Support Clinical Research Study teams in all aspects of clinical trial conduct from site identification/feasibility through study close out and CSR generation.
Essential Duties and Responsibilities (includes but is not limited to):
- Support Global Head of Clinical Research, Clinical Research Study Managers and CRAs in all aspects of the conduct of Clinical Research Trial from site identification through closeout/CSR generation
- Develop and maintain strong relationships with CROs, Vendors and Investigators to ensure effective execution of clinical studies.
- Ability to maintain multiple tracking systems related to study details, training and trial metrics
- Key participant to establish key performance indicators (site activation, subject screening and enrollment, CRF completion monitoring status, etc.) and apply to ensure the successful execution of clinical trials to agreed timelines.
- Assist with budget and contract processing, support clinical research managers in sending/processing budget and contract materials
- Oversees adherence to study timeline, quality, and budget for assigned studies
- Proactively identify potential risks and issues that may arise with studies, CROs, and vendors, and make recommendations to address in an effective manner.
- Assist with site feasibility activities/non-disclosure agreements
- Assist with collection of regulatory documents
- Support data management activities/data management team: run reports/create listings from EDC, distribute to relevant team members and sites as needed
- Print, assemble and ship start-up materials to investigator sites
- Track and ship trial equipment
- Receive and track returned equipment
- Distribute study plans and correspondence to relevant team members
- Distribute and track correspondence to investigator sites and study vendors
- Schedule/coordinate in-house and off-site meetings and training sessions
- Attend study team meetings, produce and distribute meeting minutes
Secondary Duties and Responsibilities:
- Contribute to department process development/best practice
- Adhere to GCP/ICH guidelines and Acumen SOPs.
- 2+ years experience in a CRA/Clinical Trial Project Management role within the pharmaceutical/biotech or CRO industry
Education, License, Certification, or Preferred Qualifications:
- University/college degree preferred, but not required (STEM degree preferred)
- Excellent communication and organizational skills.
- Must be flexible and able to work in a dynamic, fast paced environment.
- Position is located in Carmel, Indiana
- Position will require some on-site/in-person training and will require CRA to be on-site to prepare and ship study supplies/equipment as needed in support of start-up activities
- Must be willing and able to be on-site/in-person when COVID-19 restrictions subside
Tools and Technology Used:
- Microsoft Office 365 (Word, Excel, PowerPoint, Teams, Outlook)
- DocuSign and Adobe
Work Environment & Mental and Physical Requirements:
- This job operates primarily in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and other common office equipment and accessories.
- Ability to remain in a stationary position; move; operate and use required equipment; and reach items
- Ability to move/transport up to 30 lbs., and up to 50 lbs. occasionally.
- Ability to communicate, converse with others, and exchange information
Compensation and Benefits:
Competitive base salary, annual incentive bonus and company stock options. Package details based on qualifications and track record of performance.
Competitive benefits package including health, dental, vision, life insurance and 401K. Schedule flexibility and Competitive paid time off
About Acumen Pharmaceuticals, Inc.
Acumen Pharmaceuticals, Inc., is a privately held company with offices in Charlottesville, VA and Carmel, IN. Acumen is developing targeted therapies for the safe and effective treatment of Alzheimer’s Disease and related neurodegenerative diseases. Acumen’s lead program, ACU193, is a monoclonal antibody which binds to amyloid beta oligomers which are widely acknowledged to be major mediators of Alzheimer’s Disease pathology. Acumen plans to initiate human clinical studies of ACU193 in 2021 and is seeking to add key contributors to support the development of ACU193 and the growth of the company.
Equal Employment Opportunity
Acumen Pharmaceuticals provides equal employment opportunities to all employees and applicants in all company facilities without regard to race, color, religious creed, sex, national origin, ancestry, citizenship status, pregnancy, childbirth, (or related medical conditions, including, but not limited to lactation), physical disability, mental and/or intellectual disability, age, military status or status as a Vietnam-era or special disabled veteran, marital status, registered domestic partner or civil union status, gender (including sex stereotyping and gender identity or expression), medical condition (including, but not limited to, cancer related or HIV/AIDS related), genetic information, or sexual orientation in accordance with applicable federal, state and local laws.
Accommodation of Disabilities
Acumen Pharmaceuticals is committed to making every reasonable effort to accommodate an employee’s disability. An accommodation may be provided if the employee can perform the essential duties of the job, and it does not create an undue hardship for the company. A reasonable accommodation may include changes in the work environment or in the way a job is performed, so a person with a disability may enjoy equal employment.