, G4, master enrollment spreadsheet, etc) to ensure data integrity and timely reporting.
- Serve as a liaison between internal and external stakeholders supporting each project.
- Managing all aspects of training documentation for department and protocols - this includes CITI, IATA and protocol specific training. This will require processing, scanning, archiving and ensuring documentation is complete and audit-ready.
- Managing collection of the yearly Financial Interest Disclosure for Research Forms and affiliated SOP.
- Assist research leadership with revisions of departmental SOPs.
- Interfaces externally with various levels of associates at other organizations, vendors, etc.
- Interface externally with pharmaceutical companies.
- Works closely with the Study Start-Up Specialist and serves as backup when required.
- Schedules and maintains calendar of appointments, meetings, events.
- Works independently and within a team on ongoing projects.
- Maintains a professional approach respecting the dignity and confidentiality of associates, managers, and vendors.
- Respects the dignity and confidentiality of patients.
- Maintains a good attendance record and reports on time for work.
- Maintains a professional attitude and appearance.
- Complies with clinic safety policies and procedures.
- Possesses good communication skills that lend to a team-oriented work environment.
- Attend staff meetings as scheduled.
- Assist with training and orientation of new employees as assigned.
- Interfaces internally with all levels of the organization.
- Performs all other duties as assigned.
Qualifications/Experience:
Minimum of 2 - 3 years of experience in clinical research or related administrative role.
Must have excellent organization and follow-up skills; excellent verbal and written communication skills; ability to understand basic scientific research and protocol; ability to analyze and interpret scientific data and skilled in the use of computerized systems and databases; ability to maintain the highest level of confidentiality - to handle sensitive material concerning the organization and the role of research within the organization; excellent problem-solving skills; ability to organize and prioritize work assignments; ability to handle multiple priorities in a fast-paced environment; ability to analyze situations and respond in a timely manner; ability to participate in multi-functional teams; ability to establish and maintain effective working relationships within The West Clinic; must be proficient in computer applications including Access, Excel, PowerPoint, Adobe Acrobat, strong internet research skills and e-mail. Additional hours may be required.
Work Environment/Physical Demands/Travel:
- Typical office environment with moderate noise level.
- Ability to stand, walk, reach, climb or balance, stoop or crouch, sit and hand/wrist use, talk, see, and hear for extended periods of time.
- Ability to prepare and interpret reports. Must be able to add, subtract, multiply and divide, using whole numbers, common fractions and decimals.
- Ability to carry out instructions given in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in routine situations.
- Ability to lift up to 25 - 50 lbs.
- Travel may be required.
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